Dna Genetic Analyzer
The DNA Genetic Analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by genetic assays, enabling genetic analysis across multiple loci or markers simultaneously. It falls under the Clinical Chemistry medical specialty and is classified as a Class 2 device under regulation 862.2570, requiring 510(k) premarket notification. These systems are used in molecular diagnostics laboratories for applications such as STR analysis, genotyping, and mutation detection. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PCA
- Device Class
- FDA class 2
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | Feb 21, 2020 | Substantially Equivalent | Life Technologies Corporation |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.