Dna Genetic Analyzer
Device Code: 652
Product Code(s):
PCA 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 Sequen
Device Classification Information
| Device Type ID | 652 |
| Device Name | Dna Genetic Analyzer |
| Physical State | Should Not Include Massively Parallel Or High-throughput Sequencers Or Instruments With Analyzers For Fluorescence. |
| Technical Method | Utilizes Denatured Capillary Electrophoresis By Separating Fluorescently Labeled Amplified DNA Fragments Or Individual Nucleotide Bases By Size And Charge Using A Polymer-based Separation Matrix. It May Integrate Sample And/or Reagent Handling, Dedic |
| Target Area | N/A |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 652 |
| Device | Dna Genetic Analyzer |
| Product Code | PCA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
| Device Problems |
|---|
Device Operates Differently Than Expected | 1 |
Failure To Calibrate | 1 |
| Total Device Problems | 2 |
TPLC Last Update: 2019-04-02 19:38:08