COMPANY PROFILE / BIOSENSORS
ARKRAY
A Kyoto specialist in diabetes testing equipment for laboratories, clinics and homes; blood glucose self-monitoring is one part, and financials are disclosed only for the group's sales
ARKRAY comes up in any discussion of biosensors because it is a Japanese specialist that has made single-use blood glucose sensors (test strips) and meters, based on an enzyme and an electrode, since the 1970s. According to the company profile on its website, group sales were ¥56.9 billion (fiscal year to October 2025) and the group had 2,091 employees (1 November 2025). The business is described in three layers: instruments for large hospitals, point-of-care testing for smaller hospitals and clinics, and self-monitoring meters for patients, with functional food ingredients on the side. According to FDA documents, the company's glucose test strips (GLUCOCARD W and Assure Titanium) are amperometric and use the enzyme glucose oxidase, and in Assure Titanium the mediator is hexaammineruthenium(III) chloride. That is a typical biosensor. This profile sets out what can be confirmed from official documents and what is not disclosed. No continuous glucose monitoring (CGM) product appears in the documents reviewed.
- ARKRAY in 30 seconds, and where it stands in biosensors
- The logo and how the name is written
- Where the company sits in the field
- Scale
- Resources committed to biosensors
- What it has done so far
- What comes next
- What the company is aiming for in biosensors
- Map of partnerships in biosensors
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. ARKRAY in 30 seconds, and where it stands in biosensors
Diabetes self-monitoring (secondary)No continuous glucose monitoring product confirmed
dry chemistryGlucose is measured with an enzyme and an electrode (amperometry)
ARKRAY is best understood not as "a continuous glucose monitoring company" but as "a maker of diabetes-centered testing instruments and reagents for three places (laboratory, clinic and home), of which self-monitoring meters are one part" Our calculation. The website describes its businesses as for large hospitals and research institutions, for smaller hospitals and clinics, and for patients, but does not disclose sales for each Sourced. What share of group sales comes from self-monitoring meters could not be confirmed either Not yet confirmed.
2. The logo and how the name is written
A note on names: the legal entity is ARKRAY, Inc. (Arkray Kabushiki Kaisha in Japanese). The brand logo is set in lower case ("arkray"). The company was founded as Kyoto Daiichi Kagaku and took its present name in June 2000 (company history). The group has several companies, including ARKRAY Marketing, ARKRAY Factory and ARKRAY Infinity, so the applicant for a product's approval or certification differs from product to product. GLUCOCARD, Assure, ADAMS, AUTION, SPOTCHEM and The Lab are product or brand names, not company names. The logo image was taken from the company's official website.
Official site: https://www.arkray.co.jp/english/3. Where the company sits in the field
4. Scale
ARKRAY does not disclose detailed financials. The company profile on its website gives only group sales, headcount and the fiscal-year span (November to October) Sourced.
| Indicator | Figure | Date and note |
|---|---|---|
| Sales (whole group) | ¥56.9 billion | Fiscal year to October 2025 (company profile) |
| Employees (whole group) | 2,091 | 1 November 2025 (company profile) |
| Operating profit, net profit, capital, R&D spending, capital expenditure | Not disclosed | Not in the company profile or brochure |
| Sales by business (instruments, self-monitoring meters, functional food ingredients) | Not disclosed | The business page describes content only |
The company history records milestones in sales: ¥10 billion in 1990, ¥20 billion in 1995 and ¥50 billion in 2002. The history does not say whether these were parent-only or consolidated figures Sourced.
The group is split into sales companies (ARKRAY Marketing, ARKRAY Global Business), manufacturing companies (ARKRAY Factory, ARKRAY Infinity), R&D and software companies and others, with production and sales sites abroad in the United States, the United Kingdom, Ireland, the Philippines, China, Russia and elsewhere (company history and group page). Which company makes and markets which product differs by product (for example, the HbA1c reagent "Sanku HbA1c" is made and marketed by ARKRAY Factory). Whether the company is listed is not stated in official documents. It is probably unlisted, but this article has not confirmed it Not yet confirmed.
5. Resources committed to biosensors
ARKRAY does not disclose R&D spending, capital expenditure or R&D headcount. The table sets out what could be confirmed from the company history and news.
