# K102175: Rapidvue HCG Test

- Pathway: 510(k) (Special)
- Applicant: Quidel Corporation
- Decided: Aug 25, 2010 after 23 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: 1 generation back to K020799 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020799: Quickvue One-Step HCG-Urine, Quidel Corp. (2002) Summary page 1.

## Indications for use
The RapidVue hCG test is an 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/K102175
Methodology: https://510kreport.com/methodology