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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 7-112
CLSI POCT14-A (Formerly H49-A) Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
This document provides guidance to users and manufacturers of point-of-care coagulation devices for monitoring heparin and warfarin anticoagulant therapy, and to ensure reliable results comparable to those obtained by routine clinical laboratory testing.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5400 Fibrometer Class 2 GIE
§864.5400 Instrument, Coagulation Class 2 KQG
§864.5400 Instrument, Coagulation, Automated Class 2 GKP
§864.5400 Timer, Clot, Automated Class 2 GKN
§864.5400 Timer, Coagulation Class 2 JBT
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§864.7140 Activated Whole Blood Clotting Time Class 2 JBP
§864.7525 Assay, Heparin Class 2 KFF
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7925 Activated Partial Thromboplastin Class 2 GFO
§864.7925 Reagent & Control, Partial Thromboplastin Time Class 2 GIT
§864.7925 Reagent, Thromboplastin And Control Class 2 GGO
§864.7925 Test, Time, Partial Thromboplastin Class 2 GGW
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.
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.