QIAstat-Dx Respiratory Panel Mini

Q: What is the product code of K242353?

The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.

FDA 510(k) K242353 · QIAGEN GmbH

Substantially Equivalent

510(k) numberK242353

Submission

Device name: QIAstat-Dx Respiratory Panel Mini
Applicant: QIAGEN GmbH
Hilden, DE
Received: August 8, 2024
Decision date: October 25, 2024
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3981
Specialty: Microbiology

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…

Other 510(k)s with product code QOF

510(k)	Device	Applicant	Decision
K261837	FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional	Baebies, Inc.	09/11/2026SE
K252932	Fast PCR Mini Respiratory PanelQOF · Dual Track	Autonomous Medical Devices Incorporated	06/12/2026SE
K252269	FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track	Baebies, Inc.	03/30/2026SE
K251742	VELO Respiratory TestQOF · Dual Track	Lex Diagnostics Limited	02/13/2026SE
K251978	Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track	Diasorin Molecular, LLC	12/23/2025SE
K252387	Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional	Diasorin Molecular, LLC	10/30/2025SE
K250080	QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional	QIAGEN GmbH	08/27/2025SE
K243544	BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track	Biofire Diagnostics, LLC	08/14/2025SE
K243455	cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional	Roche Molecular Systems, Inc.	07/31/2025SE
K250996	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	Cepheid®	05/01/2025SE

More from Cepheid®

510(k)	Device	Decision
K254194	QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional	08/06/2026SE
K254032	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	03/09/2026SE
K252329	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	10/22/2025SE
K250080	QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional	08/27/2025SE
K250324	QIAstat-Dx GI Panel 2 Mini BPCH · Special	02/28/2025SE
K243813	QIAstat-Dx GI Panel 2 Mini B&VPCH · Special	01/08/2025SE
K242256	QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO · Traditional	10/29/2024SE
K220062	QIAstat-Dx Gastrointestinal Panel 2PCH · Traditional	05/31/2024SE
K233100	QIAstat-Dx® Respiratory Panel PlusQOF · Traditional	05/10/2024SE
K183597	QIAstat-Dx Respiratory PanelOCC · Traditional	05/18/2019SE

Questions and answers

When was QIAstat-Dx Respiratory Panel Mini cleared by the FDA?

QIAstat-Dx Respiratory Panel Mini (K242353) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 78 days after the submission was received.

What is the product code of K242353?

The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.