Cleared Abbreviated

K083579 - DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

K083579 is an FDA 510(k) clearance for DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code JIX cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K083579 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K083579

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

JIX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 282
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K083579.
STA - FREE PS CALIBRATOR
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CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
K090283 · Genchem, Inc. · Jun 2009
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404 · Medica Corp. · Mar 2009
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · SENTINEL CH. SpA · Jun 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
K073612 · Thermofisher Scientific OY · May 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · Siemens Healthcare Diagnostics, Inc. · May 2008