Cleared Traditional

K971494 - VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

K971494 is an FDA 510(k) clearance for VIRAZYME INFLUENZA ID TEST FOR INFLUENZ..., manufactured by Zymetx, Inc.. The device is a Class 1 Microbiology device with product code GNX cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K971494 · Zymetx, Inc. · Microbiology device
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Sep 1997
Decision
139d
Days
Class 1
Risk

K971494 is an FDA 510(k) clearance for the VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Zymetx, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on September 10, 1997 after a review of 139 days - within the typical 510(k) review window.

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: 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 Zymetx, Inc. devices

FDA 510(k) Submission Details - K971494

510(k) Number K971494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1997
Decision Date September 10, 1997
Days to Decision 139 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 102d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

GNX Device Classification - Class 1, General Controls

Product Code GNX Antigens, Cf (including Cf 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.

Regulatory Peers - GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C

All 10
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