← Product Code [MXA](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA) · DEN030001

# NIOX ARTICLE NO: 02-1000 (DEN030001)

_Aerocrine AB · MXA · Apr 30, 2003 · Clinical Toxicology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/DEN030001

## Device Facts

- **Applicant:** Aerocrine AB
- **Product Code:** [MXA](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA.md)
- **Decision Date:** Apr 30, 2003
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 862.3080
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/DEN030001](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MXA/DEN030001)

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