Product Code: NSU FDA class 2 21 CFR 862.2570

Instrumentation For Clinical Multiplex Test Systems

Clinical Chemistry

The Instrumentation for Clinical Multiplex Test Systems is a device designed to measure and sort multiple signals generated by clinical assays from a single sample, using fluorescence, luminescence, or other physical and chemical properties. The system may integrate scanning, reagent handling, hybridization, washing, instrument control, and data acquisition components, and is used together with specific assays to measure multiple analytes of a similar chemical nature. It is an FDA Class 2 device regulated under 21 CFR 862.2570 in the Clinical Chemistry specialty, with product code NSU, and is exempt from premarket notification under submission type 4. It is not an implant and does not carry life-sustaining support designation.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: NSU
Device Class: FDA class 2
Regulation Number: 862.2570
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

Definition

Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K163652	ePlex Instrument	Jun 09, 2017	Substantially Equivalent	Genmark Diagnostics, Incorporated
K143178	FilmArray 2.0 System	Jan 30, 2015	Substantially Equivalent	Biofire Diagnostics, LLC
K133849	VANTERA CLINICAL ANALYZER	Oct 22, 2014	Substantially Equivalent	Liposcience
K141220	APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE	May 22, 2014	Substantially Equivalent	Thermo Fisher Scientific (Life Technologies Holdin
K133302	FLEXMAP 3D	Jan 10, 2014	Substantially Equivalent	Luminex Corp.
K121399	LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P	Jan 09, 2013	Substantially Equivalent	Luminex Corp.
K110786	ESENSOR WARFARIN SENSITIVITY SALIVA TEST	Dec 02, 2011	Substantially Equivalent	GenMark Diagnostics, Inc.
K093128	ILLUMINA BEADXPRESS SYSTEM	Apr 28, 2010	Substantially Equivalent	Illumina, Inc.
K082562	APPLIED BIOSYSTEMS 7500 FAST DX	Sep 30, 2008	Substantially Equivalent	Applied Biosystems, Inc.
K080995	MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	Jul 30, 2008	Substantially Equivalent	Affymetrix, Inc.
K073506	LUMINEX LX 100/200 INSTRUMENT	Mar 07, 2008	Substantially Equivalent	Luminex Corp.
K070597	VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST	Oct 11, 2007	Substantially Equivalent	Nanosphere, Inc.
DEN040012	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	Dec 23, 2004	Unknown	Affymetrix, Inc.