# K974009: PS-Unit Cassette/Serum and Urine Combo HCG

- Pathway: 510(k) (Traditional)
- Applicant: International Newtech Development, Inc.
- Decided: Mar 13, 1998 after 143 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
PS - UNIT CASSETTE/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used.

Source page: https://510kreport.com/device/K974009
Methodology: https://510kreport.com/methodology