DCK · C-Reactive Protein, Antigen, Antiserum, And Control
Immunology · 21 CFR 866.5270 · Class 2
Overview
| Product Code | DCK |
|---|---|
| Device Name | 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 (20 of 126)
Showing 20 most recent of 126 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | Apr 18, 2025 | SESE |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | Nov 4, 2022 | SESE |
| K192028 | Yumizen C1200 CRP | HORIBA ABX SAS | Jun 25, 2020 | SESE |
| K192118 | CRP Vario | SENTINEL CH. SpA | Nov 8, 2019 | SESE |
| K191993 | Yumizen C1200 CRP | HORIBA ABX SAS | Oct 3, 2019 | SESE |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | Jul 14, 2017 | SESE |
| K142993 | 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 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | Sep 24, 2015 | SESE |
| K141689 | 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 | DIAZYME HSCRP POC TEST KIT | Diazyme Laboratories | Sep 21, 2012 | SESE |
| K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | Diazyme Laboratories | Apr 27, 2011 | SESE |
| K061138 | ABX PENTRA 400 : CRP | Horiba Abx | Sep 29, 2006 | SESE |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | Apr 28, 2006 | SESE |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Clinical Data, Inc. | Feb 9, 2006 | SESE |
| K050836 | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | Aug 8, 2005 | SESE |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Stanbio Laboratory | Oct 14, 2004 | SESE |
| K042442 | 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 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Genzyme Corp. | Jun 25, 2004 | SESE |
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | Cholestech Corp. | Jun 18, 2004 | SESE |
| K032663 | 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
