Cleared Traditional

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 (K083462) - FDA 510(k) Clearance

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

K083462 · Siemens Healthcare Diagnostics · Chemistry device
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Feb 2009
Decision
95d
Days
Class 2
Risk

K083462 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K083462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date February 27, 2009
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 115
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K081319 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
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K080166 · Beckman Coulter, Inc. · Mar 2008