Cleared Traditional

K191030 - Applied Biosystems 3500 Dx Genetic Anal...

K191030 is an FDA 510(k) clearance for Applied Biosystems 3500 Dx Genetic Anal..., manufactured by Life Technologies Corporation. The device is a Class 2 Toxicology device with product code PCA cleared through the Traditional 510(k) pathway after a 309-day FDA review.

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

FDA 510(k) Submission Details - K191030

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
Combination Product No
PCCP Authorized No
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.

PCA Device Classification - Class 2, Special Controls

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.