(276 days)
The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in 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 lancing devices.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use.
The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips
GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of:
- (1) Glucose Meter
- (2) Glucose Test Strips
- (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985.
- (4) Check Strip
- (5) Instruction for use
[Test Principle]
The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use.
[Control Solution]
The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2).
[Check Strip]
The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover.
[Device Calibration]
The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.
This 510(k) summary provides limited details regarding the specifics of the clinical study, making it challenging to fully address all requested information. However, based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states compliance with ISO 15197:2003. This standard defines acceptance criteria for blood glucose monitoring systems. While the specific numerical acceptance criteria from the standard are not explicitly listed in this document, the submission claims that "the predetermined acceptance criteria were fully met." Without access to the full study report or the ISO 15197:2003 standard, the exact numerical performance metrics for the device against specific thresholds cannot be detailed.
Acceptance Criteria (Based on ISO 15197:2003 Claims):
| Performance Metric | Acceptance Criteria (from ISO 15197:2003, implied to be met) | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003 | "the predetermined acceptance criteria were fully met." |
| Precision | Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003 | "the predetermined acceptance criteria were fully met." |
| Other | Not explicitly detailed in the provided text, but implied as met per ISO 15197:2003 | "the predetermined acceptance criteria were fully met." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided 510(k) summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submission is from a Taiwan-based company, which might suggest data could originate from Taiwan or other regions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not explicitly stated in the provided 510(k) summary. For blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer), not necessarily by "experts" in the same way as image interpretation.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense for blood glucose monitoring systems. The "ground truth" is typically a quantitative measurement from a reference method, rather than a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not relevant or typically performed for blood glucose monitoring systems. These studies are common for diagnostic imaging devices where human interpretation plays a significant role.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the device (GoodLife CS-200 Blood Glucose Monitoring System) is a standalone system. Its performance is measured directly by comparing its readings to a reference method, without human intervention in the result generation or interpretation. The submission states, "The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor." This describes a standalone, automated measurement.
7. The Type of Ground Truth Used
The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a glucose analyzer, often a YSI analyzer), which provides a highly accurate and precise measurement of blood glucose. While not explicitly stated as "YSI" in this document, the industry standard for studies supporting ISO 15197 compliance relies on such reference methods. This falls under the category of reference standard/laboratory measurement.
8. The Sample Size for the Training Set
Not applicable and not typically mentioned for this type of device. Blood glucose meters do not usually involve a "training set" in the context of machine learning algorithms that learn from data. The device's calibration and algorithm are developed through engineering and chemical principles, not machine learning training. The "calibration" mentioned ("The device is calibrated by Digital Code Strip...") refers to a specific operational calibration for each batch of test strips, not a machine learning training process.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there isn't a "training set" in the machine learning sense for this device. The device's design, chemical reagents, and electrochemical principles are developed and validated against known glucose concentrations and reference methods during its R&D phase, but this is not framed as establishing ground truth for a "training set."
§ 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.