Cleared Traditional

K092349 - CLEARVIEW EXACT II INFLUENZA A & B TEST

K092349 is the FDA 510(k) clearance for CLEARVIEW EXACT II INFLUENZA A & B TEST by Inverness Medical, Inc.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K092349 · Inverness Medical, Inc. · Microbiology device
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May 2010
Decision
279d
Days
Class 2
Risk

K092349 is an FDA 510(k) clearance for the CLEARVIEW EXACT II INFLUENZA A & B TEST. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Inverness Medical, Inc. (Scarborough, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 279 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - 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 Inverness Medical, Inc. devices

Submission Details

510(k) Number K092349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date May 10, 2010
Days to Decision 279 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
177d slower than avg
Panel avg: 102d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K092349.
BIOSIGN FLU A+B
K083746 · Princeton BioMeditech Corp. · Nov 2010
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