Cleared Traditional

K040575 - PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112

K040575 is an FDA 510(k) clearance for PHARMATECH MENOPAUSE CHECK, manufactured by Phamatech, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K040575 · Phamatech, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
77d
Days
Class 1
Risk

K040575 is an FDA 510(k) clearance for the PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112. 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 May 20, 2004 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040575

510(k) Number K040575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date May 20, 2004
Days to Decision 77 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

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 86
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K040575.
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FSH MENOPAUSE PREDICTOR TEST
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EARLYDETECT MENOPAUSE TEST FOR FSH
K030058 · Early Detect, Inc. · Jul 2003
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · Genua 1944, Inc. · Jan 2001
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · Monobind · Sep 1997
K040575 · PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
Download PDF FDA Summary Phamatech, Inc.