FDA product code QKE: Immunoassay, Pregnanediol Glucuronide, Over The Counter
QKE is the FDA product code for immunoassay, pregnanediol glucuronide, over the counter. It is a Class I device, regulated under 21 CFR 862.1620 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under QKE. The average 510(k) review took 269 days (median 269).
Definition
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1620 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QKE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 269 |
Compare with all 510(k) review times · Search every QKE clearance
Top QKE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mfb Fertility, Inc. | 1 | 2020-02-27 |
Most recent QKE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191462 | Mfb Fertility, Inc. | Proov Test | 2020-02-27 | 269 |
Recalls for QKE devices
openFDA lists no recalls for product code QKE.
Frequently asked questions
What is FDA product code QKE?
QKE is the FDA product code for immunoassay, pregnanediol glucuronide, over the counter. It is a Class I device, regulated under 21 CFR 862.1620 and reviewed by the Clinical Toxicology panel.
What device class is QKE?
Class I, regulation 21 CFR 862.1620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QKE?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most QKE clearances?
Mfb Fertility, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKE
- Run a recall and safety report across every QKE manufacturer
- Watch product code QKE 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times