Cleared Abbreviated

K083579 - DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 (FDA 510(k) Clearance)

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

K083579 · Siemens Healthcare Diagnostics · Chemistry device
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Feb 2009
Decision
78d
Days
Class 2
Risk

K083579 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number K083579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2008
Decision Date February 20, 2009
Days to Decision 78 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.