# K021409: AT Home Ovulation Test, Model 9032

- Pathway: 510(k) (Special)
- Applicant: Phamatech, Inc.
- Decided: May 24, 2002 after 21 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) Phamatech OvuCard: named in the summary without a submission number
- (no number) Quidel OvuQuick LH Test: named in the summary without a submission number

## Indications for use
The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. It is intended for over the counter use.

Source page: https://510kreport.com/device/K021409
Methodology: https://510kreport.com/methodology