21 CFR 864.7100 — Cell Enzymes (Erythrocytic And Leukocytic)
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7100
Identification
Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JBE | Cell Enzymes (Erythrocytic And Leukocytic) | 2 | 1 | 3rd Party |
| LKZ | Red-Cell Count By Photometry | 2 | 2 | 3rd Party |
