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U.S. Department of Health and Human Services

Product Classification

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Device micro total analysis instrument system
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.
Physical State Should not include microarray systems or standard immunoelectrophoresis systems.
Technical Method A micro total analysis instrument system is an automated instrument for clinical multiplex test systems which uses electrokinetic mixing and isotachophoresis on a microfluidic chip to create immune complexes between target analyte(s) from a clinical specimen and fluorescently labeled antibodies. The complexes are detected and quantified using laser-induced-fluorescence detection after capillary gel electrophoresis. The chips contain discrete zones for loading and mixing the sample and assay reagents and for electrophoretic separation. It includes an automated chip loading and transport mechanism, reagent handling (fluidic) system, electrophoresis power supply, control and monitoring systems.
Target Area N/A
Regulation Medical Specialty Clinical Chemistry
Review Panel Immunology
Product CodeOUE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(K) Exempt
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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