PCA

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dna Genetic Analyzer

Device class

Class II (moderate risk)

Regulation

21 CFR 862.2570

Medical specialty

Clinical Chemistry

FDA 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.

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