FDA 510K For Breath Nitric Oxide Test System
The Breath Nitric Oxide Test System is a diagnostic device used to measure nitric oxide (NO) levels in biological samples, typically exhaled breath or blood. These systems are commonly used in clinical and research settings to assess respiratory conditions, endothelial function, and inflammatory responses.
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Breath Nitric Oxide Test System
FDA 510K for Breath Nitric Oxide Test System Device Code and Regulation Number
| S.
No |
Product Code | Device | Regulation Description | Regulation Name | Product Class |
| 1. | MXA | System, Test, Breath Nitric Oxide | Breath Nitric Oxide Test System | 862.3080 | 2 |
System, Test, Breath Nitric Oxide
Intended Use
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.
Device Description
The Breath Nitric Oxide Test System is a non-invasive, in vitro diagnostic medical device designed to quantitatively measure fractional exhaled nitric oxide (FeNO) in human breath. The system consists of a nitric oxide analyzer, a controlled breath-sampling interface with a mouthpiece, internal signal processing electronics, embedded software, and a user display. During use, the patient exhales at a regulated flow rate through the mouthpiece, allowing a breath sample to be analyzed for nitric oxide concentration using established detection technology. The measured FeNO value is automatically calculated and displayed to the user in parts per billion (ppb). The device is intended for use as an adjunct to other clinical assessments to assist healthcare professionals in evaluating airway inflammation and monitoring patient response to anti-inflammatory therapy.
Performance testing (Analytical) for Breath Nitric Oxide Test System
- Precision/Reproducibility
- Linearity
- Analytical specificity
- Interference
- Assay reportable range
- Traceability, stability, expected values (controls, calibrators, or methods)
- Detection limit
- Carry-over
Clinical Testing
No Guidance available for 510k submission