# K030058: Earlydetect Menopause Test for FSH

- Pathway: 510(k) (Traditional)
- Applicant: Early Detect, Inc.
- Decided: Jul 30, 2003 after 204 days
- Product code: CGJ (Radioimmunoassay, Follicle-Stimulating Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1300
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.

Source page: https://510kreport.com/device/K030058
Methodology: https://510kreport.com/methodology