510(k) · Cleared
ClearedElecsys AMH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · PQO Anti-Müllerian Hormone Test System
Cleared on Jun 10, 2022 as substantially equivalent to DEN150057 (Roche Diagnostics, 2016) after a 534-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Jun 10, 2022
- Review
- 534 days
- Class
- Class II
- Product code
- PQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150057 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150057 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5Roche Diagnostics · 2016
- This deviceK203757 Elecsys AMHRoche Diagnostics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016 | — |
| 0 (this device) | K203757 | Elecsys AMH | Roche Diagnostics | 2022 | — |
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 PQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PQO device
- #1 K221801 ADVIA Centaur® Anti-Müllerian Hormone (AMH)score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5Summary page 4…csys AMH Classification Name Clinical Chemistry Product Codes, PQO, 21 CFR 862.1092 Regulation Numbers Predicate Devices DEN150057, Elecsys AMH System Page 1 === P… | 2016 |
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.
- 1 other device also cites its predicate DEN150057.
How does its category compare?
All PQO devicesPQO Anti-Müllerian Hormone Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PQO
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PQO
Too few PQO 510(k)s in any year since 2007 to give a median.
Recalls per year · PQO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQO
1in 2025
MAUDE reports naming product code PQO, 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 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Elecsys AMH is intended for the in vitro quantitative determination of anti-Miillerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of the ovarian reserve in women presenting to fertility clinics. This immunoassay is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values < 15 (normal or diminished ovarian…
Read the full statement (132 words)
Elecsys AMH is intended for the in vitro quantitative determination of anti-Miillerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of the ovarian reserve in women presenting to fertility clinics. This immunoassay is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values < 15 (normal or diminished ovarian reserve). This immunoassay is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy. Elecsys AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
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/K203757 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203757: Elecsys AMH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203757
Report an extraction error
Are you the manufacturer?
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