INSTITUTION PROFILE / BIOSENSORS
CLSI (Clinical and Laboratory Standards Institute)
The US non-profit that standardises how laboratory tests, point-of-care tests and glucose measurements are evaluated
CLSI is a US non-profit membership organisation that develops consensus-based standards and guidelines for medical laboratories and in vitro diagnostics (IVDs). It does not make sensors, and it does not approve products. Its relevance to biosensors lies in documents on how performance is evaluated, covering precision, interference, detection limits and method comparison, and in a document on performance metrics for continuous glucose monitoring (CGM). CLSI documents carry no legal force on their own, but the U.S. Food and Drug Administration (FDA) lists some of them as "recognized consensus standards" against which manufacturers can make a declaration of conformity. This profile looks at one question: how much influence CLSI actually has over biosensors, in terms of the kind of power it holds and how far that power reaches.
- CLSI in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- From draft to use
- Outlook
- Glossary, references and claim-to-source audit
1. CLSI in 30 seconds
CLSI documents are consensus standards that manufacturers and laboratories choose to use. Using them is voluntary. They gain force when the FDA takes them into its own system. The FDA lists "voluntary consensus standards for which it will accept a declaration of conformity" in its recognized standards database, and, as CLSI itself notes, the FDA may recognise a standard in whole, in part, or not at all Sourced. For example, the second edition of CLSI POCT05, on performance metrics for CGM, is entered in the FDA database with a date of 7 June 2021 and recognised in full Sourced. Being on that list, however, does not mean that a product has been approved. The FDA, not CLSI, decides approval and conformity.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in biosensor coverage do not make sensors. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for biosensors
CLSI publishes documents across laboratory medicine, including microbiology and molecular testing. Those relevant to biosensors are mainly documents that set out how to verify measurement performance experimentally, and documents specific to glucose measurement (including CGM). The table below draws on CLSI's page for each document and on entries in the FDA's recognized standards database Sourced. The documents themselves are sold (each page lists US$180), so this article relies on the abstracts and status information and does not go into the content.
| Document (as titled by CLSI) | What it covers (CLSI abstract) | Status and FDA recognition |
|---|---|---|
| POCT05, 2nd edition Performance Metrics for Continuous Interstitial Glucose Monitoring | Consensus information for health care professionals, IVD and device manufacturers and regulators on how CGM data should be assessed for accuracy, how systems should be assessed for factors that reduce accuracy, and how they should be operated for best performance. It covers use cases, point and trend accuracy, evaluation of threshold alerts, stability and reliability, clinical studies, calibration, measurement traceability, shelf life, cybersecurity and labelling | Published November 2020 (CLSI's page gives 9 November; its press release is dated 19 November). Reviewed and confirmed in July 2025. Recognised in full by the FDA on 7 June 2021 (recognition number 7-307) |
| POCT06, 1st edition Effects of Different Sample Types on Glucose Measurements | How the type of sample affects glucose results and method comparisons, including pre-examination, examination and physiological considerations. A report to help clinical staff design evaluation protocols | Published May 2015, confirmed June 2020. CLSI's page carries no "FDA-Recognized" label |
| EP09, 3rd edition (EP09c) Measurement Procedure Comparison and Bias Estimation Using Patient Samples | Procedures for determining the bias between two measurement procedures using patient samples: experiment design, difference and scatter plots, and how to evaluate and report bias. For both laboratories and manufacturers | Published June 2018. Recognised in part by the FDA on 6 July 2020 (7-296). A fourth edition is in development (Chapter 6) |
| EP17, 2nd edition (EP17-A2) Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures | Evaluating the limit of blank, limit of detection and limit of quantitation, verifying manufacturers' detection capability claims, and using and interpreting the estimates. For IVD manufacturers, regulators and laboratories | Published June 2012, confirmed June 2017. Recognised in full by the FDA on 15 January 2013 (7-233). A third edition is in development |
| EP07, 3rd edition / EP37, 2nd edition Interference Testing in Clinical Chemistry / Supplemental Tables for Interference Testing in Clinical Chemistry | Screening for potentially interfering substances, quantifying their effects and verifying interference claims. EP37 holds tables of test concentrations for interferents | EP07 published April 2018 and recognised in full by the FDA on 17 September 2018 (7-275). EP37, 2nd edition, recognised in full on 22 December 2025 (7-348) |
| GP42, 7th edition Collection of Capillary Blood Specimens | Collection of capillary blood specimens (as titled in the FDA database; we did not check CLSI's own page) | Recognised in full by the FDA on 21 December 2020 (7-301) |
The FDA's guidance on self-monitoring blood glucose systems (issued 29 September 2020) also refers to CLSI documents by name. It recommends running linearity studies according to CLSI EP6-A, points to CLSI GP-14 as a reference for home-use IVD labelling, and cites CLSI EP-18A2, alongside ISO 14971, for lists of error sources Sourced. In other words, inside a regulator's own document CLSI is used as a model for how to run the tests.
