Cleared Traditional

K973457 - CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800

K973457 is an FDA 510(k) clearance for CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, manufactured by Shared Systems, Inc.. The device is a Class 1 Microbiology device with product code GMZ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K973457 · Shared Systems, Inc. · Microbiology device
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Jan 1998
Decision
112d
Days
Class 1
Risk

K973457 is an FDA 510(k) clearance for the CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on January 2, 1998 after a review of 112 days - within the typical 510(k) review window.

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 Shared Systems, Inc. devices

FDA 510(k) Submission Details - K973457

510(k) Number K973457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date January 02, 1998
Days to Decision 112 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
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K973457.
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · Meridian Bioscience, Inc. · Jan 2003
IMMUNOCARD STAT! E. COLI O157:H7
K990263 · Meridian Diagnostics, Inc. · Aug 1999
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · Alexon - Trend, Inc. · Apr 1998
WELLCOLEX E.COLI O157:H7
K971663 · Murex Biotech , Ltd. · Dec 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · Guardian Scientific, Corp. · Oct 1997
PF TEST
K884513 · Medi-Tech, Inc. · Feb 1989