# K965084: Vidas Proesterone (PRG) (30 409)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jan 9, 1997 after 21 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 assay: named in the summary without a submission number

## Indications for use
The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantitative determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for use as an aid in the diagnosis and treatment of disorders of the ovaries and placenta.

Source page: https://510kreport.com/device/K965084
Methodology: https://510kreport.com/methodology