# K972606: Pregnacol Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Aug 29, 1997 after 49 days
- Product code: JHJ (Agglutination Method, Human Chorionic Gonadotropin)
- 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 PREGNACOL PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.

Source page: https://510kreport.com/device/K972606
Methodology: https://510kreport.com/methodology