CLSI POCT14-A (Formerly H49-A)

Standard Organization:

CLSI POCT14-A (Formerly H49-A)
Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

Recognition Date2014-07-09
Recognition List036
Recognition Number7-112
Extent Complete standard
Standards Orgs CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG InVitro Diagnostics
FDA Tech  Iwona Fijalkowska   FDA/OMPT/CDRH/OIR/DIHD/HEMB/   301-796-6205   iwona.fijalkowska@fda.hhs.gov

Rationale:

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Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§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
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7525 Assay, Heparin Class 2 KFF
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7140 Activated Whole Blood Clotting Time Class 2 JBP
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§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

FDA Guidance:

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.

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