| Resource | What primary sources confirm | Category |
|---|---|---|
| People | 2,091 employees across the group (1 November 2025). R&D bases include the Kyoto Research Institute (operating from 2011), the Nagasaki Development Center (August 2020), the Osaka Development Center (February 2024), a development site in Xi'an, China (2012) and an R&D base in Singapore (2013) (company history). The number of R&D staff is not disclosed | Sourced / partly undisclosed |
| Money | R&D spending and capital expenditure are not disclosed. Facilities mentioned: a manufacturing base in the Philippines (established 2011; an instrument factory and logistics building completed in January 2016), Pinghu, China (2014), the United Kingdom (2009), the United States (2006), Russia (2013), Ireland (December 2021) and the Konan plant in Shiga (1990) | Undisclosed / Sourced (sites) |
| Acquisitions, investments, alliances, business transfers | In 2004 a business and capital alliance with MC Kenkyusho (MC Institute); in 2007 a joint venture in India with a pharmaceutical company (ARKRAY PIRAMAL Medical); in 2009 an investment in ELITECH France SAS; in 2013 a capital and business alliance with Boditech Med of Korea; in 2015 completion of a business transfer from Span Diagnostics Ltd. to ARKRAY Healthcare Pvt. Ltd. In September 2025 the company agreed to transfer the manufacture and marketing of its HbA1c reagent "Sanku HbA1c" to Shino-Test Corporation (planned for 2026). No amounts are given. On supply, PHC Corporation's materials list ARKRAY, Inc. as the delivery destination (OEM) for a self-monitoring blood glucose system (not mentioned in ARKRAY's documents) | Sourced |
| Universities, research institutions, public funding | Joint research with 14 sites, including Kyoto University, Kindai University and Kyoto Prefectural University of Medicine (identifying pancreatic cancer from blood microRNA; published in the British Journal of Cancer in August 2024). Funding listed for the project as a whole includes ARKRAY research funds, JSPS grants, AMED, the Moonshot program and JST. ARKRAY's share is not disclosed, and no public funding specific to glucose sensor research could be found | Sourced / partly not found |
Regulatory status (as far as could be confirmed)
For the United States, entries were checked against the FDA 510(k) database (updated 21 September 2026) and decision documents. Thirty-four 510(k) records list ARKRAY (or an affiliate) as applicant. All are 510(k) clearances; none is a PMA approval or De Novo authorization. For Japan, the numbers below are those given in company announcements; they were not cross-checked against the PMDA public database Sourced.
| Product | Use (summary of the official document) | Category and date | Number |
|---|---|---|---|
| Assure Titanium Blood Glucose Monitoring System | A prescription-only system for healthcare professionals that quantifies glucose in fresh fingertip capillary whole blood. Intended for multiple-patient use in endocrinology clinics and nursing or skilled nursing facilities, with single-use auto-disabling lancing devices. Not for screening or diagnosing diabetes, not for acute care or hospital settings, not for neonates. Amperometric | 510(k) clearance (Dual Track), Class II (21 CFR 862.1345). 23 May 2022 | K200788 |
| GLUCOCARD W onyx Blood Glucose Monitoring System | Quantifies glucose in fresh capillary whole blood from the fingertip or palm. For use at home by one person with diabetes to check the effectiveness of a diabetes control program. Not to be shared; not for diagnosing or screening for diabetes or for neonates. Electrochemical, using glucose oxidase | 510(k) clearance (Special), Class II. 10 April 2019 (applicant Arkray Factory, Inc.) | K183306 |
| GLUCOCARD W Blood Glucose Monitoring System | The predecessor of the W onyx (the document says the W onyx uses the same test strips and technology) | 510(k) clearance (Traditional). 16 August 2017 | K170064 |
| ADAMS A1c HA-8180V | An HbA1c analyzer (product code PDJ). The use statement was not checked here | 510(k) clearance (Traditional). 29 June 2017 | K162822 |
| AUTION EYE AI-4510 / AUTION MAX AX-4060 | A urine particle analysis system / a urinalysis system (laboratory). The use statements were not checked here | 510(k) clearance. 3 May 2024 / 13 April 2023 | K232416 / K193514 |
| Rapid Chip BNP-II (name transliterated from Japanese) | Measures BNP in plasma or whole blood. Immunochromatography, 120 µL sample, about 10 minutes, measuring range 10 to 800 pg/mL (manufacturer's stated values). Used with the dedicated analyzer Rapidpia II | Japan: in vitro diagnostic reagent, certification number 305ADEZX000580000 (company announcement). On sale from 7 September 2026 | - |
| SillHa Kenshin LH-4920 and test paper | An oral-environment measurement system that qualitatively measures hemoglobin in mouth-rinse liquid. The company states it supports diagnosis and does not make a definitive diagnosis | Japan: the instrument is a Class I notified device (notification number 25B1X00001000070); the test paper is an in vitro diagnostic reagent (certification number 308AAEZX00014000) (company announcement). On sale from 15 July 2026 | - |
| GLUCOCARD Prime / Plus Care (Japan) | Self-monitoring blood glucose meters. The company states conformity with ISO 15197:2013. The product page gives no approval or certification number and refers readers to the PMDA site for the latest | Japan: number not confirmed | - |
The status of each product under the EU In Vitro Diagnostic Regulation (IVDR) could not be confirmed here Not yet confirmed. The FDA recall database has six records under ARKRAY's U.S. entities between 2007 and 2019 (titles and dates only; for example a 2007 Hypoguard blood glucose monitoring system, 2015 SPOTCHEM II test strips and 2019 software for the AUTION HYBRID) Sourced. For regulatory categories and how they differ from home use, see our explainer on medical device approval categories and home use.
