Cleared Traditional

Applied Biosystems? 3500 Dx Genetic Analyzer and Applied Biosystems? 3500xL Dx Genetic Analyzer

K191030 · Life Technologies Corporation · Toxicology
Feb 2020
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K191030 is an FDA 510(k) clearance for the Applied Biosystems? 3500 Dx Genetic Analyzer and Applied Biosystems? 3500xL Dx Genetic Analyzer, a Dna Genetic Analyzer (Class II — Special Controls, product code PCA), submitted by Life Technologies Corporation (Carlbad, US). The FDA issued a Cleared decision on February 21, 2020, 309 days after receiving the submission on April 18, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number K191030 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2019
Decision Date February 21, 2020
Days to Decision 309 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code PCA — Dna Genetic Analyzer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.2570
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.