(42 days)
The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly)
The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
It is for in vitro diagnostic use only. The On Call® Express Mobile Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.
The On Call® Express Blood Glucose Test Strips are used with the On Call® Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
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The provided document is a 510(k) premarket notification letter from the FDA regarding a blood glucose monitoring system. This type of document does not contain the detailed study information typically found in a clinical study report or a 510(k) summary, which would elaborate on acceptance criteria and performance data.
Therefore, I cannot extract the information required to answer your request about acceptance criteria and study details. The document is primarily a regulatory approval letter stating substantial equivalence to a predicate device.
To address your request, I would need a different type of document, such as:
- A 510(k) Summary: These summaries often contain a section describing the device's performance data and comparison to the predicate.
- A detailed clinical study report or technical file: These would include the specific design of the study, acceptance criteria, sample sizes, ground truth establishment, and adjudicated results.
The current document only provides the following, which is not sufficient for your request:
- Device Name: On Call Express Mobile Blood Glucose Monitoring System
- Regulation Name: Glucose test system
- Regulation Number: 21 CFR 862.1345
- Regulatory Class: Class II
- Product Code: NBW
- Indications for Use: Quantitative detection of glucose in fresh capillary whole blood for diabetics at home, with alternate testing sites (forearm and palm) during steady-state times. Not for diagnosis/screening of diabetes or use on neonates. For in vitro diagnostic use only. For single patient use.
§ 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.