| CLSI H51-A Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline. |
| Recognition Date | 2009-09-08 |
| Recognition List | 022 |
| Recognition Number | 7-101 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Lea Carrington FDA/OMPT/CDRH/OIR/DIHD/ 301-796-6164 lea.carrington@fda.hhs.gov |
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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.
| 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 |
| §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 |
| §864.5700 | Reagent, Platelet Aggregation | Class 2 | GHR |
| §864.5700 | System, Automated Platelet Aggregation | Class 2 | JOZ |
| §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 |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |