CE
Mark
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The RTube™ is CE Marked
under the Medical Device Directive (93/42/EEC) and the
In Vitro Diagnostic Directive (98/79 EC).
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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.
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