FDA product code JBF: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
JBF is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), screening. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under JBF, 1 in the last five years, from 5 different applicants. The average 510(k) review took 401 days (median 295). FDA has posted 1 recall for JBF devices.
Classification
| Field | Value |
|---|---|
| Device name | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening |
| Device class | Class II |
| Regulation | 21 CFR 864.7360 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 876 |
Compare with all 510(k) review times · Search every JBF clearance
Top JBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baebies, Inc. | 1 | 2022-09-14 |
| Alere Scarborough, Inc. | 1 | 2016-06-17 |
| Binax, Inc. | 1 | 2008-10-23 |
| Pointe Scientific, Inc., | 1 | 2003-03-31 |
| Sigma Diagnostics, Inc. | 1 | 1995-06-29 |
Most recent JBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201049 | Baebies, Inc. | FINDER G6PD | 2022-09-14 | 876 |
| K161364 | Alere Scarborough, Inc. | BinaxNOW G6PD Test | 2016-06-17 | 31 |
| K080003 | Binax, Inc. | BINAXNOW G6PD TEST | 2008-10-23 | 295 |
| K024006 | Pointe Scientific, Inc., | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | 2003-03-31 | 117 |
| K933934 | Sigma Diagnostics, Inc. | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | 1995-06-29 | 687 |
Recalls for JBF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-05-19.
Frequently asked questions
What is FDA product code JBF?
JBF is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), screening. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel.
What device class is JBF?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBF?
Across 5 cleared submissions the average was 401 days from receipt to decision (median 295).
Which companies have the most JBF clearances?
Baebies, Inc. (1); Alere Scarborough, Inc. (1); Binax, Inc. (1); Pointe Scientific, Inc., (1); Sigma Diagnostics, Inc. (1).
Have JBF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code JBF
- Run a recall and safety report across every JBF manufacturer
- Watch product code JBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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