(127 days)
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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic tool for measuring blood glucose levels, intended to aid in monitoring diabetes control rather than directly treating or preventing disease.
No
The device is not indicated for the diagnosis or screening of diabetes. It is intended for monitoring glucose levels as an aid in managing diabetes control programs.
No
The device description explicitly states that the system consists of a "meter" and "test strips," which are hardware components.
Yes, both the MEG-2B Blood Glucose Monitoring System and the MEG-2B Pro Blood Glucose Monitoring System are IVDs (In Vitro Diagnostics).
This is explicitly stated in the "Intended Use / Indications for Use" section for both systems:
- MEG-2B Blood Glucose Monitoring System: "This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared."
- MEG-2B Pro Blood Glucose Monitoring System: "It is intended for testing outside the body (in vitro diagnostic use)."
The definition of an IVD is a medical device used to examine specimens taken from the body, such as blood, for the purpose of providing information for diagnosis, monitoring, or screening. These systems fit this definition as they measure glucose in blood samples outside the body to aid in monitoring diabetes control.
N/A
Intended Use / Indications for Use
The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for serecting of diabetes or for neonatal use.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meter and MEG-2B Test Strips. It is used for testing of blood glucose by self-testers at home. The MEG-2B Pro Blood Glucose Monitoring System consists of the MEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The MEG-2B and MEG-2B Pro systems are identical other than trade names and details of product labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, or palm
Indicated Patient Age Range
Not indicated for neonatal use.
Intended User / Care Setting
MEG-2B Blood Glucose Monitoring System: lay people with diabetes at home, self-testing.
MEG-2B Pro Blood Glucose Monitoring System: professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Disinfection (viral inactivation) and "robustness" testing were done to qualify all recommended disinfection solutions. Results demonstrate substantial equivalence to the predicate.
Clinical Testing: No clinical testing was conducted.
Conclusion: Testing showed that the modified MEG-2B and MEG 2B Pro Blood Glucose Monitoring Systems are substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MEG-2B Blood Glucose Monitoring System (K120448), MEG-2B Pro Blood Glucose Monitoring System (K120448)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
APEX BIO TECHNOLOGY CORP HSUE-MEI LEE, MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7. LI-HSIN ROAD V May 7, 2015 HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN
Re: K143750
Trade/Device Name: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: April 2, 2015 Received: April 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Katherine Serrano -S
For : 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143750
Device Name
MEG-2B Blood Glucose Monitoring System
Indications for Use (Describe)
The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantiative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143750
Device Name
MEG-2B Pro Blood Glucose Monitoring System
Indications for Use (Describe)
The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). This system is indicated for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not indicated for serecting of diabetes or for neonatal use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| 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 | March 31, 2015 |
| Trade Names | MEG-2B Blood Glucose Monitoring System
MEG-2B Pro Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | MEG-2B Blood Glucose Monitoring System (K120448)
MEG-2B Pro Blood Glucose Monitoring System (K120448) |
| Device Description | The MEG-2B Blood Glucose Monitoring System consists of the MEG-2B meter
and MEG-2B Test Strips. It is used for testing of blood glucose by self-testers
at home. The MEG-2B Pro Blood Glucose Monitoring System consists of the
MEG-2B Pro meter and MEG-2B Pro Test Strips. It is used for testing of blood
glucose by professional testers in healthcare facilities. The MEG-2B and MEG-
2B Pro systems are identical other than trade names and details of product
labeling. |
5
510(k) Summary (Continued)
| Intended Use | MEG-2B Blood Glucose Monitoring System: The MEG-2B Blood Glucose Monitoring
System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is
intended for the quantitative measurement of glucose in fresh capillary whole blood samples
drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during
steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people
with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is
intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is
not indicated for the diagnosis or screening of diabetes or for neonatal use.
MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose
Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood
Glucose Test Strip, is intended for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should
be done only during steady -state times (when glucose is not changing rapidly). This system is
indicated for multiple-patient use in professional healthcare settings as an aid to monitor the
effectiveness of diabetes control programs. It is only used with single-use, auto-disabling
lancing device. It is intended for testing outside the body (in vitro diagnostic use). It is not
indicated for the diagnosis or screening of diabetes or for neonatal use. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The modified MEG-2B and MEG 2B Pro Blood Glucose Monitoring Systems are
identical to the predicate other than a) addition of silver paint to the meter case, b)
change in manufacturing site for the LCD cover, and c) the recommendation of three
additional disinfectants in the User Manuals. |
| Non-Clinical
Testing | Disinfection (viral inactivation) and "robustness" testing were done to qualify all
recommended disinfection solutions. Results demonstrate substantial equivalence to
the predicate. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified MEG-2B and MEG 2B Pro Blood Glucose
Monitoring Systems are substantially equivalent to the predicate. |
.