Product code PCA— Clinical Chemistry
Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
- Classification name
- Dna Genetic Analyzer
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PCA
FDA has cleared device under product code PCA, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PCA
Recent clearances under product code PCA
Data sourced from openFDA. This site is unofficial and independent of the FDA.