Cleared Traditional

EXL ANEM CAL, MODEL RC640 (K093645) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 126
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K093645.
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K101456 · Roche Diagnostics · Sep 2010
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · Siemens Healthcare Diagnostics, Inc. · May 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · Roche Diagnostics Corp. · May 2008
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc. · Oct 2007