(292 days)
The FreeStyle 3 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle 5 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Flash Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Freedom Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
A chemistry change has been made to the FreeStyle Blood Glucose Test Strip. The modified strip is to be marketed under the brand name, FreeStyle, and is intended for use with the following Blood Glucose Monitoring Systems: FreeStyle 3 Blood Glucose Monitoring System, FreeStyle 5 Blood Glucose Monitoring System, FreeStyle Flash Blood Glucose Monitoring System, FreeStyle Freedom Blood Glucose Monitoring System. The meters and other system components contained within these systems have not been modified. Each of the aforementioned blood glucose monitoring systems are comprised of a handheld glucose meter, glucose reagent test strips, a quality control solution, a lancing device, lancets, lancing cap, and labeling for performing a blood glucose test. The intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry. The systems utilize coulometric biosensor technology to quantitatively measure glucose concentration in whole blood samples. The systems are intended for selfmonitoring of glucose in capillary whole blood. The primary users are persons with diabetes. The systems are meant to aid in diabetes management and for healthcare professionals to aid in monitoring the effectiveness of diabetes treatment. The FreeStyle Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. When the strip is touched to a blood drop, the sample chamber on the strip fills by capillary action. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, or palm or upper arm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 15 seconds, or 5 seconds). The internal volume of the test strip is precisely controlled, and a blood glucose result will not be displayed on the meter unless the internal sample chamber is filled. Once the measurement begins, the glucose is rapidly oxidized by the reagents that are present in the inside of the sample chamber. The electrochemical signal that results from this process depends only on the total amount of glucose present. The reagent chemistry enables electrolysis of glucose in the blood sample. A mediator molecule shuttles electrons rapidly between a glucose-oxidizing enzyme and the working electrode on the strip. The mediator is capable of reacting rapidly with both the electrode and the enzyme, resulting in a fast reaction time and minimizing the total amount of mediator required. The small mediator load results in high accuracy at the low end of the glucose measurement range.
Regulatory Submission Type: 510(k) Premarket Notification
Device: FreeStyle Blood Glucose Test Strips (chemistry change) for use with FreeStyle 3, FreeStyle 5, FreeStyle Flash, and FreeStyle Freedom Blood Glucose Monitoring Systems.
Acceptance Criteria and Device Performance:
The provided document describes modifications to the FreeStyle Blood Glucose Test Strip, specifically a chemistry change. However, it does not explicitly state acceptance criteria or present a table of device performance against such criteria. The document focuses on describing the technical changes to the test strip and the regulatory approval process (510(k) clearance) based on substantial equivalence to predicate devices.
Therefore, the requested table cannot be created from the provided text. The submission implies that the performance of the modified strips, in conjunction with the existing meters, is intended to be substantially equivalent to the predicate devices, which would have met specific accuracy and precision standards for blood glucose monitoring systems.
Information Not Present in the Document:
The following information, relevant to a study proving device meets acceptance criteria, is not provided in the given 510(k) summary:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This is generally not applicable to a blood glucose meter, which is a standalone measurement device rather than an AI-assisted diagnostic imaging tool).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (Again, not directly applicable in the sense of an AI algorithm, but the device itself is a standalone measurement system).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any performance studies.
- The sample size for the training set. (Training sets are not typically discussed for this type of device unless there's a machine learning component for a novel analytical method, which isn't detailed here beyond the biosensor chemistry).
- How the ground truth for the training set was established.
Summary of Device and Changes:
The submission details a chemistry change to the FreeStyle Blood Glucose Test Strips. The enzyme has been changed from GDH-PQQ with nPBI mediator to GDH-FAD with MAP mediator. This change is noted to address potential interference from carbohydrates like maltose, lactose, and galactose, which could be an issue with GDH-PQQ. Other modifications include a new adhesive system for the spacer tape, a change in the source of carbon ink, and an altered physical appearance of the test strip for visual distinction. The meters themselves, and their underlying software algorithms, have not been modified.
Conclusion:
This 510(k) summary focuses on demonstrating substantial equivalence based on technical modifications to a component (the test strip) of an existing cleared system. It describes the changes to the device but does not include the detailed performance data or study design elements requested, which would typically be found in a separate section of a full regulatory submission. The clearance indicates that the FDA found the modified device to be as safe and effective as the predicate devices, implying that any necessary performance testing would have been conducted and met established standards, even if not explicitly detailed in this summary.
§ 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.