Cleared Traditional

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 (K981226) - FDA 510(k) Clearance

Class I Microbiology device.

K981226 · Dako Diagnostics , Ltd. · Microbiology device
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Sep 1998
Decision
188d
Days
Class 1
Risk

K981226 is an FDA 510(k) clearance for the IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA.... Classified as Antisera, Neutralization, Parainfluenza Virus 1-4 (product code GQP), Class I - General Controls.

Submitted by Dako Diagnostics , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on September 28, 1998 after a review of 188 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3400 - 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.

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Submission Details

510(k) Number K981226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1998
Decision Date September 28, 1998
Days to Decision 188 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
86d slower than avg
Panel avg: 102d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQP Antisera, Neutralization, Parainfluenza Virus 1-4
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3400
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.