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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 011 FR Publication Date: 09/01/2004 

Part B: Supplementary Information

Recognition Number 7-105: NCCLS H30-A2, procedure for the determination of fibrinogen in plasma; approved guideline second edition. (InVitro Diagnostics)

Date of Standard: 2001. 
Address of Standards Development Organization:
 National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
IN VITRO DIAGNOSTIC DEVICES FOR THE MEASUREMENT OF FIBRINOGEN IN CITRATED PLASMA.
Processes Affected:
510(K), PDP, IDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.7340 Fibrinogen Standard Class 2 GFX
§864.7340 Plasma, Fibrinogen Control Class 2 GIL
§864.7340 System, Fibrinogen Determination Class 2 KQJ
§864.7340 Test, Fibrinogen Class 2 GIS
Relevant Guidance:
NCCLS C3-A3, Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third Edition (1997)
C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline-Second Edition (2000)
H1-A4, Evacuated Tubes and Additives for Blood Specimen Collection-Fourth Edition, Approved Standard (1996)
H3-A4, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Fourth Edition (1998)
H21-A3, Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays; Approved Guideline-Third Edition (1998)
H47-A, One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996)
H48-A, Determination of Factor Coagulant Activities; Approved Guideline (1997)
M29-A, Protection of Laboratory Workers from Instruments bioharzards 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 Diagnostic Calibrators
FDA Technical Contact:
 Iwona Fijalkowska
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5213
  Silver Spring MD 20993
  301/796-6205
  email: iwona.fijalkowska@fda.hhs.gov
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