# K973858: Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Nov 26, 1997 after 48 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (2016), 1 descendant of its own
- K250117: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (2025), 0 descendants of its own
- K131166: Sofia (R) HCG Fia (2013), 0 descendants of its own

## Indications for use
The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ hCG-Combo) is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Source page: https://510kreport.com/device/K973858
Methodology: https://510kreport.com/methodology