# K960174: Unimark Midstream Pregnancy Test Stick

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Atlantic, Inc.
- Decided: Apr 1, 1996 after 76 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: 1 generation back to K941090 (1994). 1 ancestor in all.
16 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.

## Most influential descendants
- K032992: Unimark Home Pregnancy Test Device (2003), 15 descendants of its own
- 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

## Indications for use
The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy.

Source page: https://510kreport.com/device/K960174
Methodology: https://510kreport.com/methodology