# K020799: Quickvue One-Step HCG-Urine

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: May 17, 2002 after 66 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- 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
- K102175: Rapidvue HCG Test (2010), 0 descendants of its own

## Recalls of this device
- Nov 23, 2010 · Not classified · Z-1457-2011: The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit

## Indications for use
The QuickVue One-Step hCG-Urine is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Source page: https://510kreport.com/device/K020799
Methodology: https://510kreport.com/methodology