Cleared Traditional

K930304 - COBAS CORE FSH EIA

K930304 is an FDA 510(k) clearance for COBAS CORE FSH EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K930304 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1993
Decision
243d
Days
Class 1
Risk

K930304 is an FDA 510(k) clearance for the COBAS CORE FSH EIA. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 21, 1993 after a review of 243 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K930304

510(k) Number K930304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date September 21, 1993
Days to Decision 243 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
155d slower than avg
Panel avg: 88d · This submission: 243d
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 67
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K930304.
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
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K935612 · Abbott Laboratories · Jun 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005 · Bio-Rad Laboratories, Inc. · Mar 1994
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746 · Biomerieux Vitek, Inc. · Jun 1992
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · Medix Biotech, Inc. · Dec 1991
OPUS FSH
K911409 · Pb Diagnostic Systems, Inc. · Apr 1991