# K971725: Opus Progesterone

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 18, 1997 after 40 days
- Product code: JLS (Radioimmunoassay, Progesterone)
- Device class: 1
- Regulation: 21 CFR 862.1620
- 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. The FDA summary names its predicate without a number.
- (no number) DPC Coat-a-Count® Progesterone: named in the summary without a submission number

## Indications for use
OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers

Source page: https://510kreport.com/device/K971725
Methodology: https://510kreport.com/methodology