# K963002: Active Androstenedione Eia

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Aug 16, 1996 after 14 days
- Product code: CIZ (Radioimmunoassay, Androstenedione)
- Device class: 1
- Regulation: 21 CFR 862.1075
- 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) DSL 3800 Androstenedione RIA: named in the summary without a submission number

## Indications for use
The DSL Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.

Source page: https://510kreport.com/device/K963002
Methodology: https://510kreport.com/methodology