Cleared Special

K133849 - VANTERA CLINICAL ANALYZER (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133849 · Liposcience · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
307d
Days
Class 2
Risk

K133849 is an FDA 510(k) clearance for the VANTERA CLINICAL ANALYZER. Classified as Instrumentation For Clinical Multiplex Test Systems (product code NSU), Class II - Special Controls.

Submitted by Liposcience (Raleigh, US). The FDA issued a Cleared decision on October 22, 2014 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2570 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Liposcience devices

Submission Details

510(k) Number K133849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date October 22, 2014
Days to Decision 307 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 88d · This submission: 307d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NSU Instrumentation For Clinical Multiplex Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.2570
Definition Instrumentation For Clinical Multiplex Test Systems Is A Device That Is Intended To Measure And Sort Multiple Signals Generated By An Assay From A Clinical Sample. The Generated Signals From Multiple Probes Or Other Ligands May Be Measured By Fluorescence, Luminescence, Or Other Physical Or Chemical Properties. The Device May Integrate Scanning, Reagent Handling, Hybridization, Washing, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. This Instrumentation Is Used With Specific Assays To Comprise An Assay Test System To Measure Multiple Analytes Of A Similar Chemical Nature For De
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 Chemistry devices follow this clearance model.