# K040923: Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva

- Pathway: 510(k) (Traditional)
- Applicant: Ibl GmbH
- Decided: Jul 22, 2004 after 105 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191462: Proov Test (2020), 0 descendants of its own

## Indications for use
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation. The IBL SaliCap Set is used for the collection, handling, and storage of saliva used in the Progesterone LIA assay.

Source page: https://510kreport.com/device/K040923
Methodology: https://510kreport.com/methodology