| CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 7-213 |
| 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 considers multiple variables that are involved in handling and processing blood specimens. Its application should enable the user to recognize and control accuracy and precision factors that occur between the time of blood collection and the time of test performance.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.3250 | Container, Specimen Mailer And Storage, Sterile | Class 1 | KDT |
| §864.3250 | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | Class 1 | KDW |
| §864.3250 | Container, Specimen, Sterile | Class 1 | FMH |
| §862.1675 | Tray, Blood Collection | Class 2 | GJE |
| §862.1675 | Tubes, Vacuum Sample, With Anticoagulant | Class 2 | GIM |
| §862.1675 | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | JKA |
| There is no relevant guidance developed at this time. |