Myeloperoxidase, Immunoassay, System, Test
The Myeloperoxidase Immunoassay Test System is designed to measure myeloperoxidase (MPO) concentrations in human plasma and is intended for use in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain who are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. It is an FDA Class 2 device regulated under 21 CFR 866.5600 in the Immunology specialty, reviewed by the Clinical Toxicology panel, with product code NTV, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
Basic Information
- Product Code
- NTV
- Device Class
- FDA class 2
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071474 | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | Dec 10, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K050029 | CARDIOMPO TEST | May 10, 2005 | Substantially Equivalent | Prognostix, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.