# K041165: FSH Menopause Predictor Test

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jun 17, 2004 after 44 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.
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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023408: InstaCheck® FSH Menopause Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K070484: Quantrx Female Fertility Test (2007), 0 descendants of its own

## Indications for use
FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulate Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.

Source page: https://510kreport.com/device/K041165
Methodology: https://510kreport.com/methodology