(118 days)
GAL-1E Blood Glucose Monitoring System: The GAL-IE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
GAL-1E Blood Glucose Test Strips: The GAL-IE Blood Glucose Test Strips are to be used with the GAL-1E Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
GAL-1E Multi Blood Glucose Monitoring System: The GAL-1E Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
GAL-1E Multi Blood Glucose Test Strips: The GAL-IE Multi Blood Glucose Test Strips are to be used with the GAL-IE Multi Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use. They are indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing devices.
The GAL-1E blood glucose meter and GAL-1E test strips are used for testing of blood glucose. There is one version for self-testers at home and a second version ("GAL-1E Multi") for professional use. Contrex Plus III Glucose Control Solutions are used for quality control testing of the systems.
Here's a breakdown of the acceptance criteria and study information for the GAL-1E Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document summarizes an accuracy study but does not explicitly state numerical acceptance criteria in a table. It only states that the "Results demonstrate substantial equivalence to the predicate system." This implies that the performance met the expected standards for a substantially equivalent device. Without specific numerical targets, we can infer that the device's accuracy was comparable to the predicate (GAL-1C Blood Glucose Monitoring System).
A typical accuracy study for a blood glucose monitor would compare the device's readings to a laboratory reference method. Acceptance criteria often follow ISO standards (e.g., ISO 15197), which may require:
- A certain percentage of results to be within ±X mg/dL or ±Y% of the reference value.
- Error Grid Analysis (EGA) to show that a high percentage of results fall within clinically acceptable zones (A and B).
Since these specific numerical criteria and detailed performance data are not provided in the summary, we can only report the general conclusion:
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Clinically acceptable accuracy compared to reference method. | Demonstrated substantial equivalence to the predicate system (GAL-1C). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not explicitly stated. The summary mentions an "accuracy study" and "user study data" but does not provide the number of participants or samples.
- Data Provenance: Not explicitly stated. The company is based in China (Taiwan), but tests could be conducted globally. The summary does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the summary. For blood glucose monitors, the ground truth is typically established by comparing the device readings to a laboratory reference analyzer, not directly by "experts" in the context of interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the summary. Adjudication methods (like 2+1, 3+1) are typically used for subjective clinical assessments (e.g., image interpretation) where multiple experts might disagree. For objective measurements like blood glucose, the reference method provides the "ground truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned. This type of study is typically for evaluating devices that assist human readers in making clinical decisions (e.g., AI for radiology). Blood glucose meters are standalone measurement devices and do not involve human "readers" in that sense.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The "accuracy study" and "user study" mentioned relate to the standalone performance of the device in measuring blood glucose levels. The 510(k) summary explicitly states that the device was tested to demonstrate its accuracy in quantitative measurement of glucose.
7. Type of Ground Truth Used
- The summary states "An accuracy study was conducted with professional testing." For blood glucose monitors, the ground truth is established by comparison to a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. While not explicitly named, "professional testing" would imply a validated laboratory method.
8. Sample Size for the Training Set
- The provided document does not contain information about a "training set" in the context of machine learning. The GAL-1E system uses "the same test algorithm as the predicate meter," meaning the core algorithm wasn't necessarily "trained" anew for this specific submission, but rather inherited and validated. Therefore, the concept of a training set size for a machine-learning algorithm is not directly applicable or discussed here. The development of the original algorithm would have involved its own validation, but that's not part of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" for a machine learning algorithm is not directly applicable to this submission (refer to point 8), information on how its ground truth was established is not available in the provided text. The device's algorithm is described as identical to its predicate, implying its core function and associated "ground truth" establishment would have been part of the predicate's development.
§ 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.