Cleared Traditional

K853695 - RESPIRATORY SYNCYTIAL VIRUS ID REAGENT

K853695 is the FDA 510(k) clearance for RESPIRATORY SYNCYTIAL VIRUS ID REAGENT by Viromed Laboratories, Inc.. It is a Class 1 Microbiology device (product code GQG) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K853695 · Viromed Laboratories, Inc. · Microbiology device
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Dec 1985
Decision
91d
Days
Class 1
Risk

K853695 is an FDA 510(k) clearance for the RESPIRATORY SYNCYTIAL VIRUS ID REAGENT. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 91 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 Viromed Laboratories, Inc. devices

Submission Details

510(k) Number K853695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date December 04, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 21
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K853695.
ABBOTT TESTPACK RSV
K874127 · Abbott Laboratories · May 1988
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · Kallestad Laboratories, Inc. · Sep 1986
ABBOTT RSV EIA
K862429 · Abbott Laboratories · Sep 1986
RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
K770804 · Flow Laboratories, Inc. · May 1977
RESP. SYNCYTIAL-FA LABELLED PRESERUM
K770808 · Flow Laboratories, Inc. · May 1977