21 CFR 864.7360 — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7360
Identification
An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 2 | 5 | 3rd Party |
| JBG | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot | 2 | 0 | 3rd Party |
| JBH | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod | 2 | 0 | 3rd Party |
| JBI | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition | 2 | 0 | 3rd Party |
| JBJ | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction | 2 | 0 | 3rd Party |
| JBK | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic | 2 | 0 | 3rd Party |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | 2 | 2 | 3rd Party |
| JBM | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis | 2 | 0 | 3rd Party |
| JLM | Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase | 2 | 1 | 3rd Party |
| JMB | Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase | 2 | 1 | 3rd Party |
| JMC | Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase | 2 | 0 | 3rd Party |
| KQE | Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase | 2 | 1 | 3rd Party |
