Cleared Traditional

WELLCOLEX E-COLI OI57 ZC60 (K962028) - FDA 510(k) Clearance

Class I Microbiology device.

K962028 · Murex Diagnostics, Inc. · Microbiology device
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Nov 1996
Decision
162d
Days
Class 1
Risk

K962028 is an FDA 510(k) clearance for the WELLCOLEX E-COLI OI57 ZC60. Classified as Antisera, All Types, Escherichia Coli (product code GNA), Class I - General Controls.

Submitted by Murex Diagnostics, Inc. (Norcross, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 162 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Murex Diagnostics, Inc. devices

Submission Details

510(k) Number K962028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date November 01, 1996
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNA Antisera, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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.