Cleared Traditional

RSV ANTIGEN CONTROL SLIDES (K964870) - FDA 510(k) Clearance

Class I Microbiology device.

K964870 · Viral Antigens, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 102d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K964870.
Clungene RSV Antigen Rapid Test
K253318 · Hangzhou Clongene Biotech Co., Ltd. · Jan 2026
Nano-Check™ RSV Test
K240280 · Nano-Ditech Corporation · Jul 2024
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · Abbott Laboratories · Jun 1988
ABBOTT TESTPACK RSV
K874127 · Abbott Laboratories · May 1988