# K012215: Quik-Check Home Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 7, 2001 after 22 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
No predicates in its family tree.
3 later devices descend from it; 3 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
- K210341: One Step Pregnancy Test (2022), 0 descendants of its own
- K131236: Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test,  Midstream Test and Dip/Card Strip (2013), 0 descendants of its own
- K032661: Acon Quick-Check II Home Pregnancy Test Device (Cassette) (2003), 0 descendants of its own

## Indications for use
Quik-Check™ Home Pregnancy is intended for non-professional/Over-The Counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K012215
Methodology: https://510kreport.com/methodology