Cleared Special

K132129 - PRODESSE PROFLU+ ASSAY

K132129 is the FDA 510(k) clearance for PRODESSE PROFLU+ ASSAY by Gen-Probe Prodesse, Inc.. It is a Class 2 Microbiology device (product code OCC) cleared through the Special 510(k) pathway after a 30-day FDA review.

K132129 · Gen-Probe Prodesse, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
30d
Days
Class 2
Risk

K132129 is an FDA 510(k) clearance for the PRODESSE PROFLU+ ASSAY. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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 Gen-Probe Prodesse, Inc. devices

Submission Details

510(k) Number K132129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2013
Decision Date August 09, 2013
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
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 - OCC Respiratory Virus Panel Nucleic Acid Assay System

All 32
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K132129.
XPERT FLU/RSV XC ASSAY
K142045 · Cepheid · Nov 2014
LYRA ADENOVIRUS ASSAY
K141931 · Quidel Corporation · Oct 2014
QUIDEL MOLECULAR RSV + HMPV ASSAY
K131813 · Quidel Corp. · Sep 2013
ABBOTT PLEX-ID FLU ASSAY
K121003 · Abbott Laboratories · Dec 2012
XPERT FLU
K123191 · Cepheid · Dec 2012
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · Quidel Corp. · Dec 2011