(139 days)
The ForaCare GD20 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm and upper arm.). It is intended for use by a single person and should not be shared.
The ForaCare GD20 Blood Glucose Monitoring System is intended for self-testing use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes, or for testing of neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The ForaCare GD20 test strips are for use with the ForaCare GD20 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.
The system consists 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.
Here's a breakdown of the acceptance criteria and study information for the ForaCare GD20 Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the ForaCare GD20 Blood Glucose Monitoring System meets the minimum acceptable accuracy required by EN ISO 15197 and the recommendation of FDA guidance for both clinical accuracy with capillary blood from the fingertip and consumer performance.
| Acceptance Criteria | Reported Device Performance (ForaCare GD20) |
|---|---|
| Minimum acceptable accuracy required by EN ISO 15197 | Met |
| Recommendation of FDA guidance | Met |
Note: The specific numerical targets for accuracy (e.g., within X% of reference method, or Y% of results within specific zones) for EN ISO 15197 or FDA guidance are not detailed in this summary. It only states that the device "met" these requirements.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for either the "Clinical Accuracy study with capillary blood from the fingertip" or the "Consumer Performance Study."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study abstract refers to a "Clinical Accuracy study with capillary blood from the fingertip" and a "Consumer Performance Study," implying they were conducted as part of the validation process, but details on their prospective or retrospective nature are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the given text. For blood glucose monitoring systems, the "ground truth" (reference method) is typically established by laboratory-grade instruments, not human experts in the same way it would be for imaging diagnostics. The text only mentions "Clinical Accuracy study with capillary blood from the fingertip" and "Consumer Performance Study," which would involve comparing the device's readings against a reference method.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. Adjudication methods (like 2+1, 3+1) are usually relevant for expert-based assessments (e.g., radiology reads), not typically for quantitative measurements like blood glucose where the ground truth is often from an independent, highly accurate instrument.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study (involving human readers and AI assistance) is for diagnostic imaging or similar applications where human interpretation is a primary component. This device is a blood glucose monitoring system, which performs a direct quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone performance assessment was effectively done. The "Clinical Accuracy study with capillary blood from the fingertip" and "Consumer Performance Study" evaluate the device's (meter + strip) performance in measuring glucose independently against a reference method. While users interact with the device, the core "performance" being assessed is the accuracy of the glucose measurement itself, which is largely an algorithmic/chemical process.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The text implies that the ground truth for glucose measurement was established using a reference method or laboratory-grade instrument. For blood glucose, this typically involves a YSI glucose analyzer or a similar highly accurate laboratory method. The document states "comparison of system accuracy performance," which inherently means comparison to a more accurate reference.
8. The Sample Size for the Training Set:
- Not provided. The document describes performance studies (accuracy, precision, consumer studies) but does not detail a separate training set or its size. For a blood glucose monitoring system, the "training" for the device would typically occur during its development and calibration phases, rather than explicitly an "AI training set" in the common sense.
9. How the Ground Truth for the Training Set Was Established:
- Not provided. As with the training set size, the specifics of how the ground truth was established for any internal development/calibration are not mentioned in this regulatory 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.