Cleared Traditional

VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT (K933575) - FDA 510(k) Clearance

Class I Microbiology device.

K933575 · Symex Corp. · Microbiology device
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Nov 1994
Decision
493d
Days
Class 1
Risk

K933575 is an FDA 510(k) clearance for the VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT. Classified as Antisera, Neutralization, Parainfluenza Virus 1-4 (product code GQP), Class I - General Controls.

Submitted by Symex Corp. (Tulsa, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 493 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K933575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1993
Decision Date November 28, 1994
Days to Decision 493 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
391d slower than avg
Panel avg: 102d · This submission: 493d
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.