# K021386: Poly Stat HCG Dipstick Test

- Pathway: 510(k) (Traditional)
- Applicant: Alidex, Inc.
- Decided: Aug 5, 2002 after 95 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

Source page: https://510kreport.com/device/K021386
Methodology: https://510kreport.com/methodology