# K132085: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Nov 12, 2013 after 130 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 K071930 (2007). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071930: One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C, Blue Cross Bio-Medical Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K213808: Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream (2022), 0 descendants of its own
- K183097: Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream (2019), 0 descendants of its own

## Indications for use
The Co-Innovation One Step HCG Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended far over-the-counter (OTC) use. The Co-Innovation One Step HCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use. The Co-Innovation One Step HCG Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the mapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use .

Source page: https://510kreport.com/device/K132085
Methodology: https://510kreport.com/methodology