CE Mark

The RTube™ is CE Marked under the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79 EC). Declaration of Conformity (PDF) UK Filing 10-03 (PDF) UK Filing 10-03 IVD (PDF) Indoor Authorized Rep Status (PDF)

CPT Code

New CPT Code 83987 pH; Exhaled Breath Condensate has been published in the 2010 AMA CPT Coding Guide and as of January 1, 2010 is reimbursed by Medicare. For more information on the clinical use of this new laboratory test please click here.

FDA Regulatory Status of the RTube family of products

RTube is registered with the United States Food and Drug Administration as a Class I device for the collection of expired gas. The proprietary gas-standardized pH assay, when performed by Respiratory Research, Inc., is considered a "home brew" assay. The RTube and gas-standardized pH assay, if used for the purpose of differentiating Acid Reflux-induced respiratory symptoms from airway inflammation, and used in accordance with the protocol for the RTube Breath Test, together comprise a diagnostic allowed for clinical use in the management of patients with respiratory disease.

Thus, the RTube can be incorporated into most clinical investigations in the United States, as well as into the broader management of patients.

This of course does not mean it is exempt from individual entity's Institutional Review Board or Human Investigation Committee. For research protocols, each individual Institutional Review Board/ Human Investigation Committee may wish to make its own determination as to the non-significant risk nature of the device, especially if the device is modified or incorporated into other equipment such as ventilator circuits.

Institutional Review Board/ Human Investigation Committee Consideration of the RTube family of products

Over 40,000 samples have been collected with the RTube. Our device and methods have been considered non-significant risk by multiple Institutional Review Boards. Each individual Institutional Review Board/ Human Investigation Committee may wish to make its own determination as to the non-significant risk nature of the device, especially if the device is modified or incorporated into other equipment such as ventilator circuits. An example of an IRB decision agreeing with the non-significant risk nature of the device is presented below as reference material to facilitate your discussions with your IRB.

• Letter from IRB attesting to non-significant risk nature of the RTube collection system (PDF)