(30 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is described as an aid to monitor the effectiveness of diabetes control, not as a device that delivers a therapeutic intervention. It is for diagnostic use (In Vitro diagnostic use), not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is intended for the quantitative measurement of glucose in blood samples, which is a diagnostic measurement. However, it also explicitly states that "It is not indicated for the diagnosis of or screening for diabetes or for neonatal use," meaning it is for monitoring purposes rather than initial diagnosis.
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 / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This confirms that the device is intended for testing biological samples in vitro (outside of a living organism) to provide diagnostic information.
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 BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.
Product codes
NBW
Device Description
The BGM014 blood glucose meter and BGM014 test strips are used for self-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, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing 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
Non-Clinical Testing: Disinfection (viral inactivation) and “robustness” testing were done to qualify the recommended disinfection solutions. Results demonstrate substantial equivalence to the predicate.
Clinical Testing: No clinical testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
BGM014 Blood Glucose Monitoring System (K161299)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name written out as "U.S. Food & Drug Administration".
November 28, 2018
Apex Biotechnology Corp. Lisa Liu Manager of Quality Assurance Division No.7. Li-Hsin Rd. V. Hsinchu Science Park Hsinchu. 30078 Taiwan
Re: K182992
Trade/Device Name: BGM014 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 23, 2018 Received: October 29, 2018
Dear Lisa 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtnev 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: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K182992 |
| 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. 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. | |
| 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:
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"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 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
11
ਸ ਨੇ
3
| Submitter | Lisa Liu
Manager of Quality Assurance Division
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: 011-886-3-5678021 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lisa Liu
Manager of Quality Assurance Division
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: 011-886-3-5678021 |
| Date Prepared | November 21, 2018 |
| Trade Names | BGM014 Blood Glucose Monitoring System (K182992) |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | NBW |
| Predicate Devices | BGM014 Blood Glucose Monitoring System (K161299) |
| Device Description | The BGM014 blood glucose meter and BGM014 test strips are used for
self-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. |
4
510(k) Summary (Continued)
| Comparison of
Technological
Characteristics | The modified BGM014 Blood Glucose Monitoring Systems are identical to the
predicate other than the recommendation of one additional disinfectant in the
User Manuals. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical
Testing | Disinfection (viral inactivation) and “robustness” testing were done to qualify the
recommended disinfection solutions. Results demonstrate substantial
equivalence to the predicate. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified BGM014 Blood Glucose Monitoring Systems
are substantially equivalent to the predicate. |