Test, Albumin Cobalt Binding
The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic device used on human serum that detects Ischemia Modified Albumin (IMA) by measuring the cobalt-binding capacity of albumin, intended for use in conjunction with ECG and cardiac troponin as an aid to short-term risk stratification of patients presenting with chest pain of suspected cardiac origin. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJV and regulation 21 CFR 862.1215 in the Clinical Chemistry specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.
Research product code NJV in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NJV
- Device Class
- FDA class 2
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.