JMB · Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
Hematology · 21 CFR 864.7360 · Class 2
Overview
| Product Code | JMB |
|---|---|
| Device Name | Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase |
| Regulation | 21 CFR 864.7360 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850680 | ENCORE FERRITIN REAGENT | Hybritech, Inc. | Mar 21, 1985 | SESE |
Top Applicants
- Hybritech, Inc. — 1 clearance
