Cleared Special

K092633 - OSOM INFLUENZA A&B TEST

K092633 is the FDA 510(k) clearance for OSOM INFLUENZA A&B TEST by Genzyme Corporation. It is a Class 2 Microbiology device (product code PSZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K092633 · Genzyme Corporation · Microbiology device
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Sep 2009
Decision
29d
Days
Class 2
Risk

K092633 is an FDA 510(k) clearance for the OSOM INFLUENZA A&B TEST , MODEL PN190. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 29 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.

View all Genzyme Corporation devices

Submission Details

510(k) Number K092633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2009
Decision Date September 25, 2009
Days to Decision 29 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
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K092633.
BD DIRECTIGEN EX FLU A+B
K101461 · Becton, Dickinson and Company · Jun 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · Becton, Dickinson & CO · Jun 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · Sa Scientific, Inc. · Feb 2010
QUICKVUE INFLUENZA A+B TEST
K092698 · Quidel Corp. · Sep 2009
TRU FLU, MODEL 751230
K092553 · Meridian Bioscience, Inc. · Sep 2009
XPECT FLU A & B
K092423 · Thermo Fisher Scientific · Aug 2009