(362 days)
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.
The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.
Here's an analysis of the acceptance criteria and supporting studies for the SuperCheck Plus Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are not explicitly stated in a single consolidated table in the document, but rather described in the text, referencing ISO 15197 for precision and generally implying agreement with a reference method (YSI 2300) for overall system accuracy. The document states that the system "met the acceptance criteria" without detailing the specific criteria for system accuracy (e.g., percentage within a certain range). For precision, ISO 15197 is mentioned, which typically has performance targets based on CV (Coefficient of Variation) or absolute differences. I will infer based on the stated performance.
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Precision | ||
| Repeatability Precision (within-run) | ||
| Glucose |
§ 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.