# K191462: Proov Test

- Pathway: 510(k) (Traditional)
- Applicant: Mfb Fertility, Inc.
- Decided: Feb 27, 2020 after 269 days
- Product code: QKE (Immunoassay, Pregnanediol Glucuronide, Over The Counter)
- Device class: 1
- Regulation: 21 CFR 862.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040923 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040923: Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva, Ibl GmbH (2004) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K191462
Methodology: https://510kreport.com/methodology