Cleared Abbreviated

K103548 - ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 (FDA 510(k) Clearance)

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

K103548 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Jun 2011
Decision
181d
Days
Class 2
Risk

K103548 is an FDA 510(k) clearance for the ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (East Walpole, US). The FDA issued a Cleared decision on June 2, 2011 after a review of 181 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device 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, Inc. devices

Submission Details

510(k) Number K103548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date June 02, 2011
Days to Decision 181 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 104d · This submission: 181d
Pathway characteristics
Standards-based clearance path.

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 Immunology devices follow this clearance model.