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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 7-299
CLSI  POCT14 2nd Edition
Point-of-Care Coagulation Testing and Anticoagulation Monitoring
This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg,activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration). POCT14 also includes recommendations for use of point-of care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5400 Fibrometer Class 2 GIE
§864.5400 Timer, Clot, Automated Class 2 GKN
§864.5400 Instrument, Coagulation, Automated Class 2 GKP
§864.5400 Timer, Coagulation Class 2 JBT
§864.5400 Instrument, Coagulation Class 2 KQG
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§864.7140 Activated Whole Blood Clotting Time Class 2 JBP
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7525 Assay, Heparin Class 2 KFF
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7925 Activated Partial Thromboplastin Class 2 GFO
§864.7925 Reagent, Thromboplastin And Control Class 2 GGO
§864.7925 Test, Time, Partial Thromboplastin Class 2 GGW
§864.7925 Reagent & Control, Partial Thromboplastin Time Class 2 GIT
Relevant FDA Guidance and/or Supportive Publications*
CLSI C3-A3 Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third Edition.

CLSI C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline - Second Edition.

CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition.

CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-based Coagulation Assays and Molecular Hemostasis Assays.

Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators, Issued February 1999.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Min Wu
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.