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) → NTV — Myeloperoxidase, Immunoassay, System, Test

# NTV · Myeloperoxidase, Immunoassay, System, Test

_Immunology · 21 CFR 866.5600 · Class 2_

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

## Overview

- **Product Code:** NTV
- **Device Name:** Myeloperoxidase, Immunoassay, System, Test
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K071474](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NTV/K071474.md) | DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 | Siemens Healthcare Diagnostics | Dec 10, 2008 | SESE |
| [K050029](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NTV/K050029.md) | CARDIOMPO TEST | Prognostix, Inc. | May 10, 2005 | SESE |

## Top Applicants

- Siemens Healthcare Diagnostics — 1 clearance
- Prognostix, Inc. — 1 clearance

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

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