Cleared Special

K101456 - ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMA...

K101456 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMA... by Roche Diagnostics. It is a Class 2 Chemistry device (product code JIX) cleared through the Special 510(k) pathway after a 105-day FDA review.

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.

View all Roche Diagnostics devices

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
Combination Product No
PCCP Authorized No
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 182
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K101456.
ELECSYS ANTI-TPO CALSET
K103171 · Roche Diagnostics · Feb 2011
MULTICONSTITUENT CALIBRATOR
K103403 · Abbott Laboratories · Feb 2011
DIMENSION VISA ENZ 2 CAL
K103612 · Siemens Healthcare Diagnostics, Inc. · Jan 2011
LOCI 8 CALIBRATOR, MODEL KC 646
K101460 · Siemens Healthcare Diagnostics · Jul 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
K100778 · Siemens Healthcare Diagnostics · May 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · Siemens Healthcare Diagnostics · Mar 2010