510(k) K040101
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2004
- Date Received
- January 20, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- IM
- Submission Type
The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.