# K960233: Miniclinic Ovulation Predictor

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Biomedical Corp.
- Decided: Apr 23, 1996 after 97 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) Conceive® Ovulation Predictor: named in the summary without a submission number
- (no number) Clearplan Easy One Step Ovulation Predictor: named in the summary without a submission number

## Most influential descendants
- K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15 (2000), 0 descendants of its own

## Indications for use
The MiniClinic Ovulation Predictor is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Luteinizing Hormone (hLH) in urine. This test is used to detect the mid-cycle LH surge which occurs approximately 24 hours prior to ovulation. By predicting ovulation, conception can be planned most effectively. Its intended use is identical to that of several over-the-counter (OTC) products currently available for home use.

Source page: https://510kreport.com/device/K960233
Methodology: https://510kreport.com/methodology