NOE
8 FDA 510(k) clearances · Product code
155 daysmedian time to decision
290 days90th percentile
8clearances measured
FDA profile
- Official device name
- Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5600
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Diazyme PLAC® Test for Lp-PLA2 Activity (K203136) | Diazyme Laboratories, Inc. | 2021-08-06 |
| PLAC TEST FOR LP-PLA2 ACTIVITY (K141575) | Diadexus, Inc. | 2014-12-15 |
| PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (K101853) | Diadexus, Inc. | 2011-01-03 |
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |
| DIADEXUS PLAC TEST (K050523) | Diadexus, Inc. | 2005-06-15 |
| MODIFICATION TO DIADEXUS PLAC TEST (K040101) | Diadexus, Inc. | 2004-02-05 |
| DIADEXUS PLAC TEST (K030477) | Diadexus, Inc. | 2003-07-18 |
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Every clearance here is in the API, with alerts when new ones post.