Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k) K163266 · Alere Scarborough, Inc.

Substantially Equivalent

510(k) numberK163266

Submission

Device name
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
Applicant
Alere Scarborough, Inc.
Scarborough, ME, US
Received
November 21, 2016
Decision date
December 21, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OCC – Respiratory Virus Panel Nucleic Acid Assay System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3980
Specialty
Microbiology

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…

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Questions and answers

When was Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument cleared by the FDA?

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (K163266) received a 510(k) decision of Substantially Equivalent on December 21, 2016, 30 days after the submission was received.

What is the product code of K163266?

The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.