CLSI documents do not set pass criteria for materials such as electrodes, enzyme membranes or adhesives. What they set out is which experiments to run to establish a finished sensor's precision, interference, detection limit and bias against another method Sourced. Our reading is that when a sensor material is changed, the effect would be shown as a difference in performance measured by procedures of this kind Our calculation. Detection limits are covered in our explainer on label-free detection and limit of detection, and interference at the electrode in our explainers on enzyme-electrode interfaces and electrochemical sensors.
4. How far its influence reaches (powers and geography)
| Aspect | What CLSI has | What CLSI does not have |
|---|---|---|
| Powers | It develops and publishes consensus-based standards and guidelines with experts from industry, government and health care. Anyone can propose a project; member delegates vote and the public can comment, and a council checks that the process was followed | Any power to compel adoption, to approve or certify products, or to decide which documents the FDA recognises |
| United States | Some CLSI documents are in the FDA's recognized consensus standards database, and the FDA accepts declarations of conformity against them. FDA guidance also refers to CLSI documents | The outcome of an FDA review such as a 510(k). The FDA can recognise a standard in whole, in part or not at all |
| European Union | European companies may use CLSI documents voluntarily (we did not check this) | Every standard in the EU lists of harmonised standards (IVD Regulation and Medical Device Regulation, generated 17 June 2026) comes from the European Committee for Standardization (CEN). We found no CLSI document in them |
| Japan | The Japanese Committee for Clinical Laboratory Standards (JCCLS) is listed as a partner organisation on CLSI's website | We could not confirm how CLSI documents are treated in Japan's regulatory system |
| Geography | CLSI says its standards are used in more than 155 countries and that it has members in 76 (CLSI's own count) | Any national regulation. The usage figures are self-reported, and we have not verified them independently |
| Scale and funding | 26,250 professional members, over 1,100 member organisations and 1,807 active volunteers. CLSI's pages mention membership, sales of standards and support from donors | A staff headcount could not be found on CLSI's website |
Some CLSI document pages carry an "FDA-Recognized" label. It indicates that the document is in the FDA's database. It does not mean the FDA has approved a product, or that following the document guarantees a review will succeed. The database records whether recognition is "Complete" or "Partial", and some documents are recognised only in part (for example, EP09). CLSI itself says that if its crosswalk and the FDA database disagree, the FDA database is the definitive source Sourced.
5. From draft to use
CLSI documents are produced through a process that gathers input from members, experts and the public. Of the routes by which they are then used, we were able to confirm two from primary sources: voluntary adoption, and declarations of conformity through the FDA's recognized standards.
| Organisation | Relationship with CLSI (as stated on CLSI's website) |
|---|---|
| ISO | In 1997 NCCLS proposed and organised ISO/TC 212 (medical laboratories and in vitro diagnostic systems). CLSI says it has since been responsible for managing ISO/TC 212 and the US Technical Advisory Group. On ISO's own page the secretariat of TC 212 is shown as ANSI (United States) |
| FDA | Listed as a partner. The FDA recognises some CLSI documents as consensus standards (the history page also notes that in 2017 the FDA announced recognition of numerous CLSI standards on antimicrobial susceptibility testing) |
| WHO | In 1985 the organisation was designated a World Health Organization Collaborating Center for clinical laboratory standards |
| Japan | The Japanese Committee for Clinical Laboratory Standards (JCCLS) is listed as a partner organisation |
Where our company profiles in this series (in preparation) discuss how glucose meters, CGM or IVDs are evaluated, these documents appear as ways to run the tests. What a given company actually did under which document is written there only to the extent that the company's own publications confirm it. The differences between regulatory pathways are covered in our explainer on medical device approval categories and home use, continuous glucose monitoring in our explainer of that name, and point-of-care testing in our POCT explainer.
6. Outlook
| What we can read | Primary information behind it | Type |
|---|---|---|
| A fourth edition of EP09 (method comparison) is projected for July 2027 and a third edition of EP17 (detection capability) for August 2027; both are at the "Resolution" stage | CLSI's list of projects in progress. The page says projected dates are subject to change | Sourced |
| The glucose documents POCT12 (acute and chronic care facilities) and POCT13 (settings without laboratory support) are in development as fourth editions projected for July 2030 | CLSI's list of projects in progress | Sourced |
| CLSI POCT05, the CGM performance-metrics document, was reviewed and confirmed in July 2025, but we found no project to revise it in the list of projects in progress | CLSI's POCT05 page and its list of projects in progress (as displayed in October 2026) | Not yet confirmed |
| When new editions appear, the FDA is likely to judge each edition separately for recognition | In the FDA database, EP37 1st edition (17 September 2018) and 2nd edition (22 December 2025) appear under different recognition numbers | Inference |
7. Glossary
- Consensus standard
- A standard developed by agreement among interested parties, whose use is voluntary. At CLSI it is published after a vote by member delegates and a period of public comment.
- Recognized consensus standard
- A voluntary consensus standard for which the FDA has decided to accept a declaration of conformity. The FDA database records whether recognition is complete or partial.
- Declaration of conformity
- A statement by a manufacturer that a device meets a given standard. It can be used in submissions to the FDA.
- POCT
- Point-of-care testing: testing close to the patient. It overlaps with how glucose meters and CGM are used.
- CGM
- Continuous glucose monitoring: continuous measurement of glucose in the interstitial fluid under the skin.
- Limit of detection (LoD)
- The smallest amount that can be distinguished from a blank. EP17 covers evaluation of the limit of blank, limit of detection and limit of quantitation.
8. References
- CLSI About Us (non-profit, number of members, member organisations and volunteers, number of countries using the standards, 300+ standards and guidance products). https://clsi.org/about/
- CLSI History & Impact (founded 1967, NCCLS renamed CLSI in 2005, WHO Collaborating Center in 1985, ISO/TC 212 in 1997, FDA recognition in 2017). https://clsi.org/about/history-impact/
- CLSI Leadership (board with balanced representation from government, industry and the health care professions, committed to the integrity of the consensus process). https://clsi.org/about/leadership/