Even where financials are undisclosed, how materials are used in glucose measurement can be confirmed from FDA documents and company announcements. In the Assure Titanium strip, blood is drawn in by capillary action at the tip, where glucose oxidase (GOD) and hexaammineruthenium(III) chloride react to form ruthenium(II); the current from oxidizing it at the electrode is read by the meter and converted to a glucose value (FDA document). The laboratory glucose analyzer ADAMS Glucose GA-1180 likewise uses an enzyme membrane with immobilized GOD and a hydrogen peroxide electrode, measured by amperometry (company announcement) Sourced. From a materials standpoint, the stability of the enzyme, a mediator that is not disturbed by other substances in blood, the area and reproducibility of the electrode, and a flow path that draws in a fixed volume bear on accuracy in whole blood Not yet confirmed. However, the electrode materials, enzyme modifications and layer structure of the strip are not given in the documents retrieved. See our explainers on enzyme and electrode interface materials and on electrochemical sensors.
6. What it has done so far
| When | Event | Meaning |
|---|---|---|
| June 1960 | Its founder established Kyoto Daiichi Kagaku in Kyoto, beginning with optical parts for infrared instruments | Started from precision parts for measuring instruments |
| 1970 | Developed a simple blood glucose meter ("Aitone") and a rapid blood analyzer; won prizes at European trade fairs in 1974 and 1975 | The company records blood glucose meters as far back as 1970 |
| 1979 | Developed a continuous blood glucose measuring device ("Glucose Monitor") (company history) | Not the same as today's wearable CGM; no further detail could be confirmed |
| 1981 | Developed the world's first automated glycohemoglobin fractionation analyzer (AUTO A1c) | Automation of HbA1c testing |
| 1991 | Developed the simple self-monitoring blood glucose system "GLUCOCARD" | Origin of the current brand |
| 1992 | Developed an automated glycated albumin analyzer and proposed glycated albumin as a new index for diabetes management | A glycemic index other than HbA1c |
| 1995 | Introduced the corporate brand "ARKRAY"; lent blood glucose meters free of charge after the Great Hanshin earthquake | Company statement |
| 2004-2013 | Alliance with MC Kenkyusho (2004), an Indian joint venture (2007), an investment in ELITECH France (2009), a capital and business alliance with Boditech Med (2013) | Alliances and overseas expansion |
| May 2008 | Began selling self-monitoring blood glucose meters for diabetes patients under its own sales organization in Japan | Direct sales to the home market |
| June 2020 | Developed the GLUCOCARD Prime self-monitoring meter (the company states conformity with ISO 15197:2013) | A current main model |
| 23 May 2022 | Assure Titanium received FDA 510(k) clearance (prescription, for healthcare professionals) | A blood glucose meter for healthcare professionals |
| January-March 2024 | Launched a COVID-19 and influenza antigen test kit (about 5 minutes) and updated its glucose analyzer to ADAMS Glucose GA-1180 | Updates to laboratory and rapid-test lines |
| 28 August 2024 | With Kyoto University and others, published a blood microRNA model for identifying pancreatic cancer | A research result; commercialization has not been announced |
| March 2025 | Moved its headquarters within Nakagyo-ku, Kyoto; set up a sales base in Thailand | - |
| 5 September 2025 | Agreed to transfer the manufacture and marketing of the HbA1c reagent "Sanku HbA1c" to Shino-Test | A move to let go of one HbA1c reagent business |
| 9 March 2026 | Warned that websites selling a non-invasive glucose meter under its name have nothing to do with ARKRAY | A company statement. No report that the company has commercialized non-invasive glucose measurement could be found |
| 15 July 2026 | Launched the oral-environment measurement system SillHa Kenshin LH-4920 | A new area beyond glucose |
| 4 September 2026 | Announced Rapid Chip BNP-II (on sale 7 September) | An addition to rapid tests usable near the patient |
7. What comes next
The primary sources also describe the following plans Not yet confirmed.
- For the microRNA pancreatic-cancer model, the August 2024 announcement says the partners plan to continue R&D toward practical use, including validation in high-risk groups. No timing for a product is given
- The president's 2026 New Year address (summary) sets out the "three thoroughnesses" as guiding principles for the year and more reskilling for AI use; it contains no numerical targets or new-product plans
Operating profit, R&D spending, capital expenditure and sales by business / whether the company is listed / the share of self-monitoring meters in sales and unit volumes / approval or certification numbers in Japan for each product / the status under the IVDR / whether the company has any continuous glucose monitoring product or development / the detailed materials and structure of the sensor strips. None appears in the official documents retrieved.
