NOE — Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 Class II
FDA product code NOE covers "Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2", a Class II medical device regulated under 21 CFR 866.5600. Submissions are reviewed by the Immunology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NOE
- Device Class
- Class II
- Regulation Number
- 866.5600
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203136 | diazyme laboratories | Diazyme PLAC® Test for Lp-PLA2 Activity | August 6, 2021 |
| K141575 | diadexus | PLAC TEST FOR LP-PLA2 ACTIVITY | December 15, 2014 |
| K101853 | diadexus | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0 | January 3, 2011 |
| K072599 | diadexus | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109, | December 20, 2007 |
| K062234 | diadexus | MODIFICATION TO DIADEXUS PLAC TEST | September 11, 2006 |
| K050523 | diadexus | DIADEXUS PLAC TEST | June 15, 2005 |
| K040101 | diadexus | MODIFICATION TO DIADEXUS PLAC TEST | February 5, 2004 |
| K030477 | diadexus | DIADEXUS PLAC TEST | July 18, 2003 |