JBL · Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Hematology · 21 CFR 864.7360 · Class 2
Overview
| Product Code | JBL |
|---|---|
| Device Name | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative |
| 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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | Astoria-Pacific, Inc. | May 11, 1999 | SESE |
| K790211 | DEHYDROGENOSE, GLUCOSE PHOSPHATE | Sigma Chemical Co. | Mar 15, 1979 | SESE |
Top Applicants
- Astoria-Pacific, Inc. — 1 clearance
- Sigma Chemical Co. — 1 clearance
