# DEN180004: picoAMH ELISA

- Pathway: De Novo (Direct)
- Applicant: Ansh Labs, LLC
- Decided: Oct 24, 2018 after 275 days
- Product code: QDH (Menopause Test System)
- Device class: 2
- Regulation: 21 CFR 862.1093
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only.

Source page: https://510kreport.com/device/DEN180004
Methodology: https://510kreport.com/methodology