(230 days)
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.