# K203272: Alltest Pregnancy Rapid Combo Test Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Jan 31, 2022 after 451 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: 2 generations back to K020801 (2002). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132834: Fastep S10 HCG Serum/Urine Combo Test, Polymed Therapeutics, Inc. (2014) Summary page 4.

## Most influential descendants
- K262299: Instant-View® hCG Combo II Cassette Test (2026), 0 descendants of its own
- K241919: Innovita HCG Pregnancy Rapid Combo Test (2024), 0 descendants of its own

## Indications for use
The Alltest Pregnancy Rapid Combo Test Cassette 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/K203272
Methodology: https://510kreport.com/methodology