510(k) · Cleared
ClearedADVIA Centaur® Anti-Müllerian Hormone (AMH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · PQO Anti-Müllerian Hormone Test System
Cleared on Jun 2, 2023 as substantially equivalent to K170524 (Beckman Coulter, Inc., 2017) after a 346-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Jun 2, 2023
- Review
- 346 days
- Class
- Class II
- Product code
- PQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150057 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K223679 Access AMHscore 5.1 · 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 |
|---|---|---|---|
| * | K170524 | Access AMHSummary page 5…Toxicology Product Code PQO Regulation Number 21 CFR 862.1092 PREDICATE DEVICE Name of Device: Access AMH 510(k): K170524 ASSAY PRINCIPLE The ADVIA Centaur AMH assay is a sandwich immunoassay using direct acridinium ester-based chemiluminom… | 2017 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K170524.
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. 2023, 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?
The ADVIA Centaur® Anti‑Müllerian Hormone (AMH) assay is for in vitro diagnostic use in the quantitative determination of anti-Müllerian hormone (AMH) in human serum and plasma (lithium heparin) using the ADVIA Centaur® XP system. The measurement of AMH is used as an aid in the assessment of the ovarian reserve in women presenting to fertility clinics. This assay is intended to distinguish between women with AFC (antral follicle count) values > 15 (high…
Read the full statement (130 words)
The ADVIA Centaur® Anti‑Müllerian Hormone (AMH) assay is for in vitro diagnostic use in the quantitative determination of anti-Müllerian hormone (AMH) in human serum and plasma (lithium heparin) using the ADVIA Centaur® XP system.
The measurement of AMH is used as an aid in the assessment of the ovarian reserve in women presenting to fertility clinics. This assay is intended to distinguish between women with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve).
This assay is intended to be used in conjunction with other clinical and laboratory findings, such as AFC, before starting fertility therapy. This assay is not intended to be used for monitoring women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.
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/K221801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221801: ADVIA Centaur® Anti-Müllerian Hormone (AMH).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221801
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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