Cleared Special

K093116 - MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

K093116 is an FDA 510(k) clearance for MODIFICATION TO: RAMP INFLUENZA A/B ASSAY, manufactured by Response Biomedical Corp.. The device is a Class 2 Microbiology device with product code PSZ cleared through the Special 510(k) pathway after a 19-day FDA review.

K093116 · Response Biomedical Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
19d
Days
Class 2
Risk

K093116 is an FDA 510(k) clearance for the MODIFICATION TO: RAMP INFLUENZA A/B ASSAY. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Response Biomedical Corp. (Vancouver, B.C, CA). The FDA issued a Cleared decision on October 21, 2009 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093116

510(k) Number K093116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date October 21, 2009
Days to Decision 19 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

PSZ Device Classification - Class 2, Special Controls

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3328
Definition An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 72
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K093116.
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · Becton, Dickinson & CO · Jun 2010
CLEARVIEW EXACT II INFLUENZA A & B TEST
K092349 · Inverness Medical, Inc. · May 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · Sa Scientific, Inc. · Feb 2010
OSOM INFLUENZA A&B TEST , MODEL PN190
K092633 · Genzyme Corporation · Sep 2009
QUICKVUE INFLUENZA A+B TEST
K092698 · Quidel Corp. · Sep 2009
TRU FLU, MODEL 751230
K092553 · Meridian Bioscience, Inc. · Sep 2009
K093116 · MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
Download PDF FDA Summary Response Biomedical C…