# K033658: E.P.T. Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Unipath, Ltd.
- Decided: Jan 16, 2004 after 56 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.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices 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.

## Most influential descendants
- K043443: One Step HCG Urine Pregnancy Test (2005), 14 descendants of its own
- K173229: Preview Digital Pregnancy Test (2018), 2 descendants of its own
- K222305: MissLan™ Digital Pregnancy Rapid Test (2022), 1 descendant of its own
- K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (2020), 1 descendant of its own
- K192123: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (2019), 1 descendant of its own

## 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/K033658
Methodology: https://510kreport.com/methodology