Cleared Traditional

K072658 - ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

K072658 is an FDA 510(k) clearance for ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, manufactured by Siemens Medical Solutions Diagnostics. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K072658 · Siemens Medical Solutions Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
194d
Days
Class 2
Risk

K072658 is an FDA 510(k) clearance for the ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Siemens Medical Solutions Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on April 1, 2008 after a review of 194 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions Diagnostics devices

FDA 510(k) Submission Details - K072658

510(k) Number K072658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2007
Decision Date April 01, 2008
Days to Decision 194 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 105d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 50
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K072658.
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · Abaxis, Inc. · Jan 2010
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp. · Mar 2008
I-CHROMA CRP TEST
K062981 · Boditech Diagnostics, Inc. · Jul 2007
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc. · Sep 2006