Product code PCA

Device name

Dna Genetic Analyzer

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.2570

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset