# K112449: Quikresponse One Step Midstream Early Pregrancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Sep 24, 2012 after 396 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 K992232 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030258: First Response Pregnancy Test, Armkel, LLC (2003) Summary page 2.

## Indications for use
QuikResponse'm One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.

Source page: https://510kreport.com/device/K112449
Methodology: https://510kreport.com/methodology