FilmArray Pneumonia Panel plus

Q: What is the product code of K222601?

The FDA product code is QDS – Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.4001.

FDA 510(k) K222601 · Biofire Diagnostics, LLC

Substantially Equivalent

510(k) numberK222601

Submission

Device name: FilmArray Pneumonia Panel plus
Applicant: Biofire Diagnostics, LLC
Salt Lake City, UT, US
Received: August 29, 2022
Decision date: October 27, 2022
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QDS – Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.4001
Specialty: Pathology

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens associated nucleic acids in human clinical specimens. The test is indicated for…

Other 510(k)s with product code QDS

510(k)	Device	Applicant	Decision
K243222	BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY®…QDS · Special	Biofire Diagnostics, LLC (Biomerieux)	11/06/2024SE
K181324	FilmArray Pneumonia Panel plusQDS · Traditional	Biofire Diagnostics, LLC	11/15/2018SE

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Questions and answers

When was FilmArray Pneumonia Panel plus cleared by the FDA?

FilmArray Pneumonia Panel plus (K222601) received a 510(k) decision of Substantially Equivalent on October 27, 2022, 59 days after the submission was received.

What is the product code of K222601?

The FDA product code is QDS – Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.4001.