# K203757: Elecsys AMH

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 10, 2022 after 534 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.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K203757
Methodology: https://510kreport.com/methodology