(447 days)
The TD-4239 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared. The TD-4239 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The TD-4239 Blood Glucose Test Strips are for use with the TD-4239 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
The TD-4239 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4239 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel. The system is only used with single-use, auto-disabling lancing devices. The TD-4239 Multi Blood Glucose Test Strips are for use with the TD-4239 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System consist 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. Use only TD-4239 and TD-4239 Multi test strips for the TD-4239 and TD-4239 Multi Blood Glucose Monitoring Systems, and use with the control solutions that has been tested and validated with this system to perform quality checks. The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH). The two blood glucose systems have the same technical components (same meter and test strips) and therefore the same performance data.
Acceptance Criteria and Device Performance for TD-4239 Blood Glucose Monitoring System
This report summarizes the acceptance criteria and performance of the TD-4239 Blood Glucose Monitoring System, based on the provided 510(k) summary.
Note: The provided document is a 510(k) summary, which typically provides a high-level overview of performance studies rather than detailed raw data or exhaustive statistical analysis. Therefore, some information requested might not be explicitly stated or may require interpretation from the given context.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "Accuracy study and software validation were performed to evaluate the meter performance" and that "Results show that both devices are substantially equivalent to the predicate device K094005." This implies that the acceptance criteria are based on demonstrating equivalence to the predicate device's established accuracy and performance.
While specific numerical acceptance criteria (e.g., % within ±15 mg/dL or ±15%) are not explicitly listed in the provided text, blood glucose monitoring systems typically adhere to ISO 15197 standards or equivalent FDA-recognized guidance documents. The claim of "satisfactory performance" and "substantial equivalence" suggests that these industry-standard accuracy criteria were met.
For the purpose of this response, we infer the acceptance criteria based on standard expectations for blood glucose meters seeking FDA clearance.
| Acceptance Criteria (Inferred from industry standards and claim of substantial equivalence) | Reported Device Performance (Summary statement) |
|---|---|
| Accuracy (Typically ISO 15197 related): A high percentage of results (e.g., ≥95%) within a specified range compared to a laboratory reference method. For example: |
- Within ±15 mg/dL for blood 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.