Cleared Traditional

K930304 - COBAS CORE FSH EIA

K930304 is the FDA 510(k) clearance for COBAS CORE FSH EIA by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 37
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K930304.
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
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
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · Ciba Corning Diagnostics Corp. · Nov 1990