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) → DCK — C-Reactive Protein, Antigen, Antiserum, And Control # DCK · C-Reactive Protein, Antigen, Antiserum, And Control _Immunology · 21 CFR 866.5270 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK ## Overview - **Product Code:** DCK - **Device Name:** C-Reactive Protein, Antigen, Antiserum, And Control - **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 126) Showing 20 most recent of 126 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242170](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K242170.md) | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | Apr 18, 2025 | SESE | | [K201256](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K201256.md) | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | Nov 4, 2022 | SESE | | [K192028](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K192028.md) | Yumizen C1200 CRP | HORIBA ABX SAS | Jun 25, 2020 | SESE | | [K192118](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K192118.md) | CRP Vario | SENTINEL CH. SpA | Nov 8, 2019 | SESE | | [K191993](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K191993.md) | Yumizen C1200 CRP | HORIBA ABX SAS | Oct 3, 2019 | SESE | | [K160712](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K160712.md) | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | Jul 14, 2017 | SESE | | [K142993](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K142993.md) | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | Orion Diagnostica, OY | Mar 10, 2016 | SESE | | [K152433](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K152433.md) | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | Sep 24, 2015 | SESE | | [K141689](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K141689.md) | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit | Qualigen, Inc. | Jan 7, 2015 | SESE | | [K121558](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K121558.md) | DIAZYME HSCRP POC TEST KIT | Diazyme Laboratories | Sep 21, 2012 | SESE | | [K103557](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K103557.md) | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | Diazyme Laboratories | Apr 27, 2011 | SESE | | [K061138](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K061138.md) | ABX PENTRA 400 : CRP | Horiba Abx | Sep 29, 2006 | SESE | | [K060139](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K060139.md) | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | Apr 28, 2006 | SESE | | [K052591](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K052591.md) | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Clinical Data, Inc. | Feb 9, 2006 | SESE | | [K050836](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K050836.md) | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | Aug 8, 2005 | SESE | | [K041155](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K041155.md) | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Stanbio Laboratory | Oct 14, 2004 | SESE | | [K042442](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K042442.md) | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE | Orion Diagnostica, OY | Sep 24, 2004 | SESE | | [K040241](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K040241.md) | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Genzyme Corp. | Jun 25, 2004 | SESE | | [K040579](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K040579.md) | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | Cholestech Corp. | Jun 18, 2004 | SESE | | [K032663](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K032663.md) | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 | Instrumentation Laboratory CO | Dec 19, 2003 | SESE | ## Top Applicants - Kamiya Biomedical Co. — 8 clearances - Syva Co. — 5 clearances - E.I. Dupont DE Nemours & Co., Inc. — 5 clearances - Beckman Instruments, Inc. — 4 clearances - Beckman Coulter, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com