# K241919: Innovita HCG Pregnancy Rapid Combo Test

- Pathway: 510(k) (Traditional)
- Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.
- Decided: Aug 2, 2024 after 32 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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: 3 generations back to K020801 (2002). 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)
- K203272: Alltest Pregnancy Rapid Combo Test Cassette, Hangzhou AllTest Biotech Co., Ltd. (2022) Summary page 4.

## Indications for use
Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Source page: https://510kreport.com/device/K241919
Methodology: https://510kreport.com/methodology