510(k) K023824
K023824 is an FDA 510(k) premarket notification submitted by Ischemia Technologies, Inc. for the device "ALBUMIN COBALT BINDING TEST (ACB TEST)". The FDA issued a decision of SESU on February 14, 2003. The device falls under product code NJV (Test, Albumin Cobalt Binding), a Class II device regulated under 21 CFR 862.1215.
Clearance Details
- Decision
- SESU ()
- Decision Date
- February 14, 2003
- Date Received
- November 18, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Albumin Cobalt Binding
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type
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.