Cleared Special

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

K220801 · Abbott Diagnostics Scarborough, Inc. · Microbiology

Jun 2022

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K220801 is an FDA 510(k) clearance for the ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2, a Influenza A And Influenza B Multiplex Nucleic Acid Assay (Class II — Special Controls, product code OZE), submitted by Abbott Diagnostics Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on June 24, 2022, 98 days after receiving the submission on March 18, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K220801 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2022
Decision Date	June 24, 2022
Days to Decision	98 days
Submission Type	Special
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.