Cleared Traditional

K990263 - IMMUNOCARD STAT! E. COLI O157:H7

K990263 is an FDA 510(k) clearance for IMMUNOCARD STAT! E. COLI O157:H7, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GMZ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K990263 · Meridian Diagnostics, Inc. · Microbiology device
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Aug 1999
Decision
194d
Days
Class 1
Risk

K990263 is an FDA 510(k) clearance for the IMMUNOCARD STAT! E. COLI O157:H7. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 9, 1999 after a review of 194 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K990263

510(k) Number K990263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1999
Decision Date August 09, 1999
Days to Decision 194 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 102d · This submission: 194d
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 K990263.
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 PLUS
K023599 · Meridian Bioscience, Inc. · Jan 2003
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
WELLCOLEX E.COLI O157:H7
K971663 · Murex Biotech , Ltd. · Dec 1997