(318 days)
The GAL-1F 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 blood glucose 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.
The GAL-1F Pro 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 blood glucose levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-1F blood glucose monitoring system consists of the GAL-1F meter and GAL-1F Test Strips. It is used for testing of blood glucose by self-testers at home. The GAL-1F Pro blood glucose monitoring system consists of the GAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The GAL-1F and GAL-1F Pro systems are identical other than trade names and details of product labeling.
Here's an analysis of the acceptance criteria and study information for the GAL-1F Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, based on the description of the clinical testing, the implied acceptance criterion is substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Substantial equivalence to the predicate device (GAL-1E and GAL-1E Multi) | Demonstrated substantial equivalence to the predicate device. |
| Ease-of-Use | Substantial equivalence to the predicate device | Demonstrated substantial equivalence to the predicate device. |
| Ease-of-Understanding (of instructions for use) | Substantial equivalence to the predicate device | Demonstrated substantial equivalence to the predicate device. |
Study that Proves Device Meets Acceptance Criteria:
The study referenced is an "accuracy user study" and an "Ease-of-Use and Ease-of-Understanding (of the instructions for use) questionnaire." The conclusion states that "Clinical and non-clinical testing show that the GAL-1F / GAL-1F Pro Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for accuracy user study: 114 self-testers and an unspecified number of professional tests. 106 unaltered samples were tested by self-testers.
- Data Provenance: The document (specifically the 510(k) Summary) lists the submitter's address as "Hsinchu, 30078 CHINA (TAIWAN)". This suggests the studies were likely conducted in Taiwan. The study is referred to as "clinical testing," which typically implies prospective data collection for the purpose of a regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. This is generally not applicable to blood glucose measurements, where the reference method provides a definitive numerical value.
5. 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
This is not applicable as the device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or classification system that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone blood glucose monitoring system. The accuracy user study assesses the system's performance (meter + test strip + user interaction) against a reference, which inherently represents its "standalone" performance in its intended use environment.
7. The Type of Ground Truth Used
For the accuracy study, the ground truth for blood glucose levels would have been established by a laboratory reference method (e.g., YSI analyzer), though this is not explicitly stated in the provided text. The document refers to "unaltered samples" and "accuracy user study," which implies comparison against a highly accurate gold standard for glucose measurement.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. For a traditional blood glucose meter, the "training" (development and calibration) would involve a series of samples used to establish the meter's calibration curve. The size of this internal development dataset is not disclosed here. The provided data pertains to clinical validation/testing.
9. How the Ground Truth for the Training Set Was Established
As with the test set, if a "training set" were explicitly for calibrating the device, the ground truth would typically be established using a laboratory reference method for glucose measurement. However, as noted above, a distinct "training set" in the AI sense is not discussed for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN RD. V, HSINCHU SCIENCE PARK HSINCHU, TAIWAN, ROC
Re: K142689
Trade/Device Name: GAL-1F Blood Glucose Monitoring System. GAL-1F Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW Dated: July 7, 2015 Received: July 8, 2015
Dear Hsue-Mei Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| SEDIVALS MAMUH GHA HEATH AND SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| ndications for UseFood and Drug Administration | ee PRA Statement below.xpiration Date: January 31, 2017 |
| 510(k) Number (if knownR142689 | |
| GAL-IF Blood Glucose Monitoring SystemDevice Name | |
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| Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFFR 801 Subpart D | Dover-The-Counter Use (S) CFR 801 Suppart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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| DEPARTMENT OF HEALTH AND HUMMA SERVICESFood and Drug Administration | Form Approved: OMB No. 0810-0120piration Date: January 31, 2017 |
|---|---|
| ndications for Us | ee PRA Statement below. |
| R142689510(k) Number (if known | |
| GAL-IF Pro Blood Glucose Monitoring SystemDevice Name | |
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510(k) Summary
| Submitter | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
|---|---|
| Contact Person | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
| Date Prepared | Aug 04, 2015 |
| Trade Names | GAL-1F Blood Glucose Monitoring SystemGAL-1F Blood Glucose Test StripsGAL-1F Pro Blood Glucose MonitoringGAL-1F Pro Blood Glucose Test Strips |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | GAL-1E and GAL-1E Multi (K113547) Blood Glucose Monitoring Systems |
| Device Description | The GAL-1F blood glucose monitoring system consists of the GAL-1F meterand GAL-1F Test Strips. It is used for testing of blood glucose by self-testers athome. The GAL-1F Pro blood glucose monitoring system consists of theGAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of bloodglucose by professional testers in healthcare facilities. The GAL-1F and GAL-1F Pro systems are identical other than trade names and details of productlabeling. |
| Intended Use | The GAL-1F Blood Glucose Monitoring System is intended for the quantitativemeasurement of glucose in fresh capillary whole blood samples drawn from thefingertips, forearm, or palm. Alternative site testing should be performed only duringsteady-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 tomonitoring blood glucose levels in Diabetes Mellitus and should only be used by asingle patient and it should not be shared. It is not indicated for the diagnosis orscreening of diabetes or for neonatal use.The GAL-1F Pro Blood Glucose Monitoring System is intended for the quantitativemeasurement of glucose in fresh capillary whole blood samples drawn from thefingertips, forearm, or palm. Alternative site testing should be performed only duringsteady-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 clinicalsetting by healthcare professionals, as an aid to monitoring blood glucose levels inDiabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It isnot indicated for the diagnosis or screening of diabetes or for neonatal use. |
| Comparison ofTechnologicalCharacteristics | The GAL-1F and GAL-1F Pro meters uses the same test strip, test strip holder, and testalgorithm as the predicate. The test strip holder has been moved from the top of thepredicate meter to the bottom of the new meter and the test strip ejection mechanism ofthe predicate has been eliminated. Software has been modified to support datadownload functionality. |
| Non-ClinicalTesting | Software verification and validation, linearity and detection limit testing, EMC andElectrical Safety testing, and drop testing were done. Disinfection and "robustness”testing were done to qualify several recommended disinfection solutions. Resultsdemonstrate substantial equivalence to the predicate device. |
| Clinical Testing | An accuracy user study was performed with blood testing by 114 self-testers and withprofessional testing. 106 unaltered samples were tested by self-testers. An Ease-of-Useand Ease-of-Understanding (of the instructions for use) questionnaire wereadministered. Results demonstrate substantial equivalence to the predicate. |
| Conclusion | Clinical and non-clinical testing show that the GAL-1F / GAL-1F Pro Blood GlucoseMonitoring System perform in a substantially equivalent manner to that of thepredicate device. |
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510(k) Summary (Continued)
§ 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.