(198 days)
Not Found
No
The description focuses on the electrochemical measurement method and standard performance testing, with no mention of AI or ML algorithms.
No
The device is an in vitro diagnostic (IVD) device used for monitoring glucose levels, which aids in managing diabetes, but does not directly provide therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not intended for neonatal use or for the diagnosis of or screening for diabetes." While it measures glucose, its purpose is for monitoring effectiveness of diabetes control, not for diagnosis.
No
The device description explicitly states that the MIO Blood Glucose Monitoring System is comprised of a "MIO Blood Glucose Meter and the MIO Blood Glucose Test Strips," which are hardware components. It also mentions the use of an "amperometric detection method" and a "4G module," further indicating hardware. While software validation is mentioned, the core functionality relies on physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This system is intended for self-testing outside the body (in vitro diagnostic use)".
Furthermore, the device measures glucose concentration in fresh capillary whole blood samples, which is a biological sample tested in vitro (outside the body) to provide information about a person's health status. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIO Blood Glucose Monitoring System is comprised of the MIO Blood Glucose Meter and the MIO Blood Glucose Test Strips. MIO Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Product codes
NBW
Device Description
MIO Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the qlucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
MIO Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips (for fresh capillary whole blood samples).
Indicated Patient Age Range
Not intended for neonatal use.
Intended User / Care Setting
Intended for use by persons with diabetes at home. Intended for self-testing outside the body.
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)
Laboratory Testing:
The performance characteristics of the MIO Blood Glucose Monitoring System were evaluated by performing the following studies:
- Within-Run Precision Evaluation
- Intermediate Precision Evaluation
- Linearity Evaluation Study
- User Evaluation
- User Evaluation - Accuracy at Extreme Glucose Values
- Interference Agents Study
- Hematocrit Effect Study
- Oxygen Interference Study
- Flex Studies- Mechanical Vibration Testing
- Flex Studies- Shock Testing
- Flex Studies- Electromagnetic compatibility (EMC) Testing
- Flex Studies- Electrostatic Discharge/Electromagnetic Interference Testing
- Accelerated Closed Vial Stability Study_Strip
- Accelerated Open Vial Stability Study_Strip
- Accelerated Closed Vial Stability Study_Control
- Accelerated Open Vial Stability Study_Control
- Sample Perturbation Study
- Real Time Closed Vial Stability Study_Strip
- Real Time Open Vial Stability Study _Strip
- Real Time Closed Vial Stability Study _Control
- Real Time Open Vial Stability Study _Control
- Operating Conditions Evaluation
- Altitude Effect Evaluation
- Error Codes Evaluation
- Short Sample Detection Study
- Intermittent Sampling Study
- Control Range Assignment
- Test Strip Lot Release Criteria
- Low Battery Study
- Shipping Study (Strip)
- Shipping Study (Control)
- Firmware (Software) Validations
- Electrical Safety Test
- Environmental Temperature Test
- Testing with Used Test Strips
- FCC Tests
- Cybersecurity Control DFMEA
- Meter Cybersecurity Management Plan
- Web App Software Validation
Discussion of Laboratory Studies:
Above laboratory studies were performed on MIO Blood Glucose Monitoring System in accordance with the applicable guidance or standards, and the test results indicated that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable.
Discussion of Clinical Study:
Clinical study (user evaluation) was conducted with intended users using the MIO Blood Glucose Monitoring System. Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the MIO Blood Glucose Monitoring System. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following the User Manual and the overall performance of the MIO Blood Glucose Monitoring System.
Conclusion:
The laboratory studies and user evaluation study results demonstrate that the MIO Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the MIO Blood Glucose Monitoring System meets FDA Guidance SMBG for OTC Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VivaChek Ino Smart Blood Glucose Monitoring System (K173140)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 28, 2023
Mio Labs Inc. Mark Qian Senior RA Engineer #1023, ZGC Innovation Center, 4500 Great America Pkwy Santa Clara, CA 95054
Re: K223722
Trade/Device Name: MIO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 30, 2023 Received: June 2, 2023
Dear Mark Qian:
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 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
1
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 mediation-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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223722
Device Name MIO Blood Glucose Monitoring System
Indications for Use (Describe)
MIO Blood Glucose Monitoring System is comprised of the MIO Blood Glucose Meter and the MIO Blood Glucose Test Strips. MIO Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | |
| Over-The-Counter Use (21 CER 801 Subpart C) | X |
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3
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
Section E: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The Assigned 510(k) number is K223722.
