De Novo · Granted
GrantedElecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
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
Granted on Dec 19, 2016 as a new device type through De Novo after a 376-day review. 4 later devices descend from it.
- Decided
- Dec 19, 2016
- Review
- 376 days
- Class
- Class II
- Product code
- PQO
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN150057 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5Roche Diagnostics · 2016
- Descendant · cites it directly · 2 of its ownK170524 Access AMHBeckman Coulter, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK221801 ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK223679 Access AMHBeckman Coulter, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK203757 Elecsys AMHRoche Diagnostics · 2022
Most influential descendants
Showing 4 of 4 · See all- K170524Access AMHBeckman Coulter, Inc. · 2017 · cites it directly2descendants
- K221801ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K223679Access AMHBeckman Coulter, Inc. · 2023 · 2 generations on0descendants
- K203757Elecsys AMHRoche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016 | — |
| +1 | K170524 | Access AMH | Beckman Coulter, Inc. | 2017 | — |
| +2 | K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K223679 | Access AMH | Beckman Coulter, Inc. | 2023 | — |
| +1 | K203757 | Elecsys AMH | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K170524 (Beckman Coulter, Inc., 2017) has gone furthest, with 2 descendants of its own.
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. 2016, 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 system, consisting of the Elecsys AMH assay, AMH CalSet, PreciControl AMH, and AMH CalCheck 5, is intended for use in the in vitro quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count)…
Read the full statement (199 words)
Elecsys AMH system, consisting of the Elecsys AMH assay, AMH CalSet, PreciControl AMH, and AMH CalCheck 5, is intended for use in the in vitro quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of ovarian reserve in women presenting to fertility clinics. This system 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 system is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy. The Elecsys AMH system is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
The Elecsys AMH system is intended for use on cobas e 411 analyzer.
AMH CalSet is used for calibrating the quantitative Elecsys AMH assay.
PreciControl AMH is used for quality control of the Elecsys AMH assay.
AMH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established for the Elecsys AMH assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150057 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150057: Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150057
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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