# K981443: Biosign HCG I - One Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jun 25, 1998 after 64 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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
Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy.

Source page: https://510kreport.com/device/K981443
Methodology: https://510kreport.com/methodology