Cleared Traditional

K853695 - RESPIRATORY SYNCYTIAL VIRUS ID REAGENT

K853695 is an FDA 510(k) clearance for RESPIRATORY SYNCYTIAL VIRUS ID REAGENT, manufactured by Viromed Laboratories, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K853695

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 K853695.
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · Kallestad Laboratories, Inc. · Sep 1986
ABBOTT RSV EIA
K862429 · Abbott Laboratories · Sep 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K854081 · Boots-Celltech Diagnostics, Inc. · Jan 1986
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936 · Orion Diagnostica, Inc. · Dec 1980
RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
K770804 · Flow Laboratories, Inc. · May 1977
RESP. SYNCYTIAL-FA LABELLED PRESERUM
K770808 · Flow Laboratories, Inc. · May 1977