(488 days)
MEG-2 Blood Glucose Monitoring System: The MEG-2 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. 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. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Blood Glucose Test Strips: The MEG-2 Blood Glucose Test Strips are to be used with the MEG-2 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). The MEG-2 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
MEG-2 Glucose Control Solution: The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
MEG-2 Multi Blood Glucose Monitoring System: The MEG-2 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. Testing is done outside the body (In Vitro diagnostic use). It is indicated to be use 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. Alternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Multi Blood Glucose Test Strips: The MEG-2 Multi Blood Glucose Test Strips are to be used with the MEG-2 Multi Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). It is 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 device.
The MEG-2 blood glucose monitoring system consists of a meter, test strips and three levels of control solution. It is used for testing of blood glucose by self-testers at home.
The MEG-2 Multi blood glucose monitoring system consists of a meter, test strips and three levels of control solution. It is used for testing of blood glucose by professional testers in healthcare facilities.
Here's a breakdown of the acceptance criteria and the study details for the MEG-2 Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that "Results demonstrate substantial equivalence to the predicate devices." For non-clinical testing, the conclusion is that "Results demonstrate substantial equivalence to the predicate devices." For clinical testing, it states "Results demonstrate substantial equivalence to the predicate device."
To extract inferred acceptance criteria and reported performance, we rely on the general statement of "substantial equivalence" and the type of tests performed, which are standard for blood glucose monitoring systems. Regulatory bodies like the FDA expect accuracy comparable to a predicate device and within clinically acceptable limits (e.g., ISO 15197 guidelines, although not explicitly mentioned here, are commonly referenced).
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Accuracy (Clinical): Performance comparable to the predicate device and within acceptable accuracy standards for blood glucose monitoring systems. | "Results demonstrate substantial equivalence to the predicate device." (Implied: High accuracy against YSI reference). |
| Linearity: Measurements are accurate across the entire reportable range. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Precision: Consistent and reproducible results. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Hematocrit Range: Accurate measurements across a range of hematocrit levels. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Interference: Not significantly affected by common interfering substances. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Software Verification & Validation: Software functions correctly and reliably. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Battery Life: Acceptable battery performance. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Test Strip Holder Life: Test strip holder maintains functionality over its expected lifespan. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Control Solution Qualification & Stability: Control solutions perform as expected and maintain stability. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Drop Testing: Device withstands typical physical impacts. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| EMC and Electrical Safety: Device meets electromagnetic compatibility and electrical safety standards. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Test Strip Stability & Open Bottle Use Life: Test strips maintain accuracy over their shelf life and after opening. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
| Test Strip Autocode Manufacturing & QC: Autocode functionality and quality control are robust. | Testing was conducted. "Results demonstrate substantial equivalence to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 141 test subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It mentions the submitter's location as Hsinchu, CHINA (TAIWAN), but this doesn't confirm where the clinical data was collected. It is a prospective study implied by "An Accuracy and User Performance Evaluation study was conducted with 141 test subjects. Blood testing was done by healthcare professionals and non-professional self-testers against the YSI reference instrument."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth was established against a YSI reference instrument, which is a laboratory-grade glucose analyzer considered a gold standard for blood glucose measurement. Therefore, no human experts directly "established" the ground truth in the sense of consensus reading. The YSI instrument itself serves as the expert/reference.
- The study involved "healthcare professionals" and "non-professional self-testers," who used the device, but their role was in performance evaluation, not ground truth establishment for the glucose values.
4. Adjudication Method (for the test set)
- Not applicable as the ground truth was established by comparison to a YSI reference instrument, which provides a definitive numerical result, rather than by human expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a traditional MRMC comparative effectiveness study was not explicitly described for human readers with and without AI assistance. This device is a blood glucose meter, not an AI-powered diagnostic imaging tool.
