K191030 is an FDA 510(k) clearance for the Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer. This device is classified as a Dna Genetic Analyzer (Class II - Special Controls, product code PCA).
Submitted by Life Technologies Corporation (Carlsbad, 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 FDA review panel. Regulated under 21 CFR 862.2570. 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..
| 510(k) Number | K191030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |