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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 013 FR Publication Date: 10/31/2005 

Part B: Supplementary Information

Recognition Number 7-112: CLSI H49-A, point-of-care monitoring of anticoagulation therapy; approved guideline. (InVitro Diagnostics)

Date of Standard: 2004. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In Vitro diagnostic POC/POL devices for the measurement of Prothrombin Time, Activated Partial Thrombinplastin Time, Activated Whole Blood Clotting Time tests, and Heparin.
Processes Affected:
510(k), PDP, IDE, HDE, PMA
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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 Guidance:
NCCLS C3-A3, Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline-Third Edition (1997)

NCCLS C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline-Second Edition (2000)

NCCLS H1-A4, Evacuated Tubes and Additives for Blood Specimen Collection-Fourth Edition, Approved Standard (1996)

NCCLS H3-A4, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Fourth Edition (1998)

NCCLS H21-A3, Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays; Approved Guideline-Third Edition (1998)

NCCLS M29-A, Protection of Laboratory Workers from Instrument biohazards and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue; Approved Guideline (1997)

FDA Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance

Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
FDA Technical Contact:
 Lan Nguyen
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4228
  Silver Spring MD 20993
  301/796-6178
  email: lan.nguyen@fda.hhs.gov
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