Cleared Traditional

WELLCOLEX E.COLI O157:H7 (K971663) - FDA 510(k) Clearance

Class I Microbiology device.

K971663 · Murex Biotech , Ltd. · Microbiology device
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Dec 1997
Decision
238d
Days
Class 1
Risk

K971663 is an FDA 510(k) clearance for the WELLCOLEX E.COLI O157:H7. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Murex Biotech , Ltd. (Dartford,Kent, GB). The FDA issued a Cleared decision on December 30, 1997 after a review of 238 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 Biotech , Ltd. devices

Submission Details

510(k) Number K971663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date December 30, 1997
Days to Decision 238 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
136d slower than avg
Panel avg: 102d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GMZ Antigens, 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.