Cleared Special

K112199 - XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
(FDA 510(k) Clearance)

K112199 · Luminex Molecular Diagnostics, Inc. · Microbiology

Sep 2011

Decision

31d

Days

Class 2

Risk

K112199 is an FDA 510(k) clearance for the XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1), a Respiratory Virus Panel Nucleic Acid Assay System (Class II — Special Controls, product code OCC), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on September 1, 2011, 31 days after receiving the submission on August 1, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K112199 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2011
Decision Date	September 01, 2011
Days to Decision	31 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	OCC — Respiratory Virus Panel Nucleic Acid Assay System
Device Class	Class II — 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.