- CLSI Partners (a 501(c)(3) non-profit; partners including the FDA, ISO, WHO and JCCLS). https://clsi.org/about/partners/
- CLSI Consensus Process (the standards development process from proposal to publication). https://clsi.org/standards-development/consensus-process/
- CLSI FDA-Recognized Consensus Standards (the FDA may recognise all, part or none of a standard; the FDA database is definitive). https://clsi.org/standards-development/fda-recognized-consensus-standards/
- CLSI POCT05 Performance Metrics for Continuous Interstitial Glucose Monitoring (second edition, abstract, confirmed July 2025, FDA-Recognized label, list price). https://clsi.org/shop/standards/poct05/
- CLSI Press release "CLSI Publishes New Edition of CLSI POCT05" (19 November 2020). https://clsi.org/about/news/clsi-publishes-new-edition-of-poct05-performance-metrics-for-continuous-interstitial-glucose-monitoring/
- CLSI POCT06 Effects of Different Sample Types on Glucose Measurements (first edition, published May 2015, confirmed June 2020). https://clsi.org/shop/standards/poct06/
- CLSI EP09 Measurement Procedure Comparison and Bias Estimation Using Patient Samples (third edition, published June 2018, FDA-Recognized label). https://clsi.org/shop/standards/ep09/
- CLSI EP17 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures (second edition, published June 2012, confirmed June 2017, FDA-Recognized label). https://clsi.org/shop/standards/ep17/
- CLSI EP07 Plus Interference Testing in Clinical Chemistry (third edition, published April 2018, relation to EP37, FDA-Recognized label). https://clsi.org/shop/standards/ep07-plus/
- CLSI Projects In Progress (stage and projected publication of EP09 4th ed., EP17 3rd ed., EP37 3rd ed., POCT12 4th ed. and POCT13 4th ed.). https://clsi.org/standards-development/projects-in-progress/
- U.S. Food and Drug Administration (FDA) Recognized Consensus Standards: Medical Devices (database of voluntary consensus standards for which the FDA accepts a declaration of conformity). Title search "Point-of-Care" (POCT05 2nd ed., GP42 7th ed. and others). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Point-of-Care&Search=Search
- FDA Same database, title search "Measurement Procedure Comparison" (EP09c 3rd ed., recognised in part). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Measurement+Procedure+Comparison&Search=Search
- FDA Same database, title search "Detection Capability" (EP17-A2, recognised in full). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Detection+Capability&Search=Search
- FDA Same database, title search "Interference Testing" (EP07 3rd ed., EP37 1st and 2nd eds.). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Interference+Testing&Search=Search
- FDA Guidance "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" (issued 29 September 2020; references to CLSI EP6-A, GP-14 and EP-18A2). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use
- European Commission Summary list of harmonised standards for the IVD Regulation (generated 17 June 2026; all listed standards come from CEN). https://single-market-economy.ec.europa.eu/document/download/bea20714-7793-43ad-9a76-ef2a96ac8e45_en?filename=SummaryListForLegislation_2017_746%201.30.2026.pdf
- European Commission Summary list of harmonised standards for the Medical Device Regulation (generated 17 June 2026; all listed standards come from CEN). https://single-market-economy.ec.europa.eu/document/download/40f686be-acf4-4a0b-b6d2-20a00f46a8bc_en?filename=SummaryListForLegislation_20.10.2025.pdf
- ISO ISO/TC 212 Medical laboratories and in vitro diagnostic systems (secretariat: ANSI). https://www.iso.org/committee/54916.html
- CLSI Privacy Policy (postal address in Malvern, Pennsylvania). https://clsi.org/privacy-policy/
9. Claim-to-source audit
| Claim in the text | Type | Source |
|---|---|---|
| Founded 1967; NCCLS renamed CLSI in 2005; WHO Collaborating Center in 1985; ISO/TC 212 proposed and managed from 1997 | Sourced | Reference 2 https://clsi.org/about/history-impact/ |
| 26,250 professional members, 1,100+ member organisations, 1,807 volunteers, 300+ standards, 155+ countries using them, members in 76 countries (CLSI's own counts) | Sourced | Reference 1 https://clsi.org/about/ |
| A 501(c)(3) non-profit; partners include the FDA, ISO, WHO and JCCLS | Sourced | Reference 4 https://clsi.org/about/partners/ |
