# K013194: Unimark HCG Combo Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Biotech Atlantic, Inc.
- Decided: Oct 10, 2001 after 15 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only. It is indicated for use in the early detection of pregnancy.

Source page: https://510kreport.com/device/K013194
Methodology: https://510kreport.com/methodology