JBF · Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Hematology · 21 CFR 864.7360 · Class 2
Overview
| Product Code | JBF |
|---|---|
| Device Name | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201049 | FINDER G6PD | Baebies, Inc. | Sep 14, 2022 | SESE |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | Jun 17, 2016 | SESE |
| K080003 | BINAXNOW G6PD TEST | Binax, Inc. | Oct 23, 2008 | SESE |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | Mar 31, 2003 | SESE |
| K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | Sigma Diagnostics, Inc. | Jun 29, 1995 | SESE |
Top Applicants
- Alere Scarborough, Inc. — 1 clearance
- Baebies, Inc. — 1 clearance
- Binax, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
