Cleared Special

K021409 - AT HOME OVULATION TEST, MODEL 9032 (FDA 510(k) Clearance)

Class I Chemistry device.

K021409 · Phamatech, Inc. · Chemistry device
May 2002
Decision
21d
Days
Class 1
Risk

K021409 is an FDA 510(k) clearance for the AT HOME OVULATION TEST, MODEL 9032. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on May 24, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K021409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date May 24, 2002
Days to Decision 21 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
213d faster than avg
Panel avg: 234d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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.