Cleared Traditional

K232624 - CardioPhase hsCRP

K232624 is an FDA 510(k) clearance for CardioPhase hsCRP, manufactured by Siemens Healthcare Diagnostic Products GmbH. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K232624 · Siemens Healthcare Diagnostic Products GmbH · Immunology device
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Nov 2023
Decision
90d
Days
Class 2
Risk

K232624 is an FDA 510(k) clearance for the CardioPhase® hsCRP. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on November 27, 2023 after a review of 90 days - within the typical 510(k) review window.

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 Healthcare Diagnostic Products GmbH devices

FDA 510(k) Submission Details - K232624

510(k) Number K232624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2023
Decision Date November 27, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
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 40
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K232624.
RCRP Flex reagent cartridge
K221119 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Tina-quant C-Reactive Protein IV
K192072 · Roche Diagnostics Operations (Rdo) · Feb 2020
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009