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510(k) K131584

IMDX FLU A/B AND RSV FOR ABBOTT M2000 by Intelligent Medical Devices, Inc. — Product Code OCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2013
Date Received
May 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

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.

Other clearances by Intelligent Medical Devices, Inc.

  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K132235 — IMDX C.DIFFICILE FOR ABBOTT M2000 (October 11, 2013)
  • K123753 — IMDX VANR FOR ABBOTT M2000 (July 17, 2013)

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