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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 7-159: CLSI H21-A5, collection, transport, and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assays. (InVitro Diagnostics)

Date of Standard: 2008. 
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 CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(3)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
Devices Affected:
Hematology devices using blood specimens for coagulation testing.
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.5400 Fibrometer Class 2 GIE
§864.5425 Control, Plasma, Abnormal Class 2 GGC
§864.5425 Plasma, Coagulation Control Class 2 GGN
§864.5425 Plasma, Control, Normal Class 2 GIZ
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§864.5680 Analyzer, Heparin, Automated Class 2 JOX
§864.7060 Antigen, Antiserum, Control, Antithrombin Iii Class 2 DDQ
§864.7060 Antithrombin Iii Quantitation Class 2 JBQ
§864.7060 Antithrombin Iii, Two Stage Clotting Time Assay Class 2 JPE
§864.7290 Plasma, Coagulation Factor Deficient Class 2 GJT
§864.7290 Test, Qualitative And Quantitative Factor Deficiency Class 2 GGP
§864.7320 Fibrin Split Products Class 2 GHH
§864.7320 Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class 2 DAP
§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
§864.7875 Test, Thrombin Time Class 2 GJA
§864.7875 Thrombin Class 2 GJB
§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
§864.8950 Reagent, Russel Viper Venom Class 1 GIR
Relevant Guidance:
NCCLS:

C28-A2 - How to Define and Determine Reference Intervals in the Clinincal Laboratory; Approved Guideline - Second Edition (2000)
H1-A5 - Tubes and Additives for Venous Blood Specimen Collection; Approved Standard - Fifth Edition (2003)
H3-A5 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard - Fifth Edition (2003)
H47-A - One Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT Test); - Approved Guideline (1996)
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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