8. What the company is aiming for in biosensors
This section separates what the company says it is aiming for from what this article reads into the record. Inference marks interpretation drawn by this article from primary sources.
| What can be read | Primary source behind it | Category |
|---|---|---|
| It aims at testing that links three places: laboratory, clinic and home | The business page lists products in three layers (large hospitals, smaller hospitals and clinics, patients) and says it also provides data management systems | Sourced (company explanation) |
| It is extending rapid tests (immunochromatography) | The COVID-19 and influenza antigen kit (2024) and Rapid Chip BNP-II (2026) | Sourced |
| It is widening beyond diabetes (oral health, cancer, veterinary care) | SillHa (oral environment), the microRNA pancreatic-cancer research, and the veterinary brand thinka | Sourced |
| It is letting go of an HbA1c reagent while focusing on instruments and rapid tests | The agreement to transfer Sanku HbA1c; new instruments and rapid tests launched around the same time | Sourced (transfer) / Inference (where it is focusing) |
| It has probably not entered continuous glucose monitoring (CGM) | No CGM appears in the official product information or news. It states that a non-invasive glucose meter using its name is unrelated | Inference (an absence read as meaning; whether development exists is unknown) |
The reading that "ARKRAY has probably not entered CGM" rests on the absence of CGM from the official product list and news. The website's product information lists large instruments, small instruments, health screening, healthcare, diabetes treatment support (self-monitoring meters, lancing devices and management apps) and veterinary care, but no wearable continuous measurement product Sourced. The March 2026 notice also says that a non-invasive glucose meter using the company name has "nothing to do with" it. However, that does not show that no development or partnership exists outside the website. This article confirmed only the absence Not yet confirmed.
9. Map of partnerships in biosensors
The relationships that can be confirmed are investments and capital alliances, a joint venture, a business transfer, joint research and a supply link from PHC. PHC Holdings' 2026 company overview lists, among the OEM supply that PHC Corporation provides to domestic partners, a self-monitoring blood glucose system with ARKRAY, Inc. as the delivery destination Sourced. ARKRAY's own documents do not mention this supply, so which model it covers, and for which market, could not be confirmed (in FDA filings, GLUCOCARD W and others are filed in the name of Arkray Factory, Inc.) Not yet confirmed. No other supplier of test strips or parts is named in ARKRAY's documents. In FDA filings, the same blood glucose system is listed under more than one brand, such as "GLUCOCARD 01" and "ReliOn Confirm", but the sales relationship behind that could not be confirmed from the official documents retrieved Not yet confirmed.
10. Technologies, products and services
The product information on the company website is divided into large instruments, small instruments, health screening, healthcare, diabetes treatment support and veterinary care. The table focuses on those closest to biosensors. All figures are manufacturer's stated values; test conditions and editions differ, so no ranking is made between products, or against other companies' products Sourced.
| Category | What the official sources say | Comment |
|---|---|---|
| Home: GLUCOCARD self-monitoring meters | GLUCOCARD Prime: about 0.6 µL of blood; measurement time 5.5 seconds (G sensor) or 7 seconds (Prime sensor) after the drop is detected. The company states conformity with ISO 15197:2013. Also GLUCOCARD Plus Care, the "Natureret" lancing device and the smartphone app "Smart e-SMBG" with a cloud service | Manufacturer's stated values. Electrochemical (FDA documents). How to read an individual's reading is a matter for their healthcare professional |
| For healthcare professionals: Assure Titanium | A prescription blood glucose meter for multiple-patient use in endocrinology clinics and nursing facilities (U.S.). Amperometric, with GOD and hexaammineruthenium(III) (FDA document) | A different use category from a self-monitoring meter for home |
| Laboratory: ADAMS series | HbA1c analyzers (HA-8190V, HA-8380 and others) and glucose analyzers. ADAMS Glucose GA-1180: whole blood, serum, plasma and urine; amperometry with an enzyme membrane carrying immobilized GOD and a hydrogen peroxide electrode; about 30 µL of sample; up to 156 measurements an hour | Manufacturer's stated values. For large hospitals and laboratories |
| Laboratory and clinic: urine and dry chemistry | The AUTION series (urinalysis), SPOTCHEM (dry-chemistry blood biochemistry) and The Lab series (HbA1c, protein, dry chemistry) | The company history presents dry chemistry, reagents on dry test strips, as a feature of the lineup |
| Rapid tests | A COVID-19 and influenza antigen kit (about 5 minutes), Rapid Chip BNP-II (about 10 minutes, immunochromatography), SPOTCHEM FLORA (a mobile immunofluorescence analyzer) and the lactate meter Lactate Pro 2 | Immunochromatography uses antibodies; it is not an electrochemical sensor |
| Oral, veterinary and food ingredients | The oral-environment system SillHa (hemoglobin in mouth rinse), the veterinary brand thinka (glucose meters and urine analyzers for dogs and cats, Vcheck V200 and others) and functional food ingredients (anti-glycation and others) | Areas beyond diabetes |
Electrochemical measurement of glucose in whole blood stacks several materials problems: the stability of the enzyme (GOD and others), the choice of mediator so that other substances in blood do not interfere, the area and reproducibility of the electrode, and a capillary flow path that draws in a fixed volume of blood. The FDA document records that Assure Titanium was evaluated across a claimed hematocrit range of 10 to 70% and that the effect of interfering substances was assessed Sourced. How a strip's design keeps the effects of blood thickness (hematocrit) and co-existing drugs and substances small is the central materials question for this kind of device Not yet confirmed. However, the electrode materials, the type and immobilization of the enzyme, and the layer structure of the strip are not given in the documents retrieved. The laboratory GA-1180 is stated to use "an enzyme membrane with immobilized GOD and a hydrogen peroxide electrode", which shows that enzyme immobilization technology underlies the product.
