Cleared Traditional

K962028 - WELLCOLEX E-COLI OI57 ZC60

K962028 is an FDA 510(k) clearance for WELLCOLEX E-COLI OI57 ZC60, manufactured by Murex Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GNA cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K962028

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

GNA Device Classification - Class 1, General Controls

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.

Regulatory Peers - GNA Antisera, All Types, Escherichia Coli

All 10
Devices cleared under the same product code (GNA) and FDA review panel - the closest regulatory comparables to K962028.
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PREMIER EHEC
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RIM E.COLI 0157:H7 LATEX TEST
K933457 · Remel Co. · Apr 1994