# K032992: Unimark Home Pregnancy Test Device

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Atlantic, Inc.
- Decided: Nov 21, 2003 after 57 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
Longest line of descent: 2 generations back to K941090 (1994). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941090: Unistep HCG Pregnancy Test Strip, Biotech Atlantic, Inc. (1994) Summary page 1.
- K960174: Unimark Midstream Pregnancy Test Stick, Biotech Atlantic, Inc. (1996) Summary page 1.

## 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
UniMark@Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin OCG) in urine. It is intended for consumer use at home. It is indicated for use in the early detection of pregnancy.

Source page: https://510kreport.com/device/K032992
Methodology: https://510kreport.com/methodology