11. The risks this company carries
| Risk | Detail | Category |
|---|---|---|
| Limited disclosure | Operating profit, R&D spending, capital expenditure and sales by business are all undisclosed, so the scale and changes of the business are hard to check from outside | Not yet confirmed |
| Reshuffling of businesses | An agreement to transfer the HbA1c reagent "Sanku HbA1c" to Shino-Test (September 2025; planned for 2026): the company is letting go of part of its core diabetes testing lineup | Sourced |
| Misuse of the company name | In March 2026 it was reported that social media was directing people to sites selling a non-invasive glucose meter under the ARKRAY name; the company said these have nothing to do with it | Sourced (company announcement) |
| Relationship to continuous glucose monitoring | The position of self-monitoring meters can change as continuous monitoring spreads. Whether ARKRAY has a continuous monitoring product could not be confirmed | Inference |
| Restrictions on use | The U.S. Assure Titanium is prescription-only and its use does not include acute care, hospitals or neonates. GLUCOCARD W onyx is not for diagnosis or screening either | Sourced (FDA documents) |
| FDA recall records | The FDA recall database has six records under ARKRAY's U.S. entities between 2007 and 2019 (facts and dates only; content by title) | Sourced |
| Results still at the research stage | The microRNA pancreatic-cancer model is at the research stage and no commercialization date has been given. It is not for diagnosis or screening | Sourced (company explanation) |
| Confirming the status in Japan | The official page for the self-monitoring meters gives no approval or certification number. A check against the PMDA database was not done here | Not yet confirmed |
12. Glossary
- Self-monitoring of blood glucose (SMBG)
- Measuring one's own blood glucose from a small blood sample, usually from a fingertip, with a meter and a single-use test strip (sensor). How to read results and use them in treatment depends on the instructions of a healthcare professional.
- HbA1c (glycohemoglobin)
- Hemoglobin in red blood cells to which glucose has bound. A test item that reflects blood glucose over roughly the previous one to two months.
- Glycated albumin
- Albumin in the blood to which glucose has bound. A test item that reflects blood glucose over a shorter period than HbA1c.
- Amperometry
- A method in which a voltage is applied to an electrode and concentration is derived from the current that flows in the reaction. Widely used in glucose meters.
- Mediator
- A substance that carries electrons between the enzyme and the electrode. In Assure Titanium it is hexaammineruthenium(III) (FDA document).
- Dry chemistry
- A format in which reagents are carried on a dry strip or film, so that blood and other samples can be tested without liquid reagents.
- Immunochromatography
- A method that uses antibodies to capture and detect a target substance as the sample flows along a test strip.
- BNP
- Brain natriuretic peptide, a protein measured in blood in connection with strain on the heart. How to read the result is a matter for healthcare professionals.
- ISO 15197
- The international standard for the performance of blood glucose monitoring systems. ARKRAY states conformity with the 2013 edition.
- 510(k) clearance
- The U.S. FDA route for devices found substantially equivalent to a device already on the market. Distinct from PMA approval and De Novo authorization. "Dual Track" means a 510(k) filed together with a CLIA waiver application.
- In vitro diagnostic reagent (Japan)
- A category under Japanese law for reagents used to test samples such as blood outside the body. The instrument is regulated separately as a medical device.
