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Recognized Consensus Standards
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Recognition List Number: 022 Publication Date: 09/08/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-101: NCCLS H51-A, Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity. (InVitro Diagnostics)

Date of Standard: 2002. 
Address of Standards Organization:
  National Committee for Clinical Laboratory Standards (NCCLS)
  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 DEVICES FOR MEASURING VON WILLEBRAND FACTOR ANTIGEN IN PLASMA
IN VITRO DIAGNOSTIC DEVICES FOR MEASURING RISTOCETIN COFACTOR ACTIVITY AS A FUNCTION OF PLATELET AGGLUTINATION (AGGREGATION) IN PLASMA.
Processes Affected:
510(K), PMA, IDE, PDP
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§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
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.5700 Reagent, Platelet Aggregation Class 2 GHR
§864.5700 System, Automated Platelet Aggregation Class 2 JOZ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.6675 Aggregometer, Platelet, Photo-Optical Scanning Class 2 JBY
§864.6675 Aggregometer, Platelet, Thrombokinetogram Class 2 GKW
§864.6675 Aggregrometer, Platelet Class 2 JBX
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§864.7290 Plasma, Coagulation Factor Deficient Class 2 GJT
§864.7290 Test, Qualitative And Quantitative Factor Deficiency Class 2 GGP
 
Relevant Guidance:
Points to consider for collection of data in support in in-vitro devices submissions for 510(k) clearance
FDA Technical Contact:
  Yung Chan
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  Email: yung.chan@fda.hhs.gov
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