- The study looked at user performance (healthcare professionals vs. self-testers) with the device, not the improvement of human readers assisted by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, in essence, the "Accuracy and User Performance Evaluation study" included a standalone performance aspect. The device's measurements (algorithm output) were compared directly to the YSI reference instrument. While human users operated the device, the core evaluation was of the device's ability to accurately measure glucose, which means evaluating the integrated algorithm and sensor.
- The non-clinical testing, such as linearity, precision, hematocrit, and interference testing, also directly evaluates the algorithm's performance in a controlled, standalone manner.
7. The Type of Ground Truth Used
- Objective Reference Method / Laboratory Gold Standard: The ground truth for the clinical study was established using a YSI reference instrument. This is a widely accepted, highly accurate laboratory method for measuring blood glucose.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" or its sample size. This suggests that the MEG-2 system likely does not utilize a machine learning algorithm that requires a distinct training phase in the same way typical AI/ML medical devices do. Instead, the device uses a "test algorithm" that is presumably based on established electrochemical principles, potentially with calibration data, rather than being "trained" on a large dataset of patient results.
- The comparison states: "The MEG-2 meter uses the same test algorithm as the predicate." This further supports the idea that it's relying on a pre-existing, established algorithm rather than a newly trained one.
9. How the Ground Truth for the Training Set Was Established
- As no distinct "training set" is mentioned for a machine learning algorithm, this question is not directly applicable. If an internal calibration or development dataset was used for the "test algorithm," the method of establishing ground truth for that would likely also be against a reference method like YSI or similar lab assays, but this detail is not provided.
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AUG 3 1 2011
510(k) Summary
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| 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: | August 18, 2011 |
| Trade Names: | MEG-2 Blood Glucose Monitoring System, MEG-2 Blood Glucose TestStrips, MEG-2 Glucose Control Solutions, MEG-2 Multi Blood GlucoseMonitoring System, MEG-2 Multi Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class IISingle (Specified) Analyte Controls (Assayed And Unassayed), 21 CFR862.1660, Class I, reserved |
| Product Codes: | CGA, NBW, JJX |
| Predicate Devices: | GlucoSure STAR meter and test stripsContrex Plus glucose control solutions |
| Device Description: | The MEG-2 blood glucose monitoring system consists of a meter, teststrips and three levels of control solution. It is used for testing of bloodglucose by self-testers at home.The MEG-2 Multi blood glucose monitoring system consists of a meter,test strips and three levels of control solution. It is used for testing ofblood glucose by professional testers in healthcare facilities. |
| 510(k) Summary (Continued) | |
| Intended Use:MEG-2 Blood Glucose Monitoring System: The MEG-2 Blood GlucoseMonitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips, forearm, or palm. Testingis done outside the body (In Vitro diagnostic use). It is indicated for lay use bypeople with diabetes, as an aid to monitoring levels in Diabetes Mellitus and shouldonly be used by a single patient. This system should not be shared. It is notindicated for the diagnosis or screening of diabetes or for neonatal use. Alternativesite testing can be used only during steady-state blood glucose conditions.MEG-2 Blood Glucose Test Strips: The MEG-2 Blood Glucose Test Strips are tobe used with the MEG-2 Blood Glucose Meter to quantitatively measure glucose incapillary whole blood taken from fingertips, palm, or forearm. It is for use outsideof the body (in vitro diagnostic use). The MEG-2 Blood Glucose MonitoringSystems are plasma-calibrated for easy comparison to lab results. They are intendedfor lay use by people with diabetes and should only be used by a single patient.This system should not be shared. They are not indicated for the diagnosis orscreening of diabetes or for neonatal use.MEG-2 Glucose Control Solution: The MEG-2 Glucose Control Solutions are usedwith the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicateappropriate user technique and to indicate that the test strip and meter arefunctioning properly..MEG-2 Multi Blood Glucose Monitoring System: The MEG-2 Multi BloodGlucose Monitoring System is intended for the quantitative measurement of glucosein fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.Testing is done outside the body (In Vitro diagnostic use). It is indicated to be usefor multiple patients in a clinical setting by healthcare professionals, as an aid tomonitoring 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 ofdiabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions.MEG-2 Multi Blood Glucose Test Strips: The MEG-2 Multi Blood Glucose TestStrips are to be used with the MEG-2 Multi Blood Glucose Meter; it measuresglucose in capillary whole blood taken from a fingertip, palm, or forearm. It is foruse outside of the body (in vitro diagnostic use). It is indicated in a clinical setting tobe used for multiple patients by healthcare professionals. This system is only usedwith single-use auto-disabling lancing device |
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510(k) Summary (Continued)
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510(k) Summary (Continued)
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| Comparison ofTechnologicalCharacteristics: | The MEG-2 meter uses the same test algorithm as the predicate. The meterhas been modified from a 4-button system to a 3-button one with a newbattery type. The test strip and test strip holder have been modified to allowautomatic detection of the calibration code upon insertion of the test strip.The core functionality of the predicate meter has been retained in the MEG-2meter. |
|---|---|
| The MEG-2 Multi meter and MEG-2 Multi test strips are identical to theirMEG-2 counterparts except for labeling to distinguish that they are forprofessional use (MEG-2 Multi) and home use (MEG-2), respectively. | |
| The MEG-2 control solutions have the same formula as the predicate withthe addition of a red dye and slight adjustment of the glucose values for eachlevel of control solution. | |
| Non-ClinicalTesting: | Testing was conducted as follows: Software verification and validation plussoftware integration testing, Battery Life verification, Test Strip Holder Lifeverification, Control Solution Qualification, Control solution real-time anduse-life stability testing, Drop testing, EMC and Electrical Safety testing,Linearity testing, Precision testing, Hematocrit range testing, Interferencetesting, test strip stability testing, test strip open bottle use life testing, andtesting of the test strip autocode manufacturing and quality control processes.Results demonstrate substantial equivalence to the predicate devices. |
| Clinical Testing | An Accuracy and User Performance Evaluation study was conducted with141 test subjects. Blood testing was done by healthcare professionals andnon-professional self-testers against the YSI reference instrument. Controlsolution testing was also conducted. Results demonstrate substantialequivalence to the predicate device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the MEG-2 and MEG-2Multi systems (meters, test strips and control solutions) perform in asubstantially equivalent manner to that of the predicate. We conclude thatthe MEG-2 and MEG-2 Multi meters, test strips and control solutions aresubstantially equivalent to their predicate. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 3 1 2011
Apex BioTechnology Corporation c/o Hsue-mei Lee Manager of Quality Assurance Department No. 7 Li-Hsin Road V, Hsinchu Science Park Hsinchu, China (Taiwan) 30078
Re: K101204
Trade Name: MEG-2 Blood Glucose Monitoring System, MEG-2 Multi Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: August 19, 2011 Received: August 22, 2011
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 Mav 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, thereforc, 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.
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 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/MedicalDevicesforYou/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
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Indications for Use Statement
510(k) Number (if known): K101204
Device Name: MEG-2 Blood Glucose Monitoring System
Indications for Use:
MEG-2 Blood Glucose Monitoring System:
The MEG-2 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, 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. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Atternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Blood Glucose Test Strips:
The MEG-2 Blood Glucose Test Strips are to be used with the MEG-2 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screenng of diabetes or for neonatal use.
MEG-2 Glucose Control Solution:
The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K101204
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Indications for Use Statement
510(k) Number (if known): K101204
Device Name: MEG-2 Multi Blood Glucose Monitoring System
MEG-2 Multi Blood Glucose Monitoring System:
The MEG-2 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. Testing is done outside the body (In Vitro diagnostic use). It is indicated to be use 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. Alternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Multi Blood Glucose Test Strips:
The MEG-2 Multi Blood Glucose Test Strips are to be used with the MEG-2 Multi Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). It is 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 device.
Prescription Use Over-The-Counter 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)
Richie Glenn Coffey
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K101204
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§ 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.