510(k) Report

510(k) · Cleared

Cleared

Quantrx Female Fertility Test

K070484510(k) TraditionalCleared Oct 22, 2007244-day reviewClass I21 CFR 862.1300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quantrx Biomedical Corporation · NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter

Cleared on Oct 22, 2007 as substantially equivalent to K032002 (Genosis, Inc., 2003) and 2 other predicates after a 244-day review. Its family tree reaches back 2 generations to 1986.

Decided
Oct 22, 2007
Review
244 days
Class
Class I
Product code
NGA
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K862813 (1986). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1989: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK862813 · FSH Maiaclone Immunoradiometric Assay Kit · Serono Diagnostics, Inc. · 1986K032002 · Fertell Female Fertility Test · Genosis, Inc. · 200319851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors K032002 · Fertell Female Fertility Test · Genosis, Inc. · 2003K862813 · FSH Maiaclone Immunoradiometric Assay Kit · Serono Diagnostics, Inc. · 19860
  1. Root · 2 generations backK862813 FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc. · 1986
  2. 1 generation backK032002 Fertell Female Fertility TestGenosis, Inc. · 2003
  3. This deviceK070484 Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K862813FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc.1986—
−1K032002Fertell Female Fertility TestGenosis, Inc.2003—
0 (this device)K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199410
199510
200110
200410
FIG. 1 — Lineage of K070484, 1986–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K032002Fertell Female Fertility Test
Summary page 1
…Regulatory Classification: 21 CFR 862.1300 Class I, limitation of exemption exists [862.9 (c) (9)] Legally Marketed Predicate Devices: Fertell Female Fertility Test (k032002) Surestep FSH Menopause Test (k010556) FSH Menopause Predictor Test (k041165) DPC IRMA serum FSH (k893976) Pro…
Genosis, Inc.2003—
Kept off the family treeK010556Surestep 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
….1300 Class I, limitation of exemption exists [862.9 (c) (9)] Legally Marketed Predicate Devices: Fertell Female Fertility Test (k032002) Surestep FSH Menopause Test (k010556) FSH Menopause Predictor Test (k041165) DPC IRMA serum FSH (k893976) Product Description: The QuantRx Female F…
*K041165FSH Menopause Predictor Test
Summary page 1
…xists [862.9 (c) (9)] Legally Marketed Predicate Devices: Fertell Female Fertility Test (k032002) Surestep FSH Menopause Test (k010556) FSH Menopause Predictor Test (k041165) DPC IRMA serum FSH (k893976) Product Description: The QuantRx Female Fertility Test is a rapid, immunochromato…
ACON Laboratories, Inc.2004—
*K893976Coat-a-Count (TM) FSH Irma
Summary page 1
…Marketed Predicate Devices: Fertell Female Fertility Test (k032002) Surestep FSH Menopause Test (k010556) FSH Menopause Predictor Test (k041165) DPC IRMA serum FSH (k893976) Product Description: The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurem…
Diagnostic Products Corp.1989—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 17.1 years on median.
  • 1 of the 7 ancestors has a recall of any class.

How does its category compare?

All NGA devices

NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NGA

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGA

Too few NGA 510(k)s in any year since 2007 to give a median.

Recalls per year · NGA

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGA

No MAUDE report names NGA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Quantrx Biomedical Corporation

4 FDA decisions under this applicant name. See the company

  • K080436Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052Quantrx Biomedical Corporation · 2009
  • K080431Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054Quantrx Biomedical Corporation · 2009
  • K080455Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050Quantrx Biomedical Corporation · 2008

Recent decisions in NGA

The NGA category page

  • K032002Fertell Female Fertility TestGenosis, Inc. · 2003

https://510kreport.com/device/K070484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070484: Quantrx Female Fertility Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070484

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026