510(k) K053196
K053196 is an FDA 510(k) premarket notification submitted by Inverness Medical Innovations, Inc. for the device "ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)". The FDA issued a decision of Substantially Equivalent on December 16, 2005. The device falls under product code NJV (Test, Albumin Cobalt Binding), a Class II device regulated under 21 CFR 862.1215. Inverness Medical Innovations, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2005
- Date Received
- November 16, 2005
- Clearance Type
- Special
- 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.