(582 days)
No
The summary describes a standard blood glucose and ketone monitoring system based on test strips and a meter, with no mention of AI or ML in the device description, intended use, or performance studies.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an in vitro diagnostic device used solely for monitoring blood glucose and ketone levels to aid in diabetes control, not for treatment.
Yes
The device is described as an "in vitro diagnostic use" system that measures blood glucose and ketone levels to aid in monitoring diabetes control. While it explicitly states "It is not intended for diagnosis or screening of diabetes," its function for monitoring a disease state classifies it as a diagnostic device in the broader sense of providing information for health assessment.
No
The device description explicitly states it consists of a meter, test strips, and control solutions, which are all hardware components. While software verification and validation are mentioned, the device is clearly a system with physical parts.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The system is intended for self-testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The system measures blood glucose and blood ketone levels in a sample of blood taken from the body. This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample outside of the living organism to provide information about the patient's health status.
- Purpose: The intended use is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
Therefore, based on the provided information, the MTM301 Blood Glucose and Ketone Monitoring System is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips.
The MTM301 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 (comma separated list FDA assigned to the subject device)
NBW, JIN
Device Description
The MTM301 Blood Glucose and Ketone Monitoring System consists of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution (Level 1, Level 2), and MTM301 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution, and MTM301 ketone control solution are purchased separately.
The glucose test strips utilized in the MTM301 Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips previously cleared in K170267 ; The ketone test strips are the same as the KET-1 Blood Ketone test strips, previously cleared in K182593.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not Found
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: disinfection performance (robustness of meter to multiple cleanings and disinfections), software verification and validation, linearity study, precision testing, repeatability testing, temperature and humidity testing, intermittent sampling testing, sample perturbation testing and stability test. 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.
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.
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.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
April 6, 2022
Apex Biotechnology Corp. Lisa Liu Manager of Quality Assurance Division No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, 30078 Taiwan
Re: K202534
Trade/Device Name: MTM301 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: December 30, 2021 Received: January 6, 2022
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
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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K202534
Device Name
MTM301 Blood Glucose and Ketone Monitoring System
Indications for Use (Describe)
MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips.
The MTM301 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| 510(k) number | K202534 |
|---|---|
| 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: | MTM301 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 MTM301 Blood Glucose and Ketone Monitoring System consists |
| of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood | |
| Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose | |
| Control Solution (Level 1, Level 2), and MTM301 ketone control solution | |
| (Level 1 and Level 2). The system is for self-testing of blood glucose and | |
| blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood | |
| Ketone test strips, MTM301 Glucose Control Solution, and MTM301 | |
| ketone control solution are purchased separately. | |
| The glucose test strips utilized in the MTM301 Blood Glucose and Ketone | |
| Monitoring System are the same as the BGM009 glucose test strips | |
| previously cleared in K170267 ; The ketone test strips are the same as | |
| the KET-1 Blood Ketone test strips, previously cleared in K182593. | |
| Intended Use: | MTM301 Blood Glucose and Ketone Monitoring System: MTM301 |
| Blood Glucose and Ketone Monitoring System is comprised of the | |
| MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose | |
| Test Strips, and the MTM301 Blood Ketone test strips. | |
| The MTM301 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 MTM301 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 MTM301 Blood Glucose and Ketone meter measures the | |
| current and shows the test result in 5 seconds. The technological | |
| characteristics of MTM301 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 β -hydroxybutyrate dehydrogenase (HBDH). The
MTM301 Blood Ketone test strips contains the enzyme, HBDH, when
blood flow into the reaction zone, the enzyme reacts with β-
Hydroxybutyrate (β-ketone) in blood and produces electrical current. The
MTM301 Blood Glucose and Ketone meter measures the current and
shows the test result in 8 seconds. The technological characteristics of
MTM301 Blood Glucose and Ketone Monitoring System are substantially
equivalent to the predicate system (K091547). |
| Non-Clinical
Testing: | Testing was conducted as follows: disinfection performance (robustness
of meter to multiple cleanings and disinfections), software verification
and validation, linearity study, precision testing, repeatability testing,
temperature and humidity testing, intermittent sampling testing, sample
perturbation testing and stability test. 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 MTM301 Blood
Glucose and Ketone Monitoring System perform in a substantially equivalent
manner to that of the predicate. We conclude that the MTM301 Blood
Glucose and Ketone Monitoring System is substantially equivalent to the
predicate system. |
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