# K041748: Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream)

- Pathway: 510(k) (Abbreviated)
- Applicant: Azog, Inc.
- Decided: Aug 9, 2004 after 41 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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: 1 generation back to K022680 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022680: Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick), Azog, Inc. (2002) Summary page 2.
- K022681: Azog, Inc. HCG One-Step Urine Pregnancy Test (Device or Cassette), Azog, Inc. (2002) Summary page 2.

## Indications for use
AZOG, Inc. hCG One-Step Urine Home Pregnancy Test (DipStick, Cassette and Midstream) are intended for the qualitative determination of Human Chrionic Gonadotropin (hCG) in Human Urine. The test is for Over-The-Counter and/or Professional Use. The test is for the early detection of pregnancy.

Source page: https://510kreport.com/device/K041748
Methodology: https://510kreport.com/methodology