# K971286: EZ Sure (Excel) Urine Midstream Pregnancy Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: May 8, 1997 after 31 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) Syntron Quikpac II pregnancy test (BeSure Home Test): named in the summary without a submission number

## Indications for use
EZ¢ Sure™ (Excel) Urine Midstream Early Pregnancy Home Test is kxcel Scientific, inc.'s name for OTC use of solid phaso migratory chromatography immunoassay in vitro diagnostic tusl kit for the qualitetive dotection of human Chorionic Gonadatropin (hCG) in urine.

Source page: https://510kreport.com/device/K971286
Methodology: https://510kreport.com/methodology