Cleared Special

K092423 - XPECT FLU A & B

K092423 is an FDA 510(k) clearance for XPECT FLU A & B, manufactured by Thermo Fisher Scientific. 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.

K092423 · Thermo Fisher Scientific · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
19d
Days
Class 2
Risk

K092423 is an FDA 510(k) clearance for the XPECT FLU A & B. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Lenexa, US). The FDA issued a Cleared decision on August 26, 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 - K092423

510(k) Number K092423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2009
Decision Date August 26, 2009
Days to Decision 19 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 K092423.
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
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · Binax, Inc. · Aug 2009
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc. · Jul 2009
RAMP INFLUENZA A/B ASSAY
K071591 · Response Biomedical Corp. · Apr 2008
K092423 · XPECT FLU A & B
Download PDF FDA Summary Thermo Fisher Scienti…