(465 days)
No
The summary describes a standard blood glucose and ketone monitoring system with data transmission capabilities. There is no mention of AI, ML, or any algorithms that would suggest their use in data analysis or interpretation beyond basic measurement and storage.
No.
This device is an in vitro diagnostic device used for monitoring blood glucose and ketone levels, which aids in managing diabetes but does not directly treat the condition.
No
The "Intended Use" section explicitly states, "It is not intended for diagnosis or screening of diabetes or for neonatal use."
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, in addition to the data transmission capabilities. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home..."
This statement clearly identifies the device as being used for diagnostic purposes outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.
The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus 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 intended for diagnosis or screening of diabetes or for neonatal use.
Product codes
NBW, JIN
Device Description
The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately.
MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured.
The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in K170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in K182593.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips (fresh capillary whole blood)
Indicated Patient Age Range
Not intended for neonatal use.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus 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: Testing was conducted as follows: EMC and Electrical Safety, disinfection performance (robustness of meter to multiple cleanings and disinfections), software verification and validation including cybersecurity management, precision testing, repeatability testing, temperature and humidity testing, intermittent sampling testing, sample perturbation testing, stability and results demonstrate substantial equivalence to the predicate system.
Clinical Testing: Accuracy studies for glucose and ketone were conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system.
Conclusion: Clinical and analytical testing demonstrated that the MultiSure GK Link Blood Glucose and Ketone Monitoring System perform in a substantially equivalent manner to that of the predicate. We conclude that the MultiSure GK Link Blood Glucose and Ketone Monitoring System is substantially equivalent to the predicate system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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October 15, 2021
Apex Biotechnology Corp. Lisa Liu Manager of Quality Assurance Division No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 Taiwan
Re: K201880
Trade/Device Name: MultiSure GK Link Blood Glucose and Ketone Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW. JIN Dated: February 9, 2021 Received: February 12, 2021
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres. Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201880
Device Name
MultiSure GK Link Blood Glucose and Ketone Monitoring System
Indications for Use (Describe)
MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.
The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus 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 intended for 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)
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510(k) Summary
| 510(k) number | K201880 |
|---|---|
| Submitter: | Apex Biotechnology Corp. |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) | |
| 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 | |
| Trade Names: | MultiSure GK Link Blood Glucose and Ketone Monitoring System |
| Classification: | Blood glucose test system, over the counter, 21 CFR 862.1345, Class II |
| Ketones (nonquantitative) test system, 21 CFR 862.1435, Class I, meets | |
| the limitation of exemption 21 CFR 862.9(c)(5). | |
| Product Codes: | NBW • JIN |
| Predicate Devices: | Nova Max Plus Blood Glucose and β-Ketone Monitoring System |
| (K091547) | |
| Device Description: | The MultiSure GK Link Blood Glucose and Ketone Monitoring System |
| consists of the MultiSure GK Link Blood Glucose and Ketone Meter, | |
| MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test | |
| strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and | |
| Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The | |
| system is for self-testing of blood glucose and blood ketone. The MultiSure | |
| GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, | |
| Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control | |
| solution are purchased separately. | |
| MultiSure GK Link Blood Glucose and Ketone Monitoring System | |
| enables automatic transmission of stored data to a data management | |
| system using upload data via USB cable (optional), or mobile device with | |
| Bluetooth when the meter and data management systems are properly | |
| configured. | |
| The glucose test strips and glucose control solution utilized in the MultiSure | |
| GK Link Blood Glucose and Ketone Monitoring System are the same as | |
| the BGM009 glucose test strips and Contrex Plus 4 Glucose Control | |
| Solution, previously cleared in K170267; The ketone test strips and ketone | |
| control solution are the same as the KET-1 Blood Ketone test strips and | |
| KET-1 ketone control solution, previously cleared in K182593. | |
| Intended Use: | MultiSure GK Link Blood Glucose and Ketone Monitoring System: |
| MultiSure GK Link Blood Glucose and Ketone Monitoring System is | |
| comprised of the MultiSure GK Blood Glucose and Ketone Meter, the | |
| MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood | |
| Ketone test strips. | |
| The MultiSure GK Link Blood Glucose and Ketone Monitoring System is | |
| intended to quantitatively measure blood glucose or blood ketone in fresh | |
| capillary whole blood drawn from fingertips. The system is intended for | |
| self-testing outside the body (in vitro diagnostic use) by people with | |
| diabetes mellitus 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 intended for diagnosis or screening of diabetes or | |
| for neonatal use. | |
| Comparison of | |
| Technological | |
| Characteristics: | Glucose measurement is based on electrochemical biosensor technology |
| using the enzyme Glucose Oxidase (GOD) The MultiSure GK Blood | |
| Glucose test strips contains the enzyme, GOD, when blood flow into the | |
| reaction zone, the enzyme reacts with glucose in blood and produces | |
| electrical current. The MultiSure GK Link Blood Glucose and Ketone | |
| meter measures the current and shows the test result in 5 seconds. The | |
| technological characteristics of MultiSure GK Link Blood Glucose and | |
| Ketone Monitoring System are substantially equivalent to the predicate | |
| system (K091547). | |
| Ketone measurement is based on electrochemical biosensor technology | |
| using the enzyme $\beta$ -hydroxybutyrate dehydrogenase (HBDH). The | |
| MultiSure GK Blood Ketone test strips contains the enzyme, HBDH, when | |
| blood flow into the reaction zone, the enzyme reacts with $\beta$ - Hydroxybutyrate ( $\beta$ -ketone) in blood and produces electrical current. The | |
| MultiSure GK Link Blood Glucose and Ketone meter measures the current | |
| and shows the test result in 8 seconds. The technological characteristics of | |
| MultiSure GK Link Blood Glucose and Ketone Monitoring System are | |
| substantially equivalent to the predicate system (K091547). | |
| 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 including cybersecurity management, | |
| precision testing, repeatability testing, temperature and humidity testing, | |
| intermittent sampling testing, sample perturbation testing, stability and | |
| results demonstrate substantial equivalence to the predicate system. | |
| Clinical Testing | Accuracy studies for glucose and ketone were conducted with home users, |
| including evaluation of ease of use and ease of understanding of the user | |
| manual. Results demonstrate substantial equivalence to the predicate | |
| system. | |
| Conclusion: | Clinical and analytical testing demonstrated that the MultiSure GK Link |
| Blood Glucose and Ketone Monitoring System perform in a substantially | |
| equivalent manner to that of the predicate. We conclude that the MultiSure | |
| GK Link Blood Glucose and Ketone Monitoring System is substantially | |
| equivalent to the predicate system. |
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