510(k) K142365

Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack by Focus Diagnostics — Product Code OCC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 5, 2014
Date Received: August 25, 2014
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 Focus Diagnostics

K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)
K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

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K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pa (August 22, 2020)
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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)