# K050930: E.P.T. Certainty Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Unipath, Ltd.
- Decided: May 12, 2005 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
e.p.t CertaintyTm Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.

Source page: https://510kreport.com/device/K050930
Methodology: https://510kreport.com/methodology