FDA product code PCA: Dna Genetic Analyzer
PCA is the FDA product code for dna genetic analyzer. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under PCA. The average 510(k) review took 309 days (median 309).
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.
Classification
| Field | Value |
|---|---|
| Device name | Dna Genetic Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PCA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 309 |
Compare with all 510(k) review times · Search every PCA clearance
Top PCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life Technologies Corporation | 1 | 2020-02-21 |
Most recent PCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191030 | Life Technologies Corporation | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | 2020-02-21 | 309 |
Recalls for PCA devices
openFDA lists no recalls for product code PCA.
Frequently asked questions
What is FDA product code PCA?
PCA is the FDA product code for dna genetic analyzer. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is PCA?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PCA?
Across 1 cleared submissions the average was 309 days from receipt to decision (median 309).
Which companies have the most PCA clearances?
Life Technologies Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCA
- Run a recall and safety report across every PCA manufacturer
- Watch product code PCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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