Cleared Special

K162538 - ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (FDA 510(k) Clearance)

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

K162538 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
66d
Days
Class 2
Risk

K162538 is an FDA 510(k) clearance for the ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) .... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (East Walpole, US). The FDA issued a Cleared decision on November 17, 2016 after a review of 66 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K162538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date November 17, 2016
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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.