Submitter's Identification:
Mio Labs Inc. #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Tel: 301-910-0529
Date Updated: May 25, 2023
Contact Person:
Mark Qian Senior RA Engineer Mio Labs Inc. #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054
Proprietary Name of the Device:
MIO Blood Glucose Monitoring System
Common Name: Glucose Test System
Classification Name:
Class II §862.1345 Glucose Test System Product Code: NBW
Predicate Device:
VivaChek Ino Smart Blood Glucose Monitoring System VivaChek Laboratories, Inc. 510(k) Number: K173140
4
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
| Proprietary Name | Meter
Model | Classification | Product
Code | Description | Common
Name |
|----------------------------------------|-------------------|----------------------|-----------------|--------------------------------------------------|------------------------|
| MIO Blood Glucose
Monitoring System | TeleBGM
2282-G | 862.1345
Class II | NBW | System, Test, Blood
Glucose, Over The Counter | Glucose
Test System |
Device Name:
Description:
MIO Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the qlucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.
MIO Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.
Intended Use:
MIO Blood Glucose Monitoring System is comprised of the MIO Blood Glucose Meter and the MIO Blood Glucose Test Strips. MIO Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
5
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
Comparison to Predicate Device:
The MIO Blood Glucose Monitoring System is substantially equivalent to VivaChek Ino Smart Blood Glucose Monitoring System (K173140)
| Features | Predicate: VivaChek Ino Smart
Blood Glucose Monitoring System
(K173140) | Candidate:
Blood
Monitoring System | Glucose |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------|
| Similarities | | | |
| Intended Use | It is intended to quantitatively
measure the glucose concentration in
fresh capillary whole blood samples
drawn from the fingertips. It is
intended for use by persons with
diabetes at home as an aid to monitor
the effectiveness of diabetes control.
It is not intended for neonatal use or
for the diagnosis of or screening for
diabetes. It is intended for self-testing
outside the body (in vitro diagnostic
use), and should only be used by a
single person and should not be
shared. | Same | |
| Operation Principle | Electrochemical biosensor | Same | |
| Detection Method | Amperometric | Same | |
| Strip Chemical
Composition | Glucose oxidase | Same | |
| Measurement Result | Plasma Glucose | Same | |
| Sample | Fresh capillary whole blood | Same | |
| Memory | 500 records | Same | |
| Unit of Measure | mg/dL | Same | |
| Measurement Range | 20-600 mg/dL | Same | |
| Sample Volume | 0.8µL | Same | |
| Test Time | 5 seconds | Same | |
| Operating Relative
Humidity | 10-90% (non-condensing) | Same | |
| Operating Temperature | 41-113°F | Same | |
| Hematocrit Range | 20-70% | Same | |
| Automatic Shutoff | 2 minutes after last action | Same | |
| Power Source | Rechargeable 3.7 Volt Lithium Ion
battery | Same | |
| Differences | | | |
| Battery Type | Rechargeable, non-serviceable,
250mAh, 3.7 Volt DC nominal, lithium
polymer battery (5V input charge
voltage) | Rechargeable, 800 mAh, 3.7 Volt DC
nominal, lithium polymer battery (5V
input charge voltage) | |
6
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
| Dimensions | 83 mm x 52 mm x 18.7 mm | 95.5 mm x 59.1 mm x 20.5 mm |
|---|---|---|
| Display Size | 32mm x 32 mm | 47 mm x 37.5 mm |
| Weight | Approximately 53g | Approximately 70g |
| Data Transmission | Bluetooth | 4G |
Laboratory Testing:
The performance characteristics of the MIO Blood Glucose Monitoring System were evaluated by performing the following studies:
| No. | Test/Validation Item |
|---|---|
| 1 | Within-Run Precision Evaluation |
| 2 | Intermediate Precision Evaluation |
| 3 | Linearity Evaluation Study |
| 4 | User Evaluation |
| 5 | User Evaluation - Accuracy at Extreme Glucose Values |
| 6 | Interference Agents Study |
| 7 | Hematocrit Effect Study |
| 8 | Oxygen Interference Study |
| 9 | Flex