Cleared Traditional

K083386 - ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) (FDA 510(k) Clearance)

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

K083386 · Siemens Healthcare Diagnostics · Chemistry device
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Apr 2009
Decision
136d
Days
Class 2
Risk

K083386 is an FDA 510(k) clearance for the ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/.... Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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.

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Submission Details

510(k) Number K083386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date April 02, 2009
Days to Decision 136 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
48d slower than avg
Panel avg: 88d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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.