Cleared Traditional

K100778 - DIMENSION EXL LOCI THYROID CALIBRATOR

K100778 is an FDA 510(k) clearance for DIMENSION EXL LOCI THYROID CALIBRATOR, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K100778 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
47d
Days
Class 2
Risk

K100778 is an FDA 510(k) clearance for the DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on May 5, 2010 after a review of 47 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K100778

510(k) Number K100778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2010
Decision Date May 05, 2010
Days to Decision 47 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

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 245
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K100778.
DIMENSION VISA ENZ 2 CAL
K103612 · Siemens Healthcare Diagnostics, Inc. · Jan 2011
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
K101456 · Roche Diagnostics · Sep 2010
LOCI 8 CALIBRATOR, MODEL KC 646
K101460 · Siemens Healthcare Diagnostics · Jul 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · Siemens Healthcare Diagnostics · Mar 2010
EXL ANEM CAL, MODEL RC640
K093645 · Siemens Healthcare Diagnostics · Mar 2010
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404 · Medica Corp. · Mar 2009