Cleared Traditional

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

K243931 · Centers For Disease Control and Prevention · Microbiology

Mar 2025

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K243931 is an FDA 510(k) clearance for the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4), a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on March 14, 2025, 84 days after receiving the submission on December 20, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K243931 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	March 14, 2025
Days to Decision	84 days
Submission Type	Traditional
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.