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The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

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The provided document is a 510(k) clearance letter for the Acon On Call Diabetes Management Software. This document does not contain specific acceptance criteria, study details, or performance data typically associated with a clinical validation study for a medical device's performance metrics.

The letter primarily focuses on:

• Confirming the FDA's review of the premarket notification.
• Stating the device is substantially equivalent to legally marketed predicate devices.
• Listing regulatory information such as product codes, regulation numbers, and regulatory class.
• Outlining the general controls provisions of the Act and reminding the manufacturer of compliance requirements.
• Providing contact information for regulatory guidance.
• Including the "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, a separate document detailing the clinical study or performance validation would be needed, which is not part of this 510(k) clearance letter.

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