PCA · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.2570
Classification
FDA Product Code
PCA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.2570
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.