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Biosense Modifies Urinalysis App To Comply With FDA

The app developer unveiled its plans to comply with FDA regulations for its uChek urinalysis app, including the submission of a 510(k) for the full-feature product and launch of a Lite version. FDA sent a letter to Biosense questioning its earlier launch of the app without a 510(k) after an article ran in “The Gray Sheet” assessing its regulatory status.

Mumbai, India-based app developer Biosense Technologies says it is submitting a 510(k) for the full-feature version of its uChek urinalysis app for iPhone in response to FDA scrutiny. In the meantime, it has launched a new version of the app lacking certain testing features.

The company unveiled its plans to comply with FDA regulations July 20.

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