Cleared Traditional

K093645 - EXL ANEM CAL

K093645 is an FDA 510(k) clearance for EXL ANEM CAL, 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 100-day FDA review.

K093645 · Siemens Healthcare Diagnostics · Chemistry device
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Mar 2010
Decision
100d
Days
Class 2
Risk

K093645 is an FDA 510(k) clearance for the EXL ANEM CAL, MODEL RC640. 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 March 5, 2010 after a review of 100 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K093645

510(k) Number K093645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2009
Decision Date March 05, 2010
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 K093645.
LOCI 8 CALIBRATOR, MODEL KC 646
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K080404 · Medica Corp. · Mar 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · Siemens Healthcare Diagnostics · Feb 2009
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · Siemens Healthcare Diagnostics, Inc. · May 2008