510(k) · Cleared
ClearedProov Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mfb Fertility, Inc. · QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter
Cleared on Feb 27, 2020 as substantially equivalent to K040923 (Ibl GmbH, 2004) after a 269-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Feb 27, 2020
- Review
- 269 days
- Class
- Class I
- Product code
- QKE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040923 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040923 Luminescent Immunoassay Kit for the Detection of Progesterone in…Ibl GmbH · 2004
- This deviceK191462 Proov TestMfb Fertility, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva | Ibl GmbH | 2004 | — |
| 0 (this device) | K191462 | Proov Test | Mfb Fertility, Inc. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaSummary page 4…n: 21 CFR §862.1620 Regulatory Class: Class I Classification Code: QKE IV. Predicate Device 510(k) Number: K040923 Device Name: IBL Progesterone LIA Test Manufacturer: IBL GMBH V. Device Description… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QKE devicesQKE Immunoassay, Pregnanediol Glucuronide, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QKE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QKE
Too few QKE 510(k)s in any year since 2007 to give a median.
Recalls per year · QKE
No recall names QKE since 2007.
Adverse event reports per year · QKE
3in 2021
MAUDE reports naming product code QKE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191462: Proov Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026