# K022829: Instant-View LH Ovulation Predicting Test

- Pathway: 510(k) (Abbreviated)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Nov 5, 2002 after 71 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 K981271 (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)
- K981271: Clearplan Easy Ovulation Test, Unipath, Ltd. (1998) Summary page 1.

## Indications for use
The Instant-View TM LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. It is for health care professional use, including at the point of care (physician’s office labs, doctor’s offices) .

Source page: https://510kreport.com/device/K022829
Methodology: https://510kreport.com/methodology