Cleared Traditional

K032002 - FERTELL FEMALE FERTILITY TEST

K032002 is an FDA 510(k) clearance for FERTELL FEMALE FERTILITY TEST, manufactured by Genosis, Inc.. The device is a Class 1 Chemistry device with product code NGA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K032002 · Genosis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
125d
Days
Class 1
Risk

K032002 is an FDA 510(k) clearance for the FERTELL FEMALE FERTILITY TEST. Classified as Test, Follicle Stimulating Hormone (fsh), Over The Counter (product code NGA), Class I - General Controls.

Submitted by Genosis, Inc. (Washington, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 125 days - within the typical 510(k) review window.

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 Genosis, Inc. devices

FDA 510(k) Submission Details - K032002

510(k) Number K032002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date October 30, 2003
Days to Decision 125 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
37d slower than avg
Panel avg: 88d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

NGA Device Classification - Class 1, General Controls

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.