OZE · Class II · 21 CFR 866.3980

FDA Product Code OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay

Under FDA product code OZE, influenza A and B multiplex nucleic acid assay systems are cleared for the rapid molecular diagnosis of influenza.

These assays simultaneously detect and differentiate influenza A and influenza B from respiratory specimens using nucleic acid amplification technology, providing results within hours compared to days for viral culture and distinguishing influenza from other respiratory illnesses.

OZE devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Centers For Disease Control and Prevention, Centers For Disease Control and Prevention (Cdc) and Quidel Corp..

21
Total
21
Cleared
72d
Avg days
2012
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 127d recently vs 63d historically

FDA 510(k) Cleared Influenza A And Influenza B Multiplex Nucleic Acid Assay Devices (Product Code OZE)

21 devices
1–21 of 21
Cleared Sep 30, 2026
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
K263035
Centers For Disease Control and Prevention
Microbiology · 30d
Cleared Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)
K243274
Centers For Disease Control and Prevention
Microbiology · 268d
Cleared Mar 14, 2025
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)
K243931
Centers For Disease Control and Prevention
Microbiology · 84d
Cleared May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
K241110
Centers For Disease Control and Prevention
Microbiology · 29d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236
Quidel Corporation
Microbiology · 32d
Cleared Jun 24, 2022
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
K220801
Abbott Diagnostics Scarborough, Inc.
Microbiology · 98d
Cleared Mar 10, 2020
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
K200370
Centers For Disease Control and Prevention
Microbiology · 25d
Cleared Apr 22, 2019
FluChip-8G Influenza A+B Assay
K182513
Indevr, Inc.
Microbiology · 222d
Cleared Mar 27, 2019
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
K190302
Centers For Disease Control and Prevention
Microbiology · 43d
Cleared Mar 18, 2019
ID NOW Influenza A & B 2
K190204
Alere Scarborough, Inc.
Microbiology · 42d
Cleared Jul 30, 2018
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
K181736
Centers For Disease Control and Prevention (Cdc)
Microbiology · 28d
Cleared Feb 06, 2018
Accula Flu A/Flu B Test
K171641
Mesa Biotech, Inc.
Microbiology · 249d
Cleared Aug 09, 2017
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
K172091
Centers For Disease Control and Prevention
Microbiology · 29d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
K161556
Centers For Disease Control and Prevention (Cdc)
Microbiology · 24d
Cleared Dec 01, 2015
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
K153148
Centers For Disease Control and Prevention (Cdc)
Microbiology · 32d
Cleared Aug 01, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
K141859
Centers For Disease Control and Prevention
Microbiology · 22d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K140857
Centers For Disease Control and Prevention
Microbiology · 22d
Cleared Jan 17, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
K133869
Center For Disease Control and Prevention (Cdc)
Microbiology · 28d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508
Centers For Disease Control and Prevention
Microbiology · 42d
Cleared Aug 29, 2013
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728
Quidel Corp.
Microbiology · 78d
Cleared Mar 15, 2012
QUIDEL MOLECULAR INFLUENZA A+B
K113777
Quidel Corp.
Microbiology · 85d

About Product Code OZE - Regulatory Context

510(k) Submission Activity

21 total 510(k) submissions under product code OZE since 2012, with 21 receiving FDA clearance (average review time: 72 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OZE Product Code

Recent submissions under OZE have taken an average of 127 days to reach a decision - up from 63 days historically. Manufacturers should account for longer review timelines in current project planning.

OZE devices are reviewed by the Microbiology panel. Browse all Microbiology devices →