Cleared Traditional

QUANTRX FEMALE FERTILITY TEST (K070484) - FDA 510(k) Clearance

Class I Chemistry device.

K070484 · Quantrx Biomedical Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
244d
Days
Class 1
Risk

K070484 is an FDA 510(k) clearance for the QUANTRX FEMALE FERTILITY TEST. Classified as Test, Follicle Stimulating Hormone (fsh), Over The Counter (product code NGA), Class I - General Controls.

Submitted by Quantrx Biomedical Corporation (San Diego, US). The FDA issued a Cleared decision on October 22, 2007 after a review of 244 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantrx Biomedical Corporation devices

Submission Details

510(k) Number K070484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date October 22, 2007
Days to Decision 244 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 88d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NGA Test, Follicle Stimulating Hormone (fsh), Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.