# K070484: Quantrx Female Fertility Test

- Pathway: 510(k) (Traditional)
- Applicant: Quantrx Biomedical Corporation
- Decided: Oct 22, 2007 after 244 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: 2 generations back to K862813 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032002: Fertell Female Fertility Test, Genosis, Inc. (2003) Summary page 1.
- K041165: FSH Menopause Predictor Test, ACON Laboratories, Inc. (2004) Summary page 1.
- K893976: Coat-a-Count (TM) FSH Irma, Diagnostic Products Corp. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- 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.

## Indications for use
The QuantRxTM Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women attempting to conceive.

Source page: https://510kreport.com/device/K070484
Methodology: https://510kreport.com/methodology