# K012252: Quik-Check Ovulation Predictor

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 24, 2001 after 37 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 K981207 (1998). 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)
- K981207: Clearplan Easy Fertility Monitor, Unipath, Ltd. (1998) Summary page 1.

## Indications for use
The QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.

Source page: https://510kreport.com/device/K012252
Methodology: https://510kreport.com/methodology