# K974721: Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Mar 3, 1998 after 75 days
- Product code: CGI (Radioimmunoassay, Estriol)
- Device class: 1
- Regulation: 21 CFR 862.1265
- 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) Diagnostic Products Corporation Coat-a-Count Free Estriol RIA method: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE3) in human serum on the Bayer Immuno 1™ system. Measurements of uE3 are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K974721
Methodology: https://510kreport.com/methodology