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) → NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And Control # NQD · Cardiac 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/NQD ## Overview - **Product Code:** NQD - **Device Name:** Cardiac 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 (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260026](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K260026.md) | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | Apr 2, 2026 | SESE | | [K233242](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K233242.md) | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | Jan 18, 2024 | SESE | | [K212559](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K212559.md) | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | Dec 16, 2022 | SESE | | [K173833](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K173833.md) | CRP Vario | SENTINEL CH. SpA | Sep 27, 2018 | SESE | | [K081294](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K081294.md) | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Jul 29, 2008 | SESE | | [K071002](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K071002.md) | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | Jun 21, 2007 | SESE | | [K070626](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K070626.md) | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | May 4, 2007 | SESE | | [K071017](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K071017.md) | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | Siemens Medical Solutions Diagnostics | May 2, 2007 | SESE | | [K062924](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K062924.md) | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | Dade Behring, Inc. | Dec 26, 2006 | SESE | | [K063057](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K063057.md) | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | Dec 22, 2006 | SESE | | [K061802](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K061802.md) | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH | Dade Behring, Inc. | Sep 11, 2006 | SESE | | [K060369](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K060369.md) | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | Dade Behring, Inc. | May 4, 2006 | SESE | | [K053603](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K053603.md) | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | Roche Diagnostics Corp. | Feb 9, 2006 | SESE | | [K053109](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K053109.md) | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Dec 23, 2005 | SESE | | [K051564](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K051564.md) | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH | Olympus America, Inc. | Aug 22, 2005 | SESE | | [K042485](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K042485.md) | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | Roche Diagnostics Corp. | Oct 29, 2004 | SESE | | [K041799](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K041799.md) | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | Aug 25, 2004 | SESE | | [K041668](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K041668.md) | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Aug 19, 2004 | SESE | | [K033908](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD/K033908.md) | N HIGH SENSITIVITY CRP | Dade Behring, Inc. | Jan 22, 2004 | SESE | ## Top Applicants - Dade Behring, Inc. — 5 clearances - Siemens Healthcare Diagnostics, Inc. — 2 clearances - Roche Diagnostics Corp. — 2 clearances - Olympus America, Inc. — 2 clearances - Beckman Coulter, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NQD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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