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U.S. Department of Health and Human Services

Product Classification
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Device dna genetic analyzer
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide sequences and DNA fragment sizes are identified using chain- or dye-termination or dye primer cycle sequencing, or PCR amplification with labeled primers, respectively. Labeled nucleotides and DNA fragments are separated by size and charge using a polymer-based separation matrix with capillary electrophoresis or other method. Fluorescence emissions are measured using filters on a photodiode or other detector and interpreted with software.
Physical State Should not include massively parallel or high-throughput sequencers or instruments with analyzers for fluorescence.
Technical Method Utilizes denatured capillary electrophoresis by separating fluorescently labeled amplified DNA fragments or individual nucleotide bases by size and charge using a polymer-based separation matrix. It may integrate sample and/or reagent handling, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.
Target Area N/A
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePCA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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