510(k) · Cleared
ClearedLuminescent Immunoassay Kit for the Detection of Progesterone in Saliva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibl GmbH · JLS Radioimmunoassay, Progesterone
Cleared on Jul 22, 2004 after a 105-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 22, 2004
- Review
- 105 days
- Class
- Class I
- Product code
- JLS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040923 Luminescent Immunoassay Kit for the Detection of Progesterone in…Ibl GmbH · 2004
- Descendant · cites it directly · 0 of its ownK191462 Proov TestMfb Fertility, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191462Proov TestMfb Fertility, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva | Ibl GmbH | 2004 | — |
| +1 | K191462 | Proov Test | Mfb Fertility, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 JLS? 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191462 | Proov Test | 2020 | 0 |
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?
- Of its descendants, K191462 (Mfb Fertility, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JLS devicesJLS Radioimmunoassay, Progesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLS
FDA has decided no JLS device since 2007.
Median 510(k) review, days · JLS
Too few JLS 510(k)s in any year since 2007 to give a median.
Recalls per year · JLS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLS
3in 2025
MAUDE reports naming product code JLS, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 3 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 1 | 41 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.
The IBL SaliCap Set is used for the collection, handling, and storage of saliva used in the Progesterone LIA assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040923: Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040923
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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