510(k) K203136
K203136 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme PLAC® Test for Lp-PLA2 Activity". The FDA issued a decision of Substantially Equivalent on August 6, 2021. The device falls under product code NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2), a Class II device regulated under 21 CFR 866.5600. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2021
- Date Received
- October 20, 2020
- 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.