Cleared Traditional

VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (K950838) - FDA 510(k) Clearance

Class I Microbiology device.

K950838 · Zymetx, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
479d
Days
Class 1
Risk

K950838 is an FDA 510(k) clearance for the VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES. Classified as Antigens, Ha (including Ha Control), Influenza Virus A, B, C (product code GNT), Class I - General Controls.

Submitted by Zymetx, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on June 17, 1996 after a review of 479 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

View all Zymetx, Inc. devices

Submission Details

510(k) Number K950838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1995
Decision Date June 17, 1996
Days to Decision 479 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
377d slower than avg
Panel avg: 102d · This submission: 479d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNT Antigens, Ha (including Ha Control), 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.