# 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

- Pathway: 510(k) (Special)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Apr 5, 2022 after 120 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 K071930 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132085: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream, Co-Innovation Biotech Co., Ltd. (2013) Summary page 4.

## Indications for use
The Co-Innovation One Step Human Chorionic Gonadotropin (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 for over-the-counter (OTC) use. The Co-Innovation One Step Human Chorionic Gonadotropin (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 Human Chorionic Gonadotropin (HCG) Test Midstream 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.

Source page: https://510kreport.com/device/K213808
Methodology: https://510kreport.com/methodology