Breath Hydrogen/Methane Testing

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Hi, Is anyone familiar with the QuinTron BreathTracker SC analyzer? Our GI clinic using it for hydrogen and methane breath testing (e.g., lactose, fructose, sucrose, and SIBO testing).
I’m trying to understand how this is classified from a regulatory standpoint, specifically whether this is considered a lab test under CLIA and, if so, what complexity category it falls under. I haven’t been able to find clear guidance. Thanks in advance

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Breath is considered an in-vivo sample and does not fall under CLIA regulations.

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Don't know how accurate the AI Google is for this but here is what I found.

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Khanh Nguyen
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