510(k) · Cleared
ClearedLuminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibl GmbH · CHP Radioimmunoassay, Estradiol
Cleared on Sep 24, 2004 after a 127-day review. The FDA summary names no predicate by number.
- Decided
- Sep 24, 2004
- Review
- 127 days
- Class
- Class I
- Product code
- CHP
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 CHP? 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?
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 CHP devicesCHP Radioimmunoassay, Estradiol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHP
FDA has decided no CHP device since 2007.
Median 510(k) review, days · CHP
Too few CHP 510(k)s in any year since 2007 to give a median.
Recalls per year · CHP
7in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHP
84in 2025
MAUDE reports naming product code CHP, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 1 | 29 |
| 2017 | 0 | — | 1 | 39 |
| 2018 | 0 | — | 1 | 38 |
| 2019 | 0 | — | 0 | 36 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 7 | 61 |
| 2023 | 0 | — | 0 | 60 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 0 | — | 0 | 84 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of
active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements
obtained by this device may be used in the diagnosis and treatment of various
hormonal sexual disorders and can be used to evaluate ovarian function. This test is
not intended for assessing placental function in complicated pregnancy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041349 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041349: Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041349
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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