| CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 7-145 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Jacqueline Cleary FDA/OMPT/CDRH/OIR/DIHD/IMFB/ 240-402-0490 jacqueline.cleary@fda.hhs.gov |
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This standard was developed to address issues of procedures and quality assurance for clinical applications of flow cytometry. It is designed to aid clinical laboratorians in the development of quality assurance procedures and to establish the foundation for different laboratories using different commercially available instruments to obtain comparable results. Specific topics covered include: specimen collection, transport, and preparation; sample quality control and staining procedures; instrument calibration; sample analysis, and data analysis, storage, and reporting.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.5220 | Counter, Differential Cell | Class 2 | GKZ |
| Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, Issued December 2001. |