# K192843: INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

- Pathway: 510(k) (Traditional)
- Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
- Decided: Nov 22, 2019 after 50 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: 4 generations back to K941090 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043443: One Step HCG Urine Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2005) Summary page 4.

## Indications for use
The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

Source page: https://510kreport.com/device/K192843
Methodology: https://510kreport.com/methodology