# K970425: EZ Sure Urine Dipstick Pregnancy Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Mar 6, 1997 after 30 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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
EZ% Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC 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/K970425
Methodology: https://510kreport.com/methodology