510(k) · Cleared

Cleared

Access AMH

K223679510(k) TraditionalCleared Feb 3, 202357-day reviewClass II21 CFR 862.1092

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Coulter, Inc. · PQO Anti-Müllerian Hormone Test System

Cleared on Feb 3, 2023 as substantially equivalent to K170524 (Beckman Coulter, Inc., 2017) after a 57-day review. Its family tree reaches back 2 generations to 2016.

Decided: Feb 3, 2023
Review: 57 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.

By dateBy generation

Root · 2 generations backDEN150057 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5Roche Diagnostics · 2016
1 generation backK170524 Access AMHBeckman Coulter, Inc. · 2017
This deviceK223679 Access AMHBeckman Coulter, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN150057	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	Roche Diagnostics	2016	—
−1	K170524	Access AMH	Beckman Coulter, Inc.	2017	—
0 (this device)	K223679	Access AMH	Beckman Coulter, Inc.	2023	—

FIG. 1 — Lineage of K223679, 2016–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K170524	Access AMH Summary page 4 …ccess AMH Classification Name: Anti-Müllerian hormone test system Classification Regulation: (21 CFR 862.1092) Predicate Device: Device Name: Access AMH 510(k) Numbers: k170524 Device Description The Access Anti-Mullerian Hormone Assay, Access Anti-Mullerian Hormone Calibrators, and the A…	Beckman Coulter, Inc.	2017	—

Also cleared against K170524: 1 other device →

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 2 companies; a new generation was cleared every 5.2 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 devices

PQO 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

2007high 2 (2023) · low 0 (2007)2026

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

2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PQO

1in 2025

2007high 4 (2019) · low 0 (2007)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?

Read the full statement (126 words)

The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in 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). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223679 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223679: Access AMH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223679

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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