(488 days)
GlucoSure STAR meter and test strips, Contrex Plus glucose control solutions
YSI reference instrument
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities. The performance studies focus on accuracy, precision, and equivalence to predicate devices, not on AI/ML model performance.
No.
The device is a diagnostic tool used to measure glucose levels, aiding in monitoring diabetes, but it does not treat or cure the condition.
No
The MEG-2 Blood Glucose Monitoring System and MEG-2 Multi Blood Glucose Monitoring System are explicitly stated as "not indicated for the diagnosis or screening of diabetes." They are intended for monitoring glucose levels as an aid to managing Diabetes Mellitus.
No
The device description explicitly states that the system consists of a "meter, test strips and three levels of control solution," which are physical hardware components. The performance studies also include testing of hardware aspects like "Battery Life verification," "Test Strip Holder Life verification," "Drop testing," and "EMC and Electrical Safety testing."
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This phrase is a clear indicator that the device is intended for in vitro diagnostic purposes.
N/A
Intended Use / 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, 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.
Product codes
CGA, NBW, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MEG-2 Blood Glucose Monitoring System/MEG-2 Blood Glucose Test Strips: lay use by people with diabetes, single patient use, at home.
MEG-2 Multi Blood Glucose Monitoring System/MEG-2 Multi Blood Glucose Test Strips: healthcare professionals, multiple patients, clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Testing was conducted as follows: Software verification and validation plus software integration testing, Battery Life verification, Test Strip Holder Life verification, Control Solution Qualification, Control solution real-time and use-life stability testing, Drop testing, EMC and Electrical Safety testing, Linearity testing, Precision testing, Hematocrit range testing, Interference testing, test strip stability testing, test strip open bottle use life testing, and testing 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 with 141 test subjects. Blood testing was done by healthcare professionals and non-professional self-testers against the YSI reference instrument. Control solution testing was also conducted. Results demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GlucoSure STAR meter and test strips, Contrex Plus glucose control solutions
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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AUG 3 1 2011
510(k) Summary
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| Submitter: | Hsue-mei Lee
Manager of Quality Assurance Department
Apex BioTechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN)
email: hsue-mei@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hsue-mei Lee
Manager of Quality Assurance Department
Apex BioTechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN)
email: hsue-mei@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Date Prepared: | August 18, 2011 |
| Trade Names: | MEG-2 Blood Glucose Monitoring System, MEG-2 Blood Glucose Test
Strips, MEG-2 Glucose Control Solutions, MEG-2 Multi Blood Glucose
Monitoring System, MEG-2 Multi Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II
Single (Specified) Analyte Controls (Assayed And Unassayed), 21 CFR
862.1660, Class I, reserved |
| Product Codes: | CGA, NBW, JJX |
| Predicate Devices: | GlucoSure STAR meter and test strips
Contrex Plus glucose control solutions |
| Device Description: | 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. |
| 510(k) Summary (Continued) | |
| Intended 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, 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 | |
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510(k) Summary (Continued)
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510(k) Summary (Continued)
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| Comparison of
Technological
Characteristics: | The MEG-2 meter uses the same test algorithm as the predicate. The meter
has been modified from a 4-button system to a 3-button one with a new
battery type. The test strip and test strip holder have been modified to allow
automatic detection of the calibration code upon insertion of the test strip.
The core functionality of the predicate meter has been retained in the MEG-2
meter. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The MEG-2 Multi meter and MEG-2 Multi test strips are identical to their
MEG-2 counterparts except for labeling to distinguish that they are for
professional use (MEG-2 Multi) and home use (MEG-2), respectively. |
| | The MEG-2 control solutions have the same formula as the predicate with
the addition of a red dye and slight adjustment of the glucose values for each
level of control solution. |
| Non-Clinical
Testing: | Testing was conducted as follows: Software verification and validation plus
software integration testing, Battery Life verification, Test Strip Holder Life
verification, Control Solution Qualification, Control solution real-time and
use-life stability testing, Drop testing, EMC and Electrical Safety testing,
Linearity testing, Precision testing, Hematocrit range testing, Interference
testing, test strip stability testing, test strip open bottle use life testing, and
testing 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 with
141 test subjects. Blood testing was done by healthcare professionals and
non-professional self-testers against the YSI reference instrument. Control
solution testing was also conducted. Results demonstrate substantial
equivalence to the predicate device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the MEG-2 and MEG-2
Multi systems (meters, test strips and control solutions) perform in a
substantially equivalent manner to that of the predicate. We conclude that
the MEG-2 and MEG-2 Multi meters, test strips and control solutions are
substantially 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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Page 2 -
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
5
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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