Cleared Traditional

K091235 - RAMP RSV ASSAY

K091235 is the FDA 510(k) clearance for RAMP RSV ASSAY by Response Biomedical Corp.. It is a Class 1 Microbiology device (product code GQG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K091235 · Response Biomedical Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
88d
Days
Class 1
Risk

K091235 is an FDA 510(k) clearance for the RAMP RSV ASSAY. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Response Biomedical Corp. (Vancouver, B.C, CA). The FDA issued a Cleared decision on July 24, 2009 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Response Biomedical Corp. devices

Submission Details

510(k) Number K091235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date July 24, 2009
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
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 K091235.
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
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QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · Quidel Corp. · Apr 2007
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · Meridian Bioscience, Inc. · Aug 2004
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003