NJV

Test, Albumin Cobalt Binding

Product code

NJV

Device name

Test, Albumin Cobalt Binding

Device class

Class 2

21 CFR

21 CFR 862.1215

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

Definition text from the FDA device classification database (U.S. federal government work, public domain).