# K131236: Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test,  Midstream Test and Dip/Card Strip

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Nov 7, 2013 after 190 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 K012215 (2001). 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)
- K012215: Quik-Check Home Pregnancy Test, ACON Laboratories, Inc. (2001) Summary page 1.

## Indications for use
UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K131236
Methodology: https://510kreport.com/methodology