# K262299: Instant-View® hCG Combo II Cassette Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Sep 22, 2026 after 77 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 5.

## Indications for use
The Instant-View® hCG Combo II Cassette Test is a chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. It is for use as an aid in the early detection of pregnancy. This test is for health care professional use only and not for self-testing.

Source page: https://510kreport.com/device/K262299
Methodology: https://510kreport.com/methodology