NOE · Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Immunology · 21 CFR 866.5600 · Class 2
Overview
| Product Code | NOE |
|---|---|
| Device Name | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | Aug 6, 2021 | SESE |
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Diadexus, Inc. | Dec 15, 2014 | SESE |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Diadexus, Inc. | Jan 3, 2011 | SESE |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Diadexus, Inc. | Dec 20, 2007 | SESE |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | Sep 11, 2006 | SESE |
| K050523 | DIADEXUS PLAC TEST | Diadexus, Inc. | Jun 15, 2005 | SESE |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | Feb 5, 2004 | SESE |
| K030477 | DIADEXUS PLAC TEST | Diadexus, Inc. | Jul 18, 2003 | SESE |
Top Applicants
- Diadexus, Inc. — 7 clearances
- Diazyme Laboratories, Inc. — 1 clearance
