Cleared Traditional

K023599 - IMMUNOCARD STAT! E. COLI O157 PLUS

K023599 is an FDA 510(k) clearance for IMMUNOCARD STAT! E. COLI O157 PLUS, manufactured by Meridian Bioscience, Inc.. The device is a Class 1 Microbiology device with product code GMZ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K023599 · Meridian Bioscience, Inc. · Microbiology device
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Jan 2003
Decision
67d
Days
Class 1
Risk

K023599 is an FDA 510(k) clearance for the IMMUNOCARD STAT! E. COLI O157 PLUS. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 3, 2003 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meridian Bioscience, Inc. devices

FDA 510(k) Submission Details - K023599

510(k) Number K023599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date January 03, 2003
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
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 10
Devices cleared under the same product code (GMZ) and FDA review panel - the closest regulatory comparables to K023599.
SHIGA TOXIN QUIK CHEK
K121364 · Techlab Inc., Corporate Research Center · Oct 2012
SHIGA TOXIN CHEK
K121411 · Techlab Inc., Corporate Research Center · Oct 2012
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546 · Meridian Bioscience, Inc. · Feb 2007
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