(41 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is used for monitoring blood glucose levels, aiding in the control of diabetes by providing quantitative measurements. It does not directly treat or cure the condition, but rather provides information for managing it.
Yes
The device is described as an "in vitro diagnostic use" for "quantitative measurement of glucose." While it explicitly states "It is not indicated for the diagnosis or screening of diabetes," it aids in "monitoring the effectiveness of diabetes control," which is a diagnostic purpose to track the state of a disease.
No
The device description explicitly states that the system consists of a "BGM009 Plus meter and BGM009 Test Strips," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device fits this description as it measures glucose in blood samples.
- Purpose: The purpose is to measure glucose in blood samples to aid in monitoring diabetes control, which is a diagnostic purpose performed outside the body.
N/A
Intended Use / Indications for Use
The BGM009 Plus 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The BGM009 Plus blood glucose monitoring system consists of the BGM009 Plus meter and BGM009 Test Strips. It is used for testing of blood glucose by self-testers at home.
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
self testing outside the body (in vitro diagnostic use) by people with diabetes at home
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: Software verification and validation were done.
Clinical Testing: N/A
Conclusion: Non-clinical testing show that the BGM009 Plus meter with the BGM009 Strips perform in a substantially equivalent manner to that of the predicate device. We conclude that the BGM009 Plus system is 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.
BGM009 (K141036) Blood Glucose Monitoring Systems
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
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 image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
APEX BIO TECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK HSINCHU 30078 TAIWAN
Re: K170267
Trade/Device Name: BGM009 Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: February 6, 2017 Received: February 8, 2017
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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K170267 |
|---|---|
| Device Name | BGM009 Plus Blood Glucose Monitoring System |
| Indications for Use (Describe) | The BGM009 Plus 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). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. |
| The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. | |
| 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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
510(k) Summary 6
| 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 | January 25, 2017 |
| Trade Names | BGM009 Plus Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | BGM009 (K141036) Blood Glucose Monitoring Systems |
| Device Description | The BGM009 Plus blood glucose monitoring system consists of the BGM009
Plus meter and BGM009 Test Strips. It is used for testing of blood glucose by
self-testers at home. |
4
510(k) Summary (Continued)
| Intended Use | The BGM009 Plus 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). It is intended for self testing
outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in
monitoring the effectiveness of diabetes control and should only be used by a single
patient and it should not be shared. It is not indicated for the diagnosis or screening of
diabetes or for neonatal use.
The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and
BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary
whole blood taken from fingertips, palm, or forearm. |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The BGM009 Plus meter uses the same test strip and test algorithm as the predicate.
The only difference is that the voice feature has been removed from the meter. |
| Non-Clinical
Testing | Software verification and validation were done. |
| Clinical Testing | N/A |
| Conclusion | Non-clinical testing show that the BGM009 Plus meter with the BGM009 Strips
perform in a substantially equivalent manner to that of the predicate device. We
conclude that the BGM009 Plus system is substantially equivalent to the predicate. |