# K040329: Modification to E.P.T. Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Unipath, Ltd.
- Decided: Mar 8, 2004 after 26 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.® 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 first day of missed period and thereafter, but can also be used from four days before the expected period.

Source page: https://510kreport.com/device/K040329
Methodology: https://510kreport.com/methodology