(787 days)
The FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.
The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).
Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).
The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).
The provided text describes the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System, a device for measuring glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood. It is a 510(k) summary, therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study for a novel device.
Based on the provided information, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:
Key Takeaway: The document primarily focuses on non-clinical and clinical "studies" to demonstrate performance characteristics and compare them to predicate devices, rather than a single, large-scale comparative effectiveness study with human readers (MRMC). The "acceptance criteria" are implied by the performance characteristics tested and similarity to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in a table within the provided text. Instead, the document discusses "performance criteria were met" and that the device "met design specifications and requirements." The "acceptance criteria" are implied by meeting the established ranges and performance levels comparable to the predicate devices.
However, the "performance" is reported through the summary of testing. Since this is a 510(k) submission, the primary "performance" shown is that the device is substantially equivalent to the predicate devices. The listed similarities and differences in characteristics serve as the de facto "reported device performance."
| Performance Characteristic/Acceptance Criterion (Implied) | Device Performance (FORA ADVANCED GD40) | Notes |
|---|---|---|
| Glucose Measurement | ||
| Intended Use | Same as Predicate: quantitative measurement in fresh capillary whole blood from the finger to monitor effectiveness of diabetes control program. Not for diagnosis/screening. | Demonstrated equivalence. |
| Setting | Over-the-counter Home use. | Same as Predicate. |
| Test Range | 20 – 600 mg/dL. | Same as Predicate. |
| Sample Type | Fingertip Capillary whole blood. | Same as Predicate. |
| Sample Volume | 0.9 μl. | Same as Predicate. |
| Test Time | 5 sec. | Same as Predicate. |
| Calibration | Automatic. | Same as Predicate. |
| Operating Principle | Enzymatic (Glucose Dehydrogenase). | Same as Predicate. |
| Data storage | 1000 Results with Date/Time. | Same as Predicate. |
| Weight | 71 g. | Same as Predicate. |
| Non-Clinical Performance (Precision, Linearity, Interference, Flex, Disinfection, Robustness) | Met design specifications and requirements. | Confirmed via design verification and validation testing. Specific numerical results are not provided in this summary. |
| Clinical Performance (System Accuracy, Operation, Ease of Use) | Confirmed. | Confirmed via user evaluation. Specific numerical results or study methodology (e.g., sample size, metrics) not provided in this summary. |
| β-Ketone Measurement | ||
| Intended Use | Same as Predicate: quantitative measurement in fresh capillary whole blood from the finger to monitor effectiveness of diabetes control program. Not for diagnosis/screening. | Demonstrated equivalence. |
| Setting | Over-the-counter Home use. | Same as Predicate. |
| Test Range | 20 – 600 mg/dL (same as glucose listed in table, but typical ketone ranges are different, likely copied from glucose for tabular similarity, the actual range for β-Ketone would be specified in detailed report). | Needs clarification as this range is for glucose. β-Ketone measurements are based on B-hydroxybutyrate dehydrogenase. However, the document clearly states the β-Ketone test system is 'Class I, meets the limitations of exemption 21 CFR 862.9(c)(5)', implying minimal testing required for equivalence assuming the core technology (test strips and control solutions) are the same as the predicate (K161738), as stated in Device Description section E. |
| Non-Clinical Performance | Met design specifications and requirements. | Confirmed via design verification and validation testing. Specific numerical results are not provided in this summary. The glucose/ß-ketone test strips and control solutions are stated to be "the same as the predicate," which simplifies the testing needed to demonstrate substantial equivalence for these analytes. |
| Clinical Performance | Confirmed. | Confirmed via user evaluation. |
| Cholesterol Measurement | ||
| Intended Use | Same as Predicate: diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism. | Demonstrated equivalence. |
| Setting | Over-the-counter Home use. (Predicate: Over-the-counter Home use and Prescription use). | Difference noted: Proposed device is only OTC Home use, while predicate was also Prescription use. This is a narrowing of intended use, which is generally acceptable for substantial equivalence. |
| Test Range | 100 – 400 mg/dL. | Same as Predicate. |
| Sample Type | Fingertip Capillary whole blood. | Same as Predicate. |
| Sample Volume | 5 μl. (Predicate: 10 μl) | Difference noted: Lower sample volume on the proposed device. This is typically viewed as an improvement, but would have been supported by specific performance data in the full submission. |
| Test Time | 60 sec. (Predicate: |
§ 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.