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

The RTube Exhaled Breath Condensate collection system is the principal system in the United States. Exhaled Breath Condensate collection is increasingly employed for clinical investigation in the United States. We recommend using one of the following codes:

• A specific Category III CPT code number 0140T for "Exhaled Breath Condensate pH" has been approved and published as of July 2005. This is specific to the collection of condensate for analysis of pH.
• CPT code 94250, which is for "Expired gas collection, quantitative, single procedure (separate procedure)" is a reasonable general-purpose code for non-pH EBC collections.
• Additionally CPT Code 94799 may be useful: "Unlisted pulmonary service or procedure"

There is no guarantee that any 3rd party insurance will pay for these codes.

We will update this site with new information regarding CPT code status and insurance reimbursement issues as needed.

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)