Cleared Traditional

K120911 - XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

K120911 is an FDA 510(k) clearance for XPERT FLU GENEXPERT DX SYSTEMS (GX-I, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code OQW cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K120911 · Cepheid · Microbiology device
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May 2012
Decision
53d
Days
Class 2
Risk

K120911 is an FDA 510(k) clearance for the XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV). Classified as 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (product code OQW), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on May 18, 2012 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3332 - 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 Cepheid devices

FDA 510(k) Submission Details - K120911

510(k) Number K120911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date May 18, 2012
Days to Decision 53 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 102d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OQW Device Classification - Class 2, Special Controls

Product Code OQW 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3332
Definition 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens
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 - OQW 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification

All 7
Devices cleared under the same product code (OQW) and FDA review panel - the closest regulatory comparables to K120911.
PRODESSE PROFAST+ ASSAY
K132237 · Gen-Probe Prodesse, Inc. · Aug 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K130551 · Centers For Disease Control and Prevention · May 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905 · Centers For Disease Control and Prevention · Jan 2013
JBAIDS INFLUENZA A SUBTYPING KIT
K111778 · U.S Army Medical Materiel Development Activity · Sep 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507 · Centers For Disease Control and Prevention · Aug 2011
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
K103766 · Cepheid · Apr 2011