# K022680: Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)

- Pathway: 510(k) (Traditional)
- Applicant: Azog, Inc.
- Decided: Nov 1, 2002 after 81 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041748: Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream) (2004), 0 descendants of its own

## Indications for use
The AZOG 1CG One-Step (Urine) Pregnancy Test Strip (Dipstick) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K022680
Methodology: https://510kreport.com/methodology