510(k) K191030
K191030 is an FDA 510(k) premarket notification submitted by Life Technologies Corporation for the device "Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code PCA (Dna Genetic Analyzer), a Class II device regulated under 21 CFR 862.2570. Life Technologies Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- April 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna Genetic Analyzer
- Device Class
- Class II
- Regulation Number
- 862.2570
- Review Panel
- CH
- Submission Type
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.