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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 022 Date of Entry 09/08/2009 
FR Recognition Number 7-101
Standard
CLSI H51-A Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline.
Scope/Abstract
This guideline describes: appropriate test specimens, reagents and materials, methods of platelet agglutination and ELISA, preparation of reference curves, determination of reference intervals, quality control procedures, result interpretation, and sources of error for assays of von Willebrand factor antigen and ristocetin cofactor activity. A brief description of von Willebrand disease and its various subtypes is included, as well as a list of references to more comprehensive reviews of this commonly inherited and rarely acquired bleeding disorder.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
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
§864.5700 Reagent, Platelet Aggregation Class 2 GHR
§864.5700 System, Automated Platelet Aggregation Class 2 JOZ
§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
§864.7290 Plasma, Coagulation Factor Deficient Class 2 GJT
§864.7290 Test, Qualitative And Quantitative Factor Deficiency Class 2 GGP
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.
FDA Technical Contact
 Lea Carrington
  FDA/OC/CDRH/OPEQ/OIDRH/DIHD/
  301-796-6164
  lea.carrington@fda.hhs.gov
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.
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