NJV · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1215
Classification
FDA Product Code
NJV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1215
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.