(352 days)
The GAL-1C 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.
The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C 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.
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
The GAL-1C blood glucose meter and GAL-1C test strips used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions for quality control testing
The GAL-1C Blood Glucose Monitoring System is intended for quantitative measurement of glucose in fresh capillary whole blood samples. The acceptance criteria and details of the studies conducted are as follows:
1. Table of Acceptance Criteria & Reported Device Performance:
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the GAL-1C Blood Glucose Monitoring System against a pre-defined standard (e.g., ISO 15197). Instead, it states that "Results demonstrate substantial equivalence to the predicate device meter, test strips, and control solutions." and "Clinical and non-clinical testing demonstrated that the GAL-1C system performs in a substantially equivalent manner to that of the predicate system."
However, the non-clinical and clinical testing sections list various parameters that were evaluated, which implicitly serve as performance indicators contributing to the substantial equivalence claim. Since quantitative acceptance criteria are not explicitly stated, I will list the areas of testing performed.
| Acceptance Criteria (Implied) | Reported Device Performance and Study Type |
|---|---|
| Non-Clinical Testing: | |
| Software Verification and Validation | Conducted: Software verification and validation results demonstrated substantial equivalence. |
| Software Integration | Conducted: Software integration results demonstrated substantial equivalence. |
| Linearity | Conducted: Linearity results demonstrated substantial equivalence. |
| Lo/Hi Detection | Conducted: Lo/Hi detection results demonstrated substantial equivalence. |
| Drop Testing | Conducted: Drop testing results demonstrated substantial equivalence. |
| EMC and Electrical Safety | Conducted: EMC and Electrical Safety results demonstrated substantial equivalence. |
| Strip Non-interchangeability (new vs. predicate) | Conducted: Verification of strip noninterchangeability between new and predicate devices results demonstrated substantial equivalence. |
| Precision | Conducted: Precision results demonstrated substantial equivalence. |
| Interferences | Conducted: Interferences results demonstrated substantial equivalence. |
| Minimum Sample Volume | Conducted: Minimum sample volume results demonstrated substantial equivalence. |
| Altitude | Conducted: Altitude results demonstrated substantial equivalence. |
| Hematocrit | Conducted: Hematocrit results demonstrated substantial equivalence. |
| Humidity and Temperature | Conducted: Humidity and temperature results demonstrated substantial equivalence. |
| Control Solution Qualification | Conducted: Control solution qualification results demonstrated substantial equivalence. |
| Environmental Conditions Testing | Conducted: Environmental conditions testing results demonstrated substantial equivalence. |
| Test Strip Shelf Life and Use Life | Conducted: Test strip shelf life and use life results demonstrated substantial equivalence. |
| Control Solution Shelf Life and Use Life | Conducted: Control solution shelf life and use life results demonstrated substantial equivalence. |
| Battery Life Testing | Conducted: Battery life testing results demonstrated substantial equivalence. |
| Disinfection Effectiveness (accuracy post-disinfection) | Conducted: Disinfection testing showed that the system remained accurate after multiple disinfections to simulate a lifetime of treatments. |
| Disinfectant Material Ability to Inactivate Hepatitis B | Conducted: Evaluation was done to demonstrate the ability of the selected disinfectant material to inactivate Hepatitis B. |
| Clinical Testing: | |
| Accuracy (Healthcare Professionals) | Conducted: An accuracy study was performed with blood testing by healthcare professionals. Results demonstrated substantial equivalence. |
| User Performance (Self-testing at Finger, Palm, Forearm) | Conducted: A User Performance study was conducted with self-testing at finger, palm, and forearm sites. Results demonstrated substantial equivalence. |
| Ease-of-Use and Ease-of-Understanding of User's Manual (User Study) | Conducted: A User Study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual. Results demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size used for the clinical accuracy study or the user performance study. It only mentions that an "accuracy study was performed" and a "User Performance study was conducted."
The country of origin for the data and whether the studies were retrospective or prospective are not specified in the provided 510(k) summary. Given the submitter's location (Hsinchu, CHINA (TAIWAN)), it's plausible the studies were conducted there, but this is not confirmed.
3. 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):
For the accuracy study, it states "An accuracy study was performed with blood testing by healthcare professionals." The number of healthcare professionals and their specific qualifications are not specified. For glucose monitoring systems, "healthcare professionals" typically refer to phlebotomists, nurses, or lab technicians performing comparative measurements against a gold standard laboratory method. The document does not mention "experts" in the sense of adjudicators for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe an adjudication method for establishing ground truth, as it relates to expert consensus for image interpretation. For glucose meters, the "ground truth" is typically established by a laboratory reference method (e.g., YSI analyzer) against which the device's readings are compared.
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 to this device. The GAL-1C Blood Glucose Monitoring System is a self-testing blood glucose meter, not an imaging device that would typically involve human readers or AI assistance. No MRMC study was mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a blood glucose monitoring system, and its "standalone" performance refers to the device itself providing a reading. The accuracy study (performed by healthcare professionals) and user performance study (self-testing) both evaluate the device's standalone performance in producing glucose measurements. The "algorithm" in this context is the internal processing of the meter to convert the electrochemical signal from the test strip into a glucose reading. Therefore, the accuracy data from these studies represent the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For blood glucose meters, the ground truth is typically established by a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose measurements from venous plasma or whole blood. While not explicitly stated, this is the standard ground truth for such devices. The statement "An accuracy study was performed with blood testing by healthcare professionals" implies a comparison to a more accurate reference method.
8. The sample size for the training set:
Blood glucose monitoring systems like the GAL-1C historically do not use "training sets" in the context of machine learning algorithms that require large datasets for model development. While the system has "meter software," the development process of such software typically involves engineering design, calibration, and verification/validation, rather than machine learning training. Therefore, no "training set" in the machine learning sense is referenced or implied.
9. How the ground truth for the training set was established:
As there is no mention of a machine learning "training set," the method for establishing its ground truth is not applicable and therefore not described. The ground truth for the calibration of the device and test strips would have been established through controlled laboratory experiments using reference methods.
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. SEP 1 5 2011
| 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: | September 13, 2011 |
| Trade Names: | GAL-1C Blood Glucose Monitoring SystemGAL-1C Blood Glucose Test StripsContrex Plus III Glucose Control Solution |
| Classification: | Glucose test system, 21 CFR 862.1345, Class IISingle (specified) analyte controls (assayed and unassayed), 21 CFR862.1660, Class I |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoSure STAR Blood Glucose Monitoring System (K073648)Contrex Plus Glucose Control Solution (100747) |
| Device Description: | The GAL-1C blood glucose meter and GAL-1C test strips used fortesting of blood glucose by self-testers at home with Contrex Plus IIIGlucose Control Solutions for quality control testing |
| Intended Use: | The GAL-1C 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 onlyduring steady-state (when glucose is not changing rapidly). Testing is done outsidethe body (In Vitro diagnostic use). It is indicated for lay use by people withdiabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be usedby a single patient and it should not be shared. It is not indicated for the diagnosis orscreening of diabetes or for neonatal use.The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C BloodGlucose Meter to quantitatively measure glucose in capillary whole blood takenfrom fingertips, palm, or forearm. Alternative site testing should be performed onlyduring steady-state (when glucose is not changing rapidly). They are not indicatedfor the diagnosis or screening of diabetes or for neonatal use.The purpose of the control solution test is to validate the performance of the BloodGlucose Monitoring System using a testing solution with a known range of glucose.A control test that falls within the acceptable range indicates the user's technique isappropriate and the test strip and meter are functioning properly. |
| Comparison ofTechnologicalCharacteristics: | The GAL-IC meter uses the same test algorithm as the predicate meter. TheGAL-1C meter has been modified by changing 4 operating buttons to 3operating buttons. Meter software has been changed to accommodate thenew autocoding feature. The test strip holder has been modified to allowautomatic detection of the calibration code upon insertion of the test strip.The test strip chemistry has been slightly modified and the blood collectionchamber has been reduced in volume. The Contrex Plus III Control Solutionincludes an added red dye and slightly modified glucose concentrations. |
| Non-ClinicalTesting: | Testing was conducted as follows: Software verification and validation,software integration, linearity, Lo/Hi detection, drop testing, EMC andElectrical Safety, verification of strip noninterchangeability between new andpredicate devices, precision, interferences, minimum sample volume,altitude, hematocrit, humidity and temperature, control solution qualification,environmental conditions testing, test strip shelf life and use life, controlsolution shelf life and use life, and battery life testing. Disinfection testingwas done to show that the system remained accurate after multipledisinfections to simulate a life time of disinfection treatments. Evaluationwas done to demonstrate the ability of the selected disinfectant material toinactive Hepatitis B. Results demonstrate substantial equivalence to thepredicate device meter, test strips, and control solutions. |
| Clinical Testing | An accuracy study was performed with blood testing by healthcareprofessionals. A User Performance study was conducted with self-testing atfinger, palm, and forearm sites. A User Study was conducted to evaluateease-of-use of the system and ease-of-understanding of the User's Manual.Results demonstrate substantial equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the GAL-1C systemperforms in a substantially equivalent manner to that of the predicate system.We conclude that the GAL-1C meter and GAL-1C test strips aresubstantially equivalent to the predicate devices. |
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510(k) Summary (Continued)
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three lines that resemble human figures, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Apex BioTechnology Corporation c/o IIsue-mei Lee Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 China (Taiwan)
SEP 15 2011
Re: K102816
GAL-1C Blood Glucose Monitoring System, GAL-1C Blood Glucose Test Trade/Device Name: Strips, and Contrex Plus III Glucose Control Solutions Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: August 22, 2011 Received: August 23, 2011
Dear Sir/Madam
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 nust comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807). Iabeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcessorYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K102816
Device Name: GAL-IC Blood Glucose Monitoring System
Indications for Use:
GAL-1C Blood Glucose Monitoring System:
The GAL-1C 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 1 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-1C Blood Glucose Test Strips:
The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C 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.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K102816
Page 1 of 2
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Indications for Use Statement
510(k) Number (if known): K102816
Device Name: Contrex Plus III Glucose Control Solutions
Indications for Use:
Intended use
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Over-The-Counter Use X = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K102816
Page 2 of 2
§ 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.