(189 days)
The FOCUS Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.
FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm.
FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.
The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-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 sing-use, auto-disabling lancing devices. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.
FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood taken from the fingertip or forearm.
FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.
The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are comprised of glucose reagent test strips using glucose dehydrogenase flavin-adenine dinucleotide chemistry (GDH-FAD), a portable hand-held electronic meter and glucose control solutions.
The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are identical and include identical components (test strips, meter, control solutions), differing only in name to identify the intended user of the system. The FOCUS Blood Glucose Monitoring System is intended for single-patient use (self-testing) and the FOCUS Pro Blood Glucose Monitoring System is intended for multi-patient use (healthcare professional user).
When a user inserts a test strip into the meter, the meter turns on. While the test strip is in the meter, the user obtains a blood or glucose control sample, and then applies the sample to the test strip by touching the test strip to the sample. When an adequate amount of sample has been applied to the test strip, the meter emits an audible beep (when this feature is selected by the user) and the test begins. The meter's liquid crystal display (LCD) shows a test is in process by counting down from the number 4. When the test is complete, the meter displays the glucose result. Blood glucose results are plasma-calibrated to facilitate comparison to standard laboratory methods of blood glucose measurement.
The Blood Glucose Meter is a handheld device powered by one 3-volt nonrechargeable lithium battery. The meter includes a Test Port for insertion of a single test strip, an LCD display, a test strip release button, and buttons to navigate through menu choices. Meter operation is self-prompting using three user interface buttons. In addition to measuring glucose, the Meter also stores blood glucose and control solution results. The Meter offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. A "battery low" warning alerts the user to change the batteries. Battery charge information is available on the "Meter status screen". The user can select the auto shutoff option to conserve power when the Meter is not in use. Test data and Meter setup information will be stored in a non-volatile form to prevent data loss.
Meter Power Supply: The meter uses single volt (3V) lithium, non rechargeable battery (# CR2032). Theoretical battery life is approximately 1 year or 1000 tests, when testing is performed three times per day.
No-Coding System. The user is not required to enter a test strip lot-specific Calibration Code into the meter by pressing a button or by inserting a Code Key. FOCUS and FOCUS Pro test strips are assigned only one code and this single code is used for all strip lots.
Glucose Control Solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other nonreactive ingredients (dye). They contain no products of human origin. There are three leveis of controls, (Levels 1, 2 and 3).
When a control solution sample is applied to the FOCUS or FOCUS Pro test strip, the meter automatically detects and identifies the glucose control sample using an impedance measurement while performing the glucose measurement. After identifying the sample as control solution, the meter marks the result with the control solution icon and stores the marked result in the meter memory. All control results are excluded from the glucose patient result average calculations.
The FOCUS and FOCUS Pro Blood Glucose Monitors measure glucose electrochemically as described in the Nova One Glucose Monitor System (K122435). In the same manner, the magnitude of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.
The provided text is a 510(k) summary for the FOCUS Blood Glucose Monitoring System and FOCUS Pro Blood Glucose Monitoring System. It describes the devices, their intended use, and compares them to a predicate device. However, it does not contain specific details about acceptance criteria, performance studies with detailed results, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The "Performance Studies" section only states: "The performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory and in Human Factors testing by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." This is a very high-level summary and doesn't provide the requested granular details.
Therefore, I cannot fully complete the table and answer all questions based on the provided text. I will fill in what can be inferred or explicitly stated.
Acceptance Criteria and Device Performance
Since specific acceptance criteria and detailed performance metrics (accuracy, precision, etc.) are not provided in the summary, this section cannot be fully completed. The summary only generally states that "lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements."
| Acceptance Criteria (e.g., Accuracy, Precision) | Reported Device Performance |
|---|---|
| Not specified in provided text | Substantially equivalent to current methods for blood glucose measurements (general statement) |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The summary only mentions "laboratory and Human Factors testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. This device measures glucose quantitatively, and the "ground truth" would typically refer to a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images. The summary does not provide details of the reference method used or the personnel operating it.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This concept is typically relevant for subjective interpretation tasks (like image review) where multiple experts might disagree. For a quantitative measurement device, the "adjudication" would be related to comparing device readings against a recognized reference method. No specific methodology for this comparison is detailed beyond the general statement of "substantially equivalent."
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging tool that would involve human readers interpreting cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that it measures glucose directly and provides a quantitative result. Its performance is measured as the accuracy and precision of these direct measurements. The summary states "performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory," which implies standalone testing of the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Laboratory Method: For blood glucose monitors, the ground truth is typically established by comparative measurements against a highly accurate reference laboratory instrument, such as a YSI glucose analyzer. While not explicitly stated, this is the standard for such devices. The summary mentions "plasma-calibrated to facilitate comparison to standard laboratory methods of blood glucose measurement."
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The sample size for the training set:
- This is not an AI/Machine Learning device that would have a distinct "training set." The system's calibration and development would be based on internal development data, but it's not described in terms of a machine learning training set.
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How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML device with a separate training set in that context. The "ground truth" for calibrating and developing the device would likely be established using reference laboratory methods, similar to the test set, but specific details are not provided.
§ 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.