# K972748: Cards Q.S. HCG-Urine; and Concise Performance Plus HCG-Urine

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Aug 29, 1997 after 37 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. The FDA summary names no predicate by number.

## Indications for use
The CARDS® Q.S.® hCG-Urine (also sold under the brand name Concise® Performance Plus™ 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/K972748
Methodology: https://510kreport.com/methodology