Cleared Traditional

K030058 - EARLYDETECT MENOPAUSE TEST FOR FSH

K030058 is an FDA 510(k) clearance for EARLYDETECT MENOPAUSE TEST FOR FSH, manufactured by Early Detect, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K030058 · Early Detect, Inc. · Chemistry device
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Jul 2003
Decision
204d
Days
Class 1
Risk

K030058 is an FDA 510(k) clearance for the EARLYDETECT MENOPAUSE TEST FOR FSH. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Early Detect, Inc. (Orange, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Early Detect, Inc. devices

FDA 510(k) Submission Details - K030058

510(k) Number K030058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2003
Decision Date July 30, 2003
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
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 68
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K030058.
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