510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCAClass II

Dna Genetic Analyzer

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

PCA is the FDA product code for Dna Genetic Analyzer, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PCA
Device name
Dna Genetic Analyzer
FDA 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.
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PCA

By decision year
1 clearance under product code PCA with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCA by decision year
YearClearances
20201

Applicants with the most clearances

Product code PCA
Applicants holding the most 510(k) clearances under product code PCA
ApplicantClearances
Life Technologies Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code