Devices · InDevR, Inc.

FluChip-8G Influenza A+B Assay

InDevR, Inc. is listed for FluChip-8G Influenza A+B Assay (K182513). The FDA list gives April 22, 2019 as the date of the final decision. The lead panel is Microbiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OZE as “Influenza A And Influenza B Multiplex Nucleic Acid Assay”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K182513

Official FDA database record

Date of final decision

April 22, 2019

Company on the FDA list

InDevR, Inc.

Lead panel

Microbiology

Primary product code

OZE

openFDA device name for the code

Influenza A And Influenza B Multiplex Nucleic Acid Assay

Device class

2

Regulation number

866.3980

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary