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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 011 Date of Entry 10/04/2004 
FR Recognition Number 7-105
CLSI  H30-A2
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
This document provides general guidelines for performing the fibrinogen assay in the clinical laboratory. It also includes reporting of results and in vivo and in vitro conditions that may alter results.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
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 Test, Fibrinogen Class 2 GIS
§864.7340 System, Fibrinogen Determination Class 2 KQJ
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

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

CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard-Sixth Edition.

CLSI H3-A4 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Fourth Edition.

CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays; Approved Guideline-Fifth Edition.

CLSI H47-A One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline.

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
 Iwona Fijalkowska
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.