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510(k) K200065

cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System by Roche Molecular Systems, Inc. — Product Code OCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2020
Date Received
January 13, 2020
Clearance Type
Special
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.

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  • K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (July 6, 2022)
  • K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (February 16, 2021)
  • K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pa (August 22, 2020)
  • K192485 — BioCode Respiratory Pathogen Panel (RPP) (December 23, 2019)
  • K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT (December 11, 2019)
  • K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (July 24, 2019)
  • K191534 — ID NOW Influenza A & B 2 (July 11, 2019)