Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5270](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5270) → DCN — System, Test, C-Reactive Protein # DCN · System, Test, C-Reactive Protein _Immunology · 21 CFR 866.5270 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN ## Overview - **Product Code:** DCN - **Device Name:** System, Test, C-Reactive Protein - **Regulation:** [21 CFR 866.5270](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5270) - **Device Class:** 2 - **Review Panel:** [Immunology](/submissions/IM) - **3rd-party reviewable:** yes ## Identification A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 70) Showing 20 most recent of 70 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232624](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K232624.md) | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | Nov 27, 2023 | SESE | | [K221119](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K221119.md) | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | Mar 17, 2023 | SESE | | [K192072](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K192072.md) | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | Feb 21, 2020 | SESE | | [K180099](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K180099.md) | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | Oct 12, 2018 | SESE | | [K172868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K172868.md) | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | Feb 28, 2018 | SESE | | [K171498](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K171498.md) | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | Jan 12, 2018 | SESE | | [K161982](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K161982.md) | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | Apr 5, 2017 | SESE | | [K113809](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K113809.md) | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | Hitachi Chemical Diagnostics, Inc. | Aug 17, 2012 | SESE | | [K091052](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K091052.md) | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | Jan 15, 2010 | SESE | | [K083444](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K083444.md) | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | Mar 18, 2009 | SESE | | [K083412](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K083412.md) | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | Mar 9, 2009 | SESE | | [K083040](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K083040.md) | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | Jan 30, 2009 | SESE | | [K072658](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K072658.md) | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | Apr 1, 2008 | SESE | | [K073277](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K073277.md) | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | Mar 6, 2008 | SESE | | [K062981](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K062981.md) | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | Jul 13, 2007 | SESE | | [K061825](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K061825.md) | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH | Dade Behring, Inc. | Sep 6, 2006 | SESE | | [K050713](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K050713.md) | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 | Good Biotech Corp. | Jun 6, 2005 | SESE | | [K040030](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K040030.md) | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Biocheck, Inc. | Jun 16, 2004 | SESE | | [K032336](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K032336.md) | TINA-QUANT CRP (LATEX) | Roche Diagnostics Corp. | Aug 5, 2003 | SESE | | [K030899](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN/K030899.md) | C-REACTIVE PROTEIN (CRP) | Abbott Laboratories | Jul 2, 2003 | SESE | ## Top Applicants - Roche Diagnostics Corp. — 4 clearances - Good Biotech Corp. — 4 clearances - Dade Behring, Inc. — 3 clearances - Wako Chemicals USA, Inc. — 2 clearances - The Binding Site Group , Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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