Cleared Traditional

PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575) - FDA 510(k) Clearance

Class I Chemistry device.

K040575 · Phamatech, Inc. · Chemistry device
Download Printable Device Report (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.

View all Phamatech, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 87
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K040575.
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · Abbott Laboratories · Jun 1994
COBAS CORE FSH EIA
K930304 · Roche Diagnostic Systems, Inc. · Sep 1993
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
ENZYMUN TEST(R) FSH
K900763 · Boehringer Mannheim Corp. · Mar 1990
MILENIA(TM) FSH (MKFS1,5)
K895005 · Diagnostic Products Corp. · Oct 1989