FilmArray Pneumonia Panel plus

Q: What is the product code of K181324?

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) K181324 · Biofire Diagnostics, LLC

Substantially Equivalent

510(k) numberK181324

Submission

Device name: FilmArray Pneumonia Panel plus
Applicant: Biofire Diagnostics, LLC
Salt Lake City, UT, US
Received: May 18, 2018
Decision date: November 15, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K222601	FilmArray Pneumonia Panel plusQDS · Special	Biofire Diagnostics, LLC	10/27/2022SE

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K222601	FilmArray Pneumonia Panel plusQDS · Special	10/27/2022SE

Questions and answers

When was FilmArray Pneumonia Panel plus cleared by the FDA?

FilmArray Pneumonia Panel plus (K181324) received a 510(k) decision of Substantially Equivalent on November 15, 2018, 181 days after the submission was received.

What is the product code of K181324?

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.