Cleared Special

Lyra Influenza A+B Assay

K230236 · Quidel Corporation · Microbiology

Mar 2023

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K230236 is an FDA 510(k) clearance for the Lyra Influenza A+B Assay, a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 3, 2023, 32 days after receiving the submission on January 30, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K230236 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2023
Decision Date	March 03, 2023
Days to Decision	32 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Influenza A And B Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Influenza Viral Infections If Used In Conjunction With Other Clinical And Laboratory Findings.