| The board is described as balanced between government, industry and the health care professions | Sourced | Reference 3 https://clsi.org/about/leadership/ |
| Postal address in Malvern, Pennsylvania | Sourced | Reference 22 https://clsi.org/privacy-policy/ |
| The standards development process (proposal, council approval, drafting, vote and comment, approval, publication) | Sourced | Reference 5 https://clsi.org/standards-development/consensus-process/ |
| The FDA may recognise a standard in whole, in part or not at all; the FDA database is definitive | Sourced | Reference 6 https://clsi.org/standards-development/fda-recognized-consensus-standards/ |
| POCT05 2nd edition: abstract, confirmed July 2025, FDA-Recognized label | Sourced | Reference 7 https://clsi.org/shop/standards/poct05/ |
| POCT05 publication date (CLSI page 9 November; press release 19 November) | Sourced | Reference 7 https://clsi.org/shop/standards/poct05/ Reference 8 https://clsi.org/about/news/clsi-publishes-new-edition-of-poct05-performance-metrics-for-continuous-interstitial-glucose-monitoring/ |
| FDA database entries for POCT05 2nd ed. (7 June 2021, 7-307) and GP42 7th ed. (21 December 2020, 7-301), both recognised in full | Sourced | Reference 14 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Point-of-Care&Search=Search |
| POCT06: abstract, published May 2015, confirmed June 2020, no FDA-Recognized label | Sourced | Reference 9 https://clsi.org/shop/standards/poct06/ |
| EP09 3rd edition: abstract, published June 2018; recognised in part by the FDA (6 July 2020, 7-296) | Sourced | Reference 10 https://clsi.org/shop/standards/ep09/ Reference 15 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Measurement+Procedure+Comparison&Search=Search |
| EP17 2nd edition: abstract, published June 2012, confirmed June 2017; recognised in full by the FDA (15 January 2013, 7-233) | Sourced | Reference 11 https://clsi.org/shop/standards/ep17/ Reference 16 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Detection+Capability&Search=Search |
| EP07 and EP37: abstracts and FDA recognition (EP07 on 17 September 2018; EP37 2nd ed. on 22 December 2025) | Sourced | Reference 12 https://clsi.org/shop/standards/ep07-plus/ Reference 17 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Interference+Testing&Search=Search |
| FDA guidance on self-monitoring blood glucose systems cites CLSI EP6-A, GP-14 and EP-18A2 | Sourced | Reference 18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use |
| All standards in the EU lists of harmonised standards (IVDR and MDR) come from CEN; no CLSI document appears | Sourced | Reference 19 https://single-market-economy.ec.europa.eu/document/download/bea20714-7793-43ad-9a76-ef2a96ac8e45_en?filename=SummaryListForLegislation_2017_746%201.30.2026.pdf Reference 20 https://single-market-economy.ec.europa.eu/document/download/40f686be-acf4-4a0b-b6d2-20a00f46a8bc_en?filename=SummaryListForLegislation_20.10.2025.pdf |
| The secretariat of ISO/TC 212 is ANSI | Sourced | Reference 21 https://www.iso.org/committee/54916.html |
| Projected editions: EP09 4th (July 2027), EP17 3rd (August 2027), POCT12 4th and POCT13 4th (July 2030) | Sourced | Reference 13 https://clsi.org/standards-development/projects-in-progress/ |
| EP37 1st (2018) and 2nd (2025) editions appear in the FDA database under different recognition numbers | Sourced | Reference 17 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=Interference+Testing&Search=Search |
| The four-type classification, the summary of the flow in Fig. 2, and the materials engineer's reading | Our calculation | Our own grouping, based on References 5 to 7 and 14 to 18 |
| A project to revise POCT05, treatment of CLSI documents in Japan's regulatory system, voluntary use by EU companies, staff headcount | Not yet confirmed | Not found on CLSI's official pages or its list of projects in progress. This article does not estimate them |
| The FDA is likely to judge each new edition separately | Inference | Our reading of how recognition numbers are assigned (Reference 17); this article's interpretation |
Last updated 4 October 2026 / Troy Technical
This article summarises standards and regulation from the official materials of CLSI, the FDA, the European Commission and others. It is not advice on diagnosis, treatment or the reading of any individual's measurements. Items marked "Inference" are this article's reading of the primary information.