# K963231: Excel Onestep Urine HCG Module Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Dec 4, 1996 after 107 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. The FDA summary names no predicate by number.

## Indications for use
Excel OneStep Urine hCG Pregnancy Module Test is Excel Scientific, Inc.'s name for the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.

Source page: https://510kreport.com/device/K963231
Methodology: https://510kreport.com/methodology