DeviceClearance

Product code NTV— Immunology

CARDIOMPO TEST

Classification name
Myeloperoxidase, Immunoassay, System, Test
Device class
Class 2
Regulation
21 CFR 866.5600
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NTV under 21 CFR 866.5600, via openFDA

Market context for product code NTV

FDA has cleared 2 devices under product code NTV between 2005 and 2008, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTV

Recent clearances under product code NTV

Data sourced from openFDA. This site is unofficial and independent of the FDA.