# K032002: Fertell Female Fertility Test

- Pathway: 510(k) (Traditional)
- Applicant: Genosis, Inc.
- Decided: Oct 30, 2003 after 125 days
- Product code: NGA (Test, Follicle Stimulating Hormone (Fsh), Over The Counter)
- 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
Longest line of descent: 1 generation back to K862813 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002450: Genua Menopause Monitor Test Kit, Genua 1944, Inc. (2001) Summary page 1.
- K935612: Axsym Follicle Stimulating Hormone (FSH), Abbott Laboratories (1994) Summary page 1.
- K862813: FSH Maiaclone Immunoradiometric Assay Kit, Serono Diagnostics, Inc. (1986) Summary page 1.
- K953581: First Response Ovulation Predictor Test, Armkel, LLC (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K023408: Instacheck Menopause Predictor 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.
- K010556: Surestep 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
The Fertell Female Fertility Test is intended to measure Follicle Stimulating Hormone (“FSH’) in urine as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.

Source page: https://510kreport.com/device/K032002
Methodology: https://510kreport.com/methodology