CLSI H62

Validation of Assays Performed by Flow Cytometry

Body

CLSI

Number

CLSI H62

FDA recognition no.

7-320

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Chapter 1: Subchapter 1.3.1 Definitions Chapter 3: Subchapter 3.1.1 Bioanalytical Data Categories Chapter 3: Subchapter 3.2 Application of Standard Validation Parameters for Flow Cytometric Methods Chapter 3: Subchapter 3.2.2 Linearity Chapter 3: Subchapter 3.3 Validation: Definition of Risk Chapter 4: Subchapter 4.2.5 Carryover Chapter 5: Subchapter 5.3.2 Assay Sensitivity including Table 13 Chapter 6: Subchapter 6.1.1.1 Acceptance Criteria Chapter 6: Subchapter 6.1.2.1 Accuracy Chapter 6: Subchapter 6.1.2.3 Detection Capability Chapter 6: Subchapters 6.1.2.6.1 Specimen Stability Chapter 6: Subchapter 6.1.2.7 Assay Carryover Chapter 6: Subchapter 6.1.3.2 Accuracy/Diagnostic Concordance Chapter 6: Subchapter 6.1.3.8 Assay Carryover (Instrument) Appendix A: Tables A1 - A8 Appendix G

Scope source: FDA 认可共识标准库

Laboratories covering this standard