Cleared Traditional

K971663 - WELLCOLEX E.COLI O157:H7

K971663 is an FDA 510(k) clearance for WELLCOLEX E.COLI O157:H7, manufactured by Murex Biotech , Ltd.. The device is a Class 1 Microbiology device with product code GMZ cleared through the Traditional 510(k) pathway after a 238-day FDA review.

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

FDA 510(k) Submission Details - K971663

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 102d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

GMZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - GMZ Antigens, All Types, Escherichia Coli

All 8
Devices cleared under the same product code (GMZ) and FDA review panel - the closest regulatory comparables to K971663.
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · Meridian Diagnostics, Inc. · Aug 1999
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · Alexon - Trend, Inc. · Apr 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · Shared Systems, Inc. · Jan 1998
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · Guardian Scientific, Corp. · Oct 1997
PF TEST
K884513 · Medi-Tech, Inc. · Feb 1989