NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Class II
FDA product code NQD covers "Cardiac C-Reactive Protein, Antigen, Antiserum, And Control", a Class II medical device regulated under 21 CFR 866.5270. Submissions are reviewed by the Immunology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQD
- Device Class
- Class II
- Regulation Number
- 866.5270
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260026 | roche diagnostics | Tina-quant Cardiac high sensitivity CRP III | April 2, 2026 |
| K233242 | siemens healthcare diagnostics | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | January 18, 2024 |
| K212559 | siemens healthcare diagnostics products | CardioPhase® hsCRP | December 16, 2022 |
| K173833 | sentinel ch | CRP Vario | September 27, 2018 |
| K081294 | siemens healthcare diagnostics | ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRA | July 29, 2008 |
| K071002 | beckman coulter | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP | June 21, 2007 |
| K070626 | beckman coulter | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT | May 4, 2007 |
| K071017 | siemens medical solutions diagnostics | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 | May 2, 2007 |
| K062924 | dade behring | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | December 26, 2006 |
| K063057 | diagnostic products corporation | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | December 22, 2006 |
| K061802 | dade behring | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, | September 11, 2006 |
| K060369 | dade behring | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | May 4, 2006 |
| K053603 | roche diagnostics | C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUME | February 9, 2006 |
| K053109 | dade behring | DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE | December 23, 2005 |
| K051564 | olympus america | OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC | August 22, 2005 |
| K042485 | roche diagnostics | TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE | October 29, 2004 |
| K041799 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KI | August 25, 2004 |
| K041668 | olympus america | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | August 19, 2004 |
| K033908 | dade behring | N HIGH SENSITIVITY CRP | January 22, 2004 |