# K973208: First Sign

- Pathway: 510(k) (Traditional)
- Applicant: Texas Immunology, Inc.
- Decided: Oct 20, 1997 after 54 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Texae Immunology FIRST SIGN test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine vith a hCG Cut-off of 25 mIU/ml and is an aid in the esrly detection of pregnancy. This test is for over-the-counter and/or professional use.

Source page: https://510kreport.com/device/K973208
Methodology: https://510kreport.com/methodology