Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

FDA 510(k) K201505 · Diasorin Molecular, LLC

Substantially Equivalent

510(k) numberK201505

Submission

Device name
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
Applicant
Diasorin Molecular, LLC
Cypress, CA, US
Received
June 5, 2020
Decision date
August 22, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OCC – Respiratory Virus Panel Nucleic Acid Assay System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3980
Specialty
Microbiology

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…

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Questions and answers

When was Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack cleared by the FDA?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505) received a 510(k) decision of Substantially Equivalent on August 22, 2020, 78 days after the submission was received.

What is the product code of K201505?

The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.