Cleared Traditional

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES (K984596) - FDA 510(k) Clearance

Class I Microbiology device.

K984596 · Zymetx, Inc. · Microbiology device
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Mar 1999
Decision
66d
Days
Class 1
Risk

K984596 is an FDA 510(k) clearance for the VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES. Classified as Antisera, Neutralization, Influenza Virus A, B, C (product code GNR), Class I - General Controls.

Submitted by Zymetx, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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 Zymetx, Inc. devices

Submission Details

510(k) Number K984596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1998
Decision Date March 04, 1999
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNR Antisera, Neutralization, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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.