PCA — Dna Genetic Analyzer Class II

FDA Device Classification

Classification Details

Product Code
PCA
Device Class
Class II
Regulation Number
862.2570
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191030life technologies corporationApplied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx GFebruary 21, 2020