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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 and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible