(148 days)
The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
The Accu-Chek Guide System consists of the following:
- Accu-Chek Guide meter
- Accu-Chek Guide test strips
- Accu-Chek Guide control solutions (previously cleared in K043474)
The Accu-Chek Guide Blood Glucose Monitoring System makes use of the Accu-Chek Guide test strips, the Accu-Chek Guide meter, and the Accu-Chek Guide control solutions. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. It should be noted that the Accu-Chek Guide control solutions are identical to the Accu-Chek Aviva control solutions that were cleared previously in K043474. The name has simply been updated to reflect their use with the Accu-Chek Guide system.
The provided document describes the ACCU-CHEK Guide Blood Glucose Monitoring System and its performance. However, it does not involve an AI or algorithmic device in the context of medical imaging or diagnosis. Instead, it concerns a blood glucose meter, a device that performs a direct chemical measurement. Therefore, many of the requested categories, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set," are not applicable as they relate specifically to AI/ML or image interpretation studies.
Here's a breakdown of the relevant information from the document regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems are generally based on accuracy standards, often requiring a certain percentage of results to fall within specified variations from a reference method. The document provides performance data based on differences from a reference measurement. The provided data is not explicitly labeled as "acceptance criteria," but rather as "user performance data." However, these percentages directly describe how well the device performs against established accuracy thresholds. I will present the provided performance data as demonstrating how the device met implied or industry-standard acceptance levels for accuracy.
| Performance Category | Acceptance Criteria (Implied/Industry Standard) | Reported Device Performance |
|---|---|---|
| User Performance - Fingertip (Capillary Blood) | ||
| Glucose concentration |
§ 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.