# K962580: EZ Sure Onestep Early Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Aug 29, 1996 after 59 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 its predicate without a number.
- (no number) BeSure OneStep Pregnancy Test: named in the summary without a submission number

## Indications for use
EZ?Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vifro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.

Source page: https://510kreport.com/device/K962580
Methodology: https://510kreport.com/methodology