Product Code: OZE FDA class 2 21 CFR 866.3980

Influenza A And Influenza B Multiplex Nucleic Acid Assay

Microbiology

The 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 from human respiratory specimens, aiding in the diagnosis of respiratory tract influenza infections when used in conjunction with other clinical and laboratory findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZE, with regulation number 866.3980 under the Microbiology medical specialty.

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Basic Information

Product Code: OZE
Device Class: FDA class 2
Regulation Number: 866.3980
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243274	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 Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)	Jul 11, 2025	Substantially Equivalent	Centers for Disease Control and Prevention
K243931	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)	Mar 14, 2025	Substantially Equivalent	Centers for Disease Control and Prevention
K241110	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)	May 21, 2024	Substantially Equivalent	Centers for Disease Control and Prevention
K230236	Lyra Influenza A+B Assay	Mar 03, 2023	Substantially Equivalent	Quidel Corporation
K220801	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2	Jun 24, 2022	Substantially Equivalent	Abbott Diagnostics Scarborough, Inc.
K200370	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit	Mar 10, 2020	Substantially Equivalent	Centers for Disease Control and Prevention
K182513	FluChip-8G Influenza A+B Assay	Apr 22, 2019	Substantially Equivalent	Indevr, Inc.
K190302	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit	Mar 27, 2019	Substantially Equivalent	Centers for Disease Control and Prevention
K190204	ID NOW Influenza A & B 2	Mar 18, 2019	Substantially Equivalent	Alere Scarborough, Inc.
K181736	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,	Jul 30, 2018	Substantially Equivalent	Centers For Disease Control and Prevention (CDC)
K171641	Accula Flu A/Flu B Test	Feb 06, 2018	Substantially Equivalent	Mesa Biotech, Inc.
K172091	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit	Aug 09, 2017	Substantially Equivalent	Centers for Disease Control and Prevention
K161556	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit	Jun 30, 2016	Substantially Equivalent	Centers For Disease Control and Prevention (CDC)
K153148	CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping	Dec 01, 2015	Substantially Equivalent	Centers For Disease Control and Prevention (CDC)
K141859	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING	Aug 01, 2014	Substantially Equivalent	Centers for Disease Control and Prevention
K140857	INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	Apr 25, 2014	Substantially Equivalent	Centers for Disease Control and Prevention
K133869	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT	Jan 17, 2014	Substantially Equivalent	Center For Disease Control and Prevention (Cdc)
K132508	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL	Sep 23, 2013	Substantially Equivalent	Centers for Disease Control and Prevention
K131728	QUIDEL MOLECULAR INFLUENZA A + B ASSAY	Aug 29, 2013	Substantially Equivalent	Quidel Corp.
K113777	QUIDEL MOLECULAR INFLUENZA A+B	Mar 15, 2012	Substantially Equivalent	Quidel Corp.