| CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 7-221 |
| 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 document is a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. H01 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube assemblies.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.1675 | Tubes, Vacuum Sample, With Anticoagulant | Class 2 | GIM |
| §862.1675 | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | JKA |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |