# K970467: EZ Sure One Step Ovulation Predictor Home Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: Mar 18, 1997 after 39 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
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 its predicate without a number.
- (no number) Conceive® OneStep Ovulation Prediction Test: named in the summary without a submission number

## Indications for use
The EZySure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific, Inc.'s name for OTC use of a solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine.

Source page: https://510kreport.com/device/K970467
Methodology: https://510kreport.com/methodology