Cleared Traditional

Simplexa COVID-19 & Flu A/B Direct

K220963 · Diasorin Molecular, LLC · Microbiology

Mar 2023

Decision

350d

Days

Class 2

Risk

About This 510(k) Submission

K220963 is an FDA 510(k) clearance for the Simplexa COVID-19 & Flu A/B Direct, a Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (Class II — Special Controls, product code QOF), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on March 17, 2023, 350 days after receiving the submission on April 1, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K220963 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2022
Decision Date	March 17, 2023
Days to Decision	350 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QOF — Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3981
Definition	A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.