Accula Flu A/Flu B Test

Q: What is the product code of K171641?

The FDA product code is OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.

FDA 510(k) K171641 · Mesa Biotech, Inc.

Substantially Equivalent

510(k) numberK171641

Submission

Device name: Accula Flu A/Flu B Test
Applicant: Mesa Biotech, Inc.
San Diego, CA, US
Received: June 2, 2017
Decision date: February 6, 2018
Decision: Substantially Equivalent (SESE)
Type: Dual Track 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3980
Specialty: Microbiology

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…

Other 510(k)s with product code OZE

510(k)	Device	Applicant	Decision
K243274	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional	Centers for Disease Control and Prevention	07/11/2025SE
K243931	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional	Centers for Disease Control and Prevention	03/14/2025SE
K241110	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special	Centers for Disease Control and Prevention	05/21/2024SE
K230236	Lyra Influenza A+B AssayOZE · Special	Quidel Corporation	03/03/2023SE
K220801	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE · Special	Abbott Diagnostics Scarborough, Inc.	06/24/2022SE
K200370	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special	Centers for Disease Control and Prevention	03/10/2020SE
K182513	FluChip-8G Influenza A+B AssayOZE · Traditional	Indevr, Inc.	04/22/2019SE
K190302	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Traditional	Centers for Disease Control and Prevention	03/27/2019SE
K190204	ID NOW Influenza A & B 2OZE · Special	Alere Scarborough, Inc.	03/18/2019SE
K181736	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…OZE · Special	Centers For Disease Control and Prevention (CDC)	07/30/2018SE

More from Centers For Disease Control and Prevention (CDC)

510(k)	Device	Decision
K201269	Accula Strep A TestPGX · Dual Track	11/09/2020SE
K181443	Accula RSV TestOCC · Dual Track	11/23/2018SE

Questions and answers

When was Accula Flu A/Flu B Test cleared by the FDA?

Accula Flu A/Flu B Test (K171641) received a 510(k) decision of Substantially Equivalent on February 6, 2018, 249 days after the submission was received.

What is the product code of K171641?

The FDA product code is OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.