Cleared Special

K043599 - MOMENTS MENOPAUSE CHECK, MODEL 9113

K043599 is an FDA 510(k) clearance for MOMENTS MENOPAUSE CHECK, manufactured by Phamatech, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Special 510(k) pathway after a 58-day FDA review.

K043599 · Phamatech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Phamatech, Inc. devices

FDA 510(k) Submission Details - K043599

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

CGJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 68
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K043599.
FSH MENOPAUSE PREDICTOR TEST
K041165 · ACON Laboratories, Inc. · Jun 2004
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · Monobind · Sep 1997
SEALITE SCIENCES AQUALITE FSH
K970085 · Sealite Sciences, Inc. · Feb 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996