FDA product code · Clinical chemistry

Dna Genetic Analyzer

Name: FDA decisions, review times, recalls and adverse event reports for product code PCA
Creator: 510(k) Report

PCAClass II21 CFR 862.2570510(k) exempt1 decision since 20200 recalls

FDA lists PCA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2020. No recall names this code.

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.…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of PCA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PCA

1in 2020

2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PCA

Too few PCA 510(k)s in any year since 2007 to give a median.

Recalls per year · PCA

No recall names PCA since 2007.

Adverse event reports per year · PCA

2in 2025

2007high 2 (2014) · low 0 (2007)2025

MAUDE reports naming product code PCA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	2
2015	0	—	1
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	1
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	2
2026	0	—	—

FIG. 1 — PCA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PCA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.2570.

OUE Micro Total Analysis Instrument System PHG Droplet Digital Pcr System OVA Complete Gene Expression Profiling Accessory…OOI Real Time Nucleic Acid Amplification System PQQ Data Acquisition Software NSU Instrumentation For Clinical Multiplex Test…OTA Mass Spectrometer For Clinical Multiplex Test…

Dna Genetic Analyzer

Which PCA devices have the deepest lineage?

What has FDA decided in PCA lately?

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