(52 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No
The device is intended for monitoring glucose levels, which is a diagnostic and management aid, not a therapeutic intervention.
No
The text explicitly states for both MEG-2B and MEG-2B Pro Blood Glucose Monitoring Systems that they are "not indicated for the diagnosis or screening of diabetes". Their purpose is for monitoring glucose levels as an aid to managing Diabetes Mellitus.
No
The device description explicitly mentions a "MEG-2B blood glucose meter" and "MEG-2B test strips," which are hardware components necessary for the intended use of measuring glucose in blood samples. The software is part of a system that includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "quantitative measurement of glucose in fresh capillary whole blood samples." This involves testing a biological sample (blood) outside of the body.
- Device Description: The description explicitly states that the meters and test strips are used for "testing of blood glucose."
- Components: The system includes test strips and control solutions, which are common components of IVD devices used for chemical analysis of biological samples.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood glucose monitoring system fits this definition as it measures glucose in blood samples to aid in monitoring diabetes.
N/A
Intended Use / Indications for Use
MEG-2B Blood Glucose Monitoring System: The MEG-2B 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. 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.
MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. 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.
MEG-2B Blood Glucose Test Strips: The MEG-2B Blood Glucose Test Strips are to be used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. 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-2B Pro Blood Glucose Test Strips: The MEG-2B Pro Blood Glucose Test Strips are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. 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.
MEG-2B Glucose Control Solutions: 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
The MEG-2B blood glucose meter and MEG-2B test strips are used for testing of blood glucose by self-testers at home. The MEG-2B Pro meter and strips are identical to the MEG-2B versions except they are sold with labeling oriented toward the professional user, rather than the self-testing home user. MEG-2B Glucose Control Solutions are used for quality control testing of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MEG-2B Blood Glucose Monitoring System & Test Strips: lay use by people with diabetes.
MEG-2B Pro Blood Glucose Monitoring System & Test Strips: multiple patients in a clinical setting by healthcare professionals.
MEG-2B Glucose Control Solutions: Not specified, but implied for user/healthcare professionals to validate system performance.
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: EMC and Electrical Safety, drop testing, test strip holder qualification, software verification and validation (including unit integration testing), control solution qualification, and linearity testing with validation of Lo/Hi detection. Results demonstrate substantial equivalence to the predicate system.
Clinical Testing: Not applicable.
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.
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.
Not Found
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).
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.
0
KI2OYYS
APR - 6 2012
510(k) Summary
| Submitter: | Apex Biotechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Liu
Assistant Manager of Quality Assurance Department
Apex Biotechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN)
email: lisaliu@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Date Prepared: | February 6, 2012 |
| Trade Names: | MEG-2B Blood Glucose Monitoring System
MEG-2B Pro Blood Glucose Monitoring System
MEG-2B Blood Glucose Test Strips
MEG-2B Pro Blood Glucose Test Strips
MEG-2B Glucose Control Solutions |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II
Single (specified) analyte controls (assayed and unassayed), Class I, 21
CFR 862.1660, |
| Product Codes: | CGA, NBW; JJX |
| Predicate Device: | MEG-2 Blood Glucose Monitoring System (K101204)
MEG-2 Multi Blood Glucose Monitoring System (K101204)
MEG-2 Blood Glucose Test Strip (K101204)
MEG-2 Multi Blood Glucose Test Strip (K101204)
MEG-2 Glucose Control Solution (K101204) |
| Device Description: | The MEG-2B blood glucose meter and MEG-2B test strips are used for
testing of blood glucose by self-testers at home. The MEG-2B Pro meter
and strips are identical to the MEG-2B versions except they are sold with
labeling oriented toward the professional user, rather than the self-testing
home user. MEG-2B Glucose Control Solutions are used for quality
control testing of the system. |
| Intended Use: | MEG-2B Blood Glucose Monitoring System: The MEG-2B 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. 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. |
| | MEG-2B Pro Blood Glucose Monitoring System: The MEG-2B Pro Blood Glucose
Monitoring System is intended for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the fingertips, forearm, or palm. 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. |
| | MEG-2B Blood Glucose Test Strips: The MEG-2B Blood Glucose Test Strips are to be
used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in
capillary whole blood taken from fingertips, palm, or forearm. 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-2B Pro Blood Glucose Test Strips: The MEG-2B Pro Blood Glucose Test Strips
are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in
capillary whole blood taken from a fingertip, palm, or forearm. 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. |
| | MEG-2B Glucose Control Solutions: 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. |
| Comparison of | The MEG-2B system has been modified relative to the predicate by using a new test |
| Technological | strip holder in the meter and a corresponding modified test strip. The MEG-2B |
| Characteristics: | meter uses the same test algorithm as the predicate meter. The MEG-2B control |
| | solutions use the same component chemicals as the predicate, with slightly modified |
| | glucose levels across the three control solutions. The MEG-2B Pro meter and strips
are identical to the MEG-2B versions, except they are sold with labeling oriented |
| | toward the professional user, rather than the self-testing home user. |
| Non-Clinical | Testing was conducted as follows: EMC and Electrical Safety, drop testing, test |
| Testing: | strip holder qualification, software verification and validation (including unit |
| | integration testing), control solution qualification, and linearity testing with |
| | validation of Lo/Hi detection. Results demonstrate substantial equivalence to the |
| | predicate system. |
| Clinical Testing | Not applicable. |
| Conclusion: | Non-clinical testing demonstrated that the MEG-2B and MEG-2B Pro systems |
| | perform in a substantially equivalent manner to that of the predicate. We conclude |
| | that the two new systems are substantially equivalent to the predicate devices. |
1
510(k) Summary (Continued)
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Apex Biotechnology Corp. c.o Lisa Liu No. 7. Li-Hsin Road V. Hsinchu Science Park Hsinchu, 30078, Taiwan
APR - 6 2012
Re: K120448
Trade Name: MEG-2B Blood Glucose Monitoring System; MEG-2B Pro Blood Glucose Monitoring System; MEG-2B Glucose Control Solutions Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: March 16, 2012 Received: March 20, 2012
Dear Ms. Liu:
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.
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 Eederal 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 11 you assnow of In Vitro 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) Office of Darrollians regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may 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/ResourcesforYou/Industry/default.htm
Sincerely yours,
Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
KIZOUYO 510(k) Number (if known):
Device Name: MEG-2B Blood Glucose Monitoring System Indications for Use:
The MEG-2B 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. 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.
The MEG-2B Blood Glucose Test Strips are to be used with the MEG-2B Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. 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.
Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (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
K120448 510(k)
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5
Indications for Use Statement
510(k) Number (if known):
Device Name: MEG-2B Pro Blood Glucose Monitoring System Indications for Use:
The MEG-2B Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated to be use for multiple patients in a clinical w 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.
120440
The MEG-2B Pro Blood Glucose Test Strips are to be used with the MEG-2B Pro Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is indicated in a clinical setting to be used for multiple This system is only used with single-use, patients by healthcare professionals. auto-disabling lancing device.
Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruth Clum
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) == 12 == 4 4
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Indications for Use Statement
K 120440 510(k) Number (if known): Device Name: MEG-2B Glucose Control Solutions Indications for 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 _ Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Auto Club
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 120448
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