# K991466: Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation Predictor (Cassette)

- Pathway: 510(k) (Traditional)
- Applicant: Selfcare, Inc.
- Decided: May 25, 1999 after 28 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 K894579 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981271: Clearplan Easy Ovulation Test, Unipath, Ltd. (1998) Summary page 1.
- K894579: Clearplan Easy, Unipath, Ltd. (1989) Summary page 1.

## Indications for use
The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.

Source page: https://510kreport.com/device/K991466
Methodology: https://510kreport.com/methodology