(228 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is intended for the quantitative measurement of glucose to aid in monitoring the effectiveness of diabetes control, not for direct treatment or therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not indicated for the diagnosis of or screening for diabetes or for neonatal use."
No
The device description explicitly states that the system is comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strip," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)". This confirms that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.
The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in venous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.
Product codes
NBW, LFR, JJX
Device Description
The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose. The BGM014 Pro blood glucose meter and BGM014 Pro test strips are used for professional testing of blood glucose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, palm (capillary whole blood); venous whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Self-testing by people with diabetes at home (BGM014 System); multiple-patient use in professional healthcare setting (BGM014 Pro System)
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
An accuracy study was conducted with home users and professional users using finger, palm and forearm capillary whole blood. Venous blood testing was also done by the professional users. Results demonstrate substantial equivalence to the predicate system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Testing was conducted as follows: EMC and Electrical Safety, disinfection performance (robustness of meter to multiple cleanings and disinfections), software verification and validation, linearity testing with validation of Lo/Hi detection, temperature and humidity testing, sample volume verification, precision testing, interferences testing, altitude testing, qualification of control solutions, hematocrit performance testing, Results demonstrate substantial equivalence to the predicate system.
Clinical Testing: An accuracy study was conducted with home users and professional users using finger, palm and forearm capillary whole blood. Venous blood testing was also done by the professional users. Results demonstrate substantial equivalence to the predicate system.
Conclusion: Clinical and non-clinical testing demonstrated that the BGM014 and BGM014 Pro systems perform in a substantially equivalent manner to that of the predicate. We conclude that the BGM014 and BGM014 Pro systems are substantially equivalent to the predicate system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AutoSure HT Blood Glucose Monitoring System (K131750)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
December 23, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN
Re: K161299
Trade/Device Name: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: November 30, 2016 Received: December 5, 2016
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,
Kellie B. Kelm -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
2
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) K161299
Device Name BGM014 Blood Glucose Monitoring System
Indications for Use (Describe)
The BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto diagnostic use), It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.
The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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
510(k) Number (if known) K161299
Device Name
BGM014 Pro Blood Glucose Monitoring System
Indications for Use (Describe)
The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.
The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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
9 510(k) Summary
| Submitter: | Apex Biotechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Dec 19, 2016 |
| Trade Names: | BGM014 Blood Glucose Monitoring System
BGM014 Pro Blood Glucose Monitoring System |
| 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: | NBW, LFR, JJX |
| Predicate Devices: | AutoSure HT Blood Glucose Monitoring System (K131750) |
| Device Description: | The BGM014 blood glucose meter and BGM014 test strips are used for
self-testing of blood glucose. The BGM014 Pro blood glucose meter and
BGM014 Pro test strips are used for professional testing of blood
glucose. |
| Intended Use: | BGM014 System: The BGM014 Blood Glucose Monitoring System is
intended for the quantitative measurement of glucose in fresh capillary whole
blood samples drawn from the fingertips, forearm, or palm. Alternative site
testing should be performed only during steady-state (when glucose is not
changing rapidly). Testing is done outside the body (In Vitro diagnostic
use). It is intended for self-testing by people with diabetes at home as an aid
to monitor the effectiveness of diabetes control. It should only be used by a
single patient and it should not be shared. It is not indicated for the diagnosis
of or screening for diabetes or for neonatal use. |
| | The BGM014 Blood Glucose Monitoring System is comprised of the
BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip. |
| | The Contrex Plus 5 glucose control solution is used with the BGM014 Meter
and BGM014 Test Strip, to verify that the meter and test strip are working
together properly and that the test is performing correctly. |
| Intended Use: | BGM014 Pro System: The BGM014 Pro Blood Glucose Monitoring System
is intended for quantitatively measurement of glucose in venous whole
blood, or capillary whole blood drawn from fingertips, palm, or forearm.
Alternative site testing should be performed only during steady-state (when
glucose is not changing rapidly). Testing is done outside the body (In Vitro
diagnostic use). It is intended for multiple-patient use in professional
healthcare settings as an aid to monitor effectiveness of diabetes control
program. This system should only be used with single use, auto-disabling
lancing devices. It is not indicated for the diagnosis of or screening for
diabetes or for neonatal use. |
| | The BGM014 Pro Blood Glucose Monitoring System is comprised of the
BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test
Strip. |
| | The Contrex Plus 5 glucose control solution is used with the BGM014 Pro
Meter and BGM014 Pro Test Strip, to verify that the meter and test strip are
working together properly and that the test is performing correctly. |
5
510(k) Summary (Continued)
6
510(k) Summary (Continued)
| Non-Clinical
Testing: | Testing was conducted as follows: EMC and Electrical Safety, disinfection
performance (robustness of meter to multiple cleanings and disinfections),
software verification and validation, linearity testing with validation of Lo/Hi
detection, temperature and humidity testing, sample volume verification,
precision testing, interferences testing, altitude testing, qualification of
control solutions, hematocrit performance testing, Results demonstrate
substantial equivalence to the predicate system. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing | An accuracy study was conducted with home users and professional users
using finger, palm and forearm capillary whole blood. Venous blood testing
was also done by the professional users. Results demonstrate substantial
equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the BGM014 and
BGM014 Pro systems perform in a substantially equivalent manner to that of
the predicate. We conclude that the BGM014 and BGM014 Pro systems are
substantially equivalent to the predicate system. |