FDA 510(k) · MFB Fertility
K191462: Proov Test (Mfb Fertility, Inc.)
Mfb Fertility, Inc. received FDA 510(k) K191462 for Proov Test, with a decision date of Feb 27, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K191462 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mfb Fertility, Inc. |
| Device name | Proov Test |
| Product code | QKE: Immunoassay, Pregnanediol Glucuronide, Over The Counter |
| Regulation (21 CFR) | 862.1620 |
| Device class | Class 1 |
| Date received | Jun 3, 2019 |
| Decision date | Feb 27, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.