# K970424: Excel One Step Urine HCG Pregnancy Dipstick Test

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Mar 6, 1997 after 30 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 DipStick Test is Excel Scientific, Inc.'s name for professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.

Source page: https://510kreport.com/device/K970424
Methodology: https://510kreport.com/methodology