(152 days)
The Genesis Health Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper-arm. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
This system is intended to be used by a single person and should not be shared.
The Genesis Health Technologies test strips are for use with the Genesis Health Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.
The alternative site testing in the Genesis Health Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The Genesis Health Technologies control solutions are for use with the Genesis Health Blood Glucose meter and test strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:
The provided text describes a 510(k) submission for a blood glucose monitoring system. Crucially, it does not provide explicit acceptance criteria with specific numerical thresholds for accuracy, nor does it detail a standalone study proving the device meets new acceptance criteria.
Instead, the submission for the Genesis Health Technologies Blood Glucose Monitoring System (model TD-4123) is based on demonstrating substantial equivalence to a predicate device, the U-RIGHT TD-4252 Blood Glucose Monitoring System (K101631). This means the focus of the "study" described is to show that the new device performs similarly or identically to an already approved device, rather than meeting a new, independently established set of performance targets.
Therefore, the table and other information below are derived from the available information, noting the absence of certain details that would be present in a submission proving performance against novel acceptance criteria.
1. Table of Acceptance Criteria (Implied by Substantial Equivalence to Predicate) and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate device that the new device aims to match. The "reported device performance" is the claim that the new device performs equivalently based on comparative testing.
| Acceptance Criteria (Implied from Predicate Device) | Reported Device Performance (Genesis Health Technologies Blood Glucose Monitoring System) |
|---|---|
| Intended use: Quantitative measurement of glucose in fresh capillary whole blood (finger, palm, forearm, upper arm) for diabetes control, not for diagnosis/screening or neonates. | Same as predicate (stated: "Same as predicate") |
| Detection mechanism: Electrochemical Biosensor technology | Same as predicate (stated: "Same as predicate") |
| Detection method: Amperometry (measuring current from chemical reaction) | Same as predicate (stated: "Same as predicate") |
| Sample volume: 0.7 µL | Same as predicate (stated: "Same as predicate") |
| Reaction time: 7 seconds | Same as predicate (stated: "Same as predicate") |
| Measurement range: 20-600 mg/dL | Same as predicate (stated: "Same as predicate") |
| Temperature compensation: Automatic with built-in thermister | Same as predicate (stated: "Same as predicate") |
| Strip Ejection: Yes | Same as predicate (stated: "Same as predicate") |
| Power saving: Auto turn-off after 3 minutes without action | Same as predicate (stated: "Same as predicate") |
| Calibration: No coding required | Same as predicate (stated: "Same as predicate") |
| Alarm Function: 4 settings | Same as predicate (stated: "Same as predicate") |
| Memory feature: 450 measurements with day and time | Same as predicate (stated: "Same as predicate") |
| Test strip enzyme: Glucose dehydrogenase | Same as predicate (stated: "Same as predicate") |
| Test strip detection method: Amperometry | Same as predicate (stated: "Same as predicate") |
| Test strip blood volume: 0.7 µL | Same as predicate (stated: "Same as predicate") |
| Test strip reaction time: 7 Sec | Same as predicate (stated: "Same as predicate") |
| Meter Storage/Transportation condition: -4 to 140 (-20~60), |
§ 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.