Cleared Traditional

K964870 - RSV ANTIGEN CONTROL SLIDES

K964870 is an FDA 510(k) clearance for RSV ANTIGEN CONTROL SLIDES, manufactured by Viral Antigens, Inc.. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K964870 · Viral Antigens, Inc. · Microbiology device
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Mar 1997
Decision
103d
Days
Class 1
Risk

K964870 is an FDA 510(k) clearance for the RSV ANTIGEN CONTROL SLIDES. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Viral Antigens, Inc. (Memphis, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - 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 Viral Antigens, Inc. devices

FDA 510(k) Submission Details - K964870

510(k) Number K964870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1996
Decision Date March 18, 1997
Days to Decision 103 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 102d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

GQG Device Classification - Class 1, General Controls

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
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 - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 27
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K964870.
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K896097 · Vitek Systems, Inc. · Feb 1990
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