NQD · Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Immunology · 21 CFR 866.5270 · Class 2
Overview
| Product Code | NQD |
|---|---|
| Device Name | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control |
| Regulation | 21 CFR 866.5270 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 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 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | Apr 2, 2026 | SESE |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | Jan 18, 2024 | SESE |
| K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | Dec 16, 2022 | SESE |
| K173833 | CRP Vario | SENTINEL CH. SpA | Sep 27, 2018 | SESE |
| K081294 | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Jul 29, 2008 | SESE |
| K071002 | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | Beckman Coulter, Inc. | Jun 21, 2007 | SESE |
| K070626 | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | May 4, 2007 | SESE |
| K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | Siemens Medical Solutions Diagnostics | May 2, 2007 | SESE |
| K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | Dade Behring, Inc. | Dec 26, 2006 | SESE |
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | Dec 22, 2006 | SESE |
| K061802 | 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 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | Dade Behring, Inc. | May 4, 2006 | SESE |
| K053603 | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS | Roche Diagnostics Corp. | Feb 9, 2006 | SESE |
| K053109 | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Dec 23, 2005 | SESE |
| K051564 | 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 | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) | Roche Diagnostics Corp. | Oct 29, 2004 | SESE |
| K041799 | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | Aug 25, 2004 | SESE |
| K041668 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Aug 19, 2004 | SESE |
| K033908 | N HIGH SENSITIVITY CRP | Dade Behring, Inc. | Jan 22, 2004 | SESE |
Top Applicants
- Dade Behring, Inc. — 5 clearances
- Beckman Coulter, Inc. — 2 clearances
- Olympus America, Inc. — 2 clearances
- Roche Diagnostics Corp. — 2 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