13. References
- ARKRAY Company profile (in Japanese). Company name, representative, address, founding and incorporation dates, sales (whole group, fiscal year to October 2025) and headcount (whole group, 1 November 2025). https://www.arkray.co.jp/japanese/about/profile.html
- ARKRAY Corporate Outline (English). Sales JPY 56.9 billion (All ARKRAY group) as of October 2025; 2,091 employees; fiscal year. https://www.arkray.co.jp/english/about/profile.html
- ARKRAY Business overview (in Japanese). Medical testing systems (for large hospitals and research institutions, for smaller hospitals and clinics, for patients) and functional food ingredients. https://www.arkray.co.jp/japanese/about/business.html
- ARKRAY ARKRAY Group (in Japanese). The sales, manufacturing, logistics and software companies of the group. https://www.arkray.co.jp/japanese/about/group02.html
- ARKRAY History, 1960s (in Japanese). Founding, incorporation and early products. https://www.arkray.co.jp/japanese/about/history1960.html
- ARKRAY History, 1970s (in Japanese). The simple blood glucose meter "Aitone", the Glucose Monitor and prizes. https://www.arkray.co.jp/japanese/about/history1970.html
- ARKRAY History, 1980s (in Japanese). The world's first automated glycohemoglobin fractionation analyzer (AUTO A1c) and others. https://www.arkray.co.jp/japanese/about/history1980.html
- ARKRAY History, 1990s (in Japanese). GLUCOCARD, glycated albumin, sales milestones and brand introduction. https://www.arkray.co.jp/japanese/about/history1990.html
- ARKRAY History, 2000s (in Japanese). Name change, overseas expansion, alliances, investments, the joint venture and the start of direct sales. https://www.arkray.co.jp/japanese/about/history2000.html
- ARKRAY History, 2010s (in Japanese). Research and manufacturing bases, the alliance with Boditech Med, the business transfer from Span Diagnostics and the product timeline. https://www.arkray.co.jp/japanese/about/history2010.html
- ARKRAY History, 2020s (in Japanese). The Nagasaki and Osaka development centers, overseas bases, the headquarters move and GLUCOCARD Prime. https://www.arkray.co.jp/japanese/about/history2020.html
- ARKRAY News 2026, What's New (in Japanese). The list of items including Rapid Chip BNP-II, SillHa Kenshin and the notice about name misuse. https://www.arkray.co.jp/japanese/news/2026/index.html
- ARKRAY Announcement "Rapid Chip BNP-II launched: BNP measured from whole blood or plasma in about 10 minutes" (4 September 2026; in Japanese). Measurement principle, sample volume, range and certification number. https://www.arkray.co.jp/japanese/news/into/info20260904_jp_jp.html
- ARKRAY Announcement on the oral-environment measurement system "SillHa Kenshin LH-4920" (30 September 2026; in Japanese). Notification and certification numbers and the listing in the Ministry of Health, Labour and Welfare pilot project. https://www.arkray.co.jp/japanese/news/press/release20260930_jp_jp.html
- ARKRAY Important notice on non-invasive blood glucose meters that use the ARKRAY name (9 March 2026; in Japanese). https://www.arkray.co.jp/japanese/news/into/20260306_02.html
- ARKRAY Announcement on the transfer of the manufacture and marketing of the in vitro diagnostic reagent "Sanku HbA1c" (5 September 2025; in Japanese). https://www.arkray.co.jp/japanese/news/into/20250905.html
- ARKRAY / Kyoto University and others Announcement "Research toward a pancreatic cancer diagnostic using blood microRNA" (28 August 2024; in Japanese). The 14 sites, funding and future plans. https://www.arkray.co.jp/japanese/news/press/release_20240828_jp_jp.html
- ARKRAY Announcement "Glucose analyzer model change: ADAMS Glucose GA-1180" (22 March 2024; in Japanese). Measurement principle and specifications. https://www.arkray.co.jp/japanese/news/press/release_20240322_jp_jp.html
- ARKRAY Summary of the 2026 New Year address (5 January 2026; in Japanese). https://www.arkray.co.jp/japanese/news/press/release20260105_jp_jp.html
- ARKRAY GLUCOCARD Prime (product page for the self-monitoring meter; in Japanese). ISO 15197:2013 conformity, required blood volume and measurement time; manufacturer's stated values. https://www.arkray.co.jp/smbg/prime/index.html
- U.S. Food and Drug Administration 510(k) K200788 "Assure Titanium Blood Glucose Monitoring System": clearance letter and summary. Use and measurement principle. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200788.pdf
- U.S. Food and Drug Administration 510(k) K183306 "GLUCOCARD W onyx Blood Glucose Monitoring System": clearance letter and summary (10 April 2019). https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183306.pdf
- U.S. Food and Drug Administration (openFDA) 510(k) database API (records with ARKRAY in the applicant name; the database was last updated on 21 September 2026). Registration details for K170064, K162822, K232416, K193514 and others. https://api.fda.gov/device/510k.json?search=applicant:ARKRAY&limit=40
