# DEN150057: Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

- Pathway: De Novo (Direct)
- Applicant: Roche Diagnostics
- Decided: Dec 19, 2016 after 376 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170524: Access AMH (2017), 2 descendants of its own
- K221801: ADVIA Centaur® Anti-Müllerian Hormone (AMH) (2023), 0 descendants of its own
- K223679: Access AMH (2023), 0 descendants of its own
- K203757: Elecsys AMH (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN150057
Methodology: https://510kreport.com/methodology