# K955353: One Step Pregnancy HCG Serun Diluent Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Tcpi, Inc.
- Decided: Mar 19, 1996 after 119 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
Longest line of descent: 1 generation back to K934830 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934830: HCG Pregnancy One Step Test Strip, Tcpi, Inc. (1993) Summary page 1.

## Indications for use
The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum.

Source page: https://510kreport.com/device/K955353
Methodology: https://510kreport.com/methodology