510(k) Premarket Notification

• Device Classification Name: respiratory virus panel nucleic acid assay system
• 510(K) Number: K112199
• Model: 1019C0111, 3N30-01, S019-0116, 3N30-10
• Device Name: XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
• Applicant: LUMINEX MOLECULAR DIAGNOSTICS, INC.; 439 university ave.; suite 900; toronto, ontario,
• Contact: lubna syed
• Regulation Number: 866.3980
• Classification Product Code: OCC
• Subsequent Product Codes: NSU OEM OEP
• Date Received: 08/10/2011
• Decision Date: 09/01/2011
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• summary: summary
• FDA Review: Decision Summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No