Cleared Special

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM (K101456) - FDA 510(k) Clearance

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

K101456 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
105d
Days
Class 2
Risk

K101456 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRA.... Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 8, 2010 after a review of 105 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. 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. Standard predicate reliance. 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 K101456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2010
Decision Date September 08, 2010
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 301
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