Cleared Traditional

K191030 - Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191030 · Life Technologies Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
309d
Days
Class 2
Risk

K191030 is an FDA 510(k) clearance for the Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL D.... Classified as Dna Genetic Analyzer (product code PCA), Class II - Special Controls.

Submitted by Life Technologies Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 21, 2020 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2570 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Technologies Corporation devices

Submission Details

510(k) Number K191030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2019
Decision Date February 21, 2020
Days to Decision 309 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 87d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCA Dna Genetic Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.2570
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.