Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5600](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5600) → NOE — Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

# NOE · Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

_Immunology · 21 CFR 866.5600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE

## Overview

- **Product Code:** NOE
- **Device Name:** Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- **Regulation:** [21 CFR 866.5600](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5600)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K203136.md) | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | Aug 6, 2021 | SESE |
| [K141575](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K141575.md) | PLAC TEST FOR LP-PLA2 ACTIVITY | Diadexus, Inc. | Dec 15, 2014 | SESE |
| [K101853](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K101853.md) | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Diadexus, Inc. | Jan 3, 2011 | SESE |
| [K072599](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K072599.md) | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Diadexus, Inc. | Dec 20, 2007 | SESE |
| [K062234](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K062234.md) | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | Sep 11, 2006 | SESE |
| [K050523](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K050523.md) | DIADEXUS PLAC TEST | Diadexus, Inc. | Jun 15, 2005 | SESE |
| [K040101](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K040101.md) | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | Feb 5, 2004 | SESE |
| [K030477](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE/K030477.md) | DIADEXUS PLAC TEST | Diadexus, Inc. | Jul 18, 2003 | SESE |

## Top Applicants

- Diadexus, Inc. — 7 clearances
- Diazyme Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NOE)

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