| CLSI GP42-A6 (Formerly H04-A6) Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard -- Sixth Edition |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 7-203 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Yung Chan FDA/OMPT/CDRH/OIR/DCTD/ 301-796-6138 yung.chan@fda.hhs.gov |
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This standard provides a technique for the collection of diagnostic capillary blood specimens, including recommendations for collection sites and specimen handling and identification. Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens are also included.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.5425 | System, Multipurpose For In Vitro Coagulation Studies | Class 2 | JPA |
| §862.1675 | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | JKA |
| §862.1345 | Copper Reduction, Glucose | Class 2 | CFW |
| §862.1345 | Drink, Glucose Tolerance | Class 2 | MRV |
| §862.1345 | Ferricyanide, Glucose | Class 2 | CGD |
| §862.1345 | Glucose Dehydrogenase, Glucose | Class 2 | LFR |
| §862.1345 | Glucose Oxidase, Glucose | Class 2 | CGA |
| §862.1345 | Hexokinase, Glucose | Class 2 | CFR |
| §862.1345 | Orthotoluidine, Glucose | Class 2 | CGE |
| §862.1345 | System, Test, Blood Glucose, Over The Counter | Class 2 | NBW |
| §862.1225 | Alkaline Picrate, Colorimetry, Creatinine | Class 2 | CGX |
| §862.1225 | Electrode, Ion Based, Enzymatic, Creatinine | Class 2 | CGL |
| §862.1225 | Enzymatic Method, Creatinine | Class 2 | JFY |
| §862.1225 | Test, Creatinine, Over The Counter | Class 2 | NFZ |
| §862.1225 | Test, Cystatin C | Class 2 | NDY |
| There is no relevant guidance developed at this time. |