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U.S. Department of Health and Human Services

Product Classification

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Device test, albumin cobalt binding
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
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.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNJV
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1215
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons