Cleared Special

K043599 - MOMENTS MENOPAUSE CHECK, MODEL 9113 (FDA 510(k) Clearance)

Class I Chemistry device.

K043599 · Phamatech, Inc. · Chemistry device
Feb 2005
Decision
58d
Days
Class 1
Risk

K043599 is an FDA 510(k) clearance for the MOMENTS MENOPAUSE CHECK, MODEL 9113. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 K043599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date February 25, 2005
Days to Decision 58 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
176d faster than avg
Panel avg: 234d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
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.