- U.S. Food and Drug Administration (openFDA) Medical device recall API (records with Arkray in the recalling firm name). https://api.fda.gov/device/recall.json?search=recalling_firm:Arkray&limit=20
- PHC Holdings PHC Group Company Overview (presentation issued May 2026). Lists ARKRAY, Inc. as the delivery destination of a self-monitoring blood glucose system under its diabetes-management OEM partnerships (page 15). https://www.phchd.com/jp/~/Media/phchd/about/PHC_Group_Overview_Presentation_Slide.pdf
- British Journal of Cancer Kawai M, et al. Early detection of pancreatic cancer by comprehensive serum miRNA sequencing with automated machine learning. Br J Cancer 2024; 131: 1158-1168. (DOI, verified through Crossref.) https://doi.org/10.1038/s41416-024-02794-5
14. Claim-to-source audit
| Claim in the text | Category | Source |
|---|---|---|
| Legal name, representative, address, founding in 1960 and incorporation in 1963, fiscal year (November to October) | Sourced | Reference 1 https://www.arkray.co.jp/japanese/about/profile.html Reference 2 https://www.arkray.co.jp/english/about/profile.html |
| Sales of ¥56.9 billion (whole group, fiscal year to October 2025) and 2,091 employees (1 November 2025) | Sourced | Reference 1 https://www.arkray.co.jp/japanese/about/profile.html Reference 2 https://www.arkray.co.jp/english/about/profile.html |
| No disclosure of operating profit, R&D spending, capital expenditure or sales by business | Not yet confirmed | Not in References 1 to 3. Undisclosed; not estimated in this article Reference 1 https://www.arkray.co.jp/japanese/about/profile.html Reference 2 https://www.arkray.co.jp/english/about/profile.html Reference 3 https://www.arkray.co.jp/japanese/about/business.html |
| Whether the company is listed (not stated in official documents) | Not yet confirmed | Not confirmed here. It appears to be unlisted, but that is an inference and we do not claim it Reference 1 https://www.arkray.co.jp/japanese/about/profile.html Reference 2 https://www.arkray.co.jp/english/about/profile.html |
| The three layers of business (large hospitals and research institutions, smaller hospitals and clinics, patients) and functional food ingredients | Sourced | Reference 3 https://www.arkray.co.jp/japanese/about/business.html |
| Sales milestones (¥10 billion in 1990, ¥20 billion in 1995, ¥50 billion in 2002) | Sourced | Reference 8 https://www.arkray.co.jp/japanese/about/history1990.html Reference 9 https://www.arkray.co.jp/japanese/about/history2000.html |
| The division of roles among group companies (sales, manufacturing, logistics, software and others) | Sourced | Reference 4 https://www.arkray.co.jp/japanese/about/group02.html |
| The name change (June 2000) and the original name (Kyoto Daiichi Kagaku) | Sourced | Reference 5 https://www.arkray.co.jp/japanese/about/history1960.html Reference 9 https://www.arkray.co.jp/japanese/about/history2000.html |
| The simple blood glucose meter "Aitone" in 1970, prizes in 1974-75, the Glucose Monitor in 1979 | Sourced | Reference 6 https://www.arkray.co.jp/japanese/about/history1970.html |
| AUTO A1c in 1981, GLUCOCARD in 1991, glycated albumin in 1992, brand introduction in 1995 | Sourced | Reference 7 https://www.arkray.co.jp/japanese/about/history1980.html Reference 8 https://www.arkray.co.jp/japanese/about/history1990.html |
| MC Kenkyusho in 2004, the Indian joint venture in 2007, ELITECH France in 2009, direct sales from 2008 | Sourced | Reference 9 https://www.arkray.co.jp/japanese/about/history2000.html |
| Boditech Med in 2013, the business transfer from Span Diagnostics in 2015, research and manufacturing bases (Kyoto Research Institute, Xi'an, Singapore, the Philippines and others) | Sourced | Reference 10 https://www.arkray.co.jp/japanese/about/history2010.html |
| The Nagasaki and Osaka development centers, overseas bases such as Ireland, the March 2025 headquarters move, GLUCOCARD Prime in 2020 | Sourced | Reference 11 https://www.arkray.co.jp/japanese/about/history2020.html |
| The agreement to transfer Sanku HbA1c to Shino-Test (5 September 2025), planned for 2026 | Sourced | Reference 16 https://www.arkray.co.jp/japanese/news/into/20250905.html |
| Joint research with Kyoto University and 13 other sites (blood microRNA and pancreatic cancer), the funding and the publication | Sourced | Reference 17 https://www.arkray.co.jp/japanese/news/press/release_20240828_jp_jp.html Reference 26 https://doi.org/10.1038/s41416-024-02794-5 |
| Public funding specific to glucose sensor research | Not yet confirmed | Not in Reference 17. Not found. We do not claim that none exists Reference 17 https://www.arkray.co.jp/japanese/news/press/release_20240828_jp_jp.html |
| PHC Corporation lists ARKRAY, Inc. as the delivery destination (OEM) of a self-monitoring blood glucose system | Sourced | Stated in PHC's document; not in ARKRAY's documents, and the model concerned cannot be confirmed. Reference 25 https://www.phchd.com/jp/~/Media/phchd/about/PHC_Group_Overview_Presentation_Slide.pdf |
| Names of suppliers of test strips and parts (ARKRAY's own documents) | Not yet confirmed | Not in ARKRAY's documents. Not found Reference 1 https://www.arkray.co.jp/japanese/about/profile.html Reference 3 https://www.arkray.co.jp/japanese/about/business.html |
| Rapid Chip BNP-II specifications (immunochromatography, 120 µL, about 10 minutes, 10 to 800 pg/mL), certification number 305ADEZX000580000, on sale 7 September 2026 | Sourced | Manufacturer's stated values and company announcement. Reference 13 https://www.arkray.co.jp/japanese/news/into/info20260904_jp_jp.html |
| SillHa Kenshin LH-4920 (notification number 25B1X00001000070, Class I) and test paper (certification number 308AAEZX00014000), on sale 15 July 2026 | Sourced | Reference 14 https://www.arkray.co.jp/japanese/news/press/release20260930_jp_jp.html |
| The notice that a non-invasive glucose meter using the company name is unrelated (9 March 2026) | Sourced | Company announcement. Reference 15 https://www.arkray.co.jp/japanese/news/into/20260306_02.html |
| ADAMS Glucose GA-1180 specifications (immobilized-GOD enzyme membrane and hydrogen peroxide electrode, about 30 µL, up to 156 measurements an hour) | Sourced | Manufacturer's stated values. Reference 18 https://www.arkray.co.jp/japanese/news/press/release_20240322_jp_jp.html |
| GLUCOCARD Prime specifications (about 0.6 µL, 5.5 or 7 seconds) and the ISO 15197:2013 conformity claim | Sourced | Manufacturer's stated values (product page). Reference 20 https://www.arkray.co.jp/smbg/prime/index.html |
| FDA 510(k) clearance of Assure Titanium (K200788, 23 May 2022, Dual Track, prescription use, multiple-patient use) and its measurement principle (GOD, hexaammineruthenium) | Sourced | Reference 21 https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200788.pdf |
| FDA 510(k) clearance of GLUCOCARD W onyx (K183306, 10 April 2019), single-person home use, electrochemical with glucose oxidase | Sourced | Reference 22 https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183306.pdf |
| Registration details of GLUCOCARD W (K170064), ADAMS A1c HA-8180V (K162822), AUTION EYE (K232416) and AUTION MAX (K193514) | Sourced | Database registration details only; use statements not checked. Reference 23 https://api.fda.gov/device/510k.json?search=applicant:ARKRAY&limit=40 |
| Thirty-four FDA 510(k) records listing ARKRAY as applicant | Sourced | Our own search. Reference 23 https://api.fda.gov/device/510k.json?search=applicant:ARKRAY&limit=40 |
| Six FDA recall records (2007-2019) | Sourced | Titles and dates only; no evaluation of the content. Reference 24 https://api.fda.gov/device/recall.json?search=recalling_firm:Arkray&limit=20 |
| Approval or certification numbers in Japan for self-monitoring meters, and status under the IVDR | Not yet confirmed | Not in the documents retrieved. Not confirmed Reference 20 https://www.arkray.co.jp/smbg/prime/index.html |
| The content of the 2026 New Year address (guiding principles, use of AI) | Sourced | It contains no numerical targets. Reference 19 https://www.arkray.co.jp/japanese/news/press/release20260105_jp_jp.html |
| The reading that the company has probably not entered CGM | Inference | This article's interpretation. It confirms only the absence of CGM; it does not show that no development or partnership exists. Reference 12 https://www.arkray.co.jp/japanese/news/2026/index.html Reference 3 https://www.arkray.co.jp/japanese/about/business.html |
| The reading that it is letting go of an HbA1c reagent while focusing on instruments and rapid tests | Inference | This article's interpretation. Reference 16 https://www.arkray.co.jp/japanese/news/into/20250905.html Reference 13 https://www.arkray.co.jp/japanese/news/into/info20260904_jp_jp.html |
| Materials demands of the enzyme, mediator and electrode | Inference | This article's reading of the FDA document and the company announcement (sourced) into materials requirements. Electrode materials and enzyme immobilization are not disclosed. Reference 21 https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200788.pdf Reference 18 https://www.arkray.co.jp/japanese/news/press/release_20240322_jp_jp.html |
| The four types of company (diabetes and continuous monitoring / in vitro diagnostics and POCT / wearables and consumer devices / materials and components) and the example company names | Our calculation | Our own classification. Company names are examples from the companies covered in this series |
| The framing "not a CGM company but a maker of testing instruments and reagents for three places" | Our calculation | Our own framing, drawn from the business overview (Reference 3). |
Last updated 4 October 2026 / Troy Technical
Every figure in this article comes from ARKRAY's website and official announcements and from FDA public documents. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of primary sources, not statements made by the company. ARKRAY does not state in official documents whether it is listed or give detailed financials, so these are recorded as "not disclosed" or "not confirmed".