Cleared Traditional

K990263 - IMMUNOCARD STAT! E. COLI O157:H7 (FDA 510(k) Clearance)

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 102d · This submission: 194d
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.