510(k) · Cleared
ClearedProgesterone Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kmi Diagnostics, Inc. · JLS Radioimmunoassay, Progesterone
Cleared on Nov 13, 1997 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 13, 1997
- Review
- 30 days
- Class
- Class I
- Product code
- JLS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973898: Progesterone Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973898
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026