# K170524: Access AMH

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 13, 2017 after 264 days
- Product code: PQO (Anti-Müllerian Hormone Test System)
- Device class: 2
- Regulation: 21 CFR 862.1092
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150057 (2016). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150057: Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5, Roche Diagnostics (2016) Summary page 5.

## Most influential descendants
- K221801: ADVIA Centaur® Anti-Müllerian Hormone (AMH) (2023), 0 descendants of its own
- K223679: Access AMH (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K170524
Methodology: https://510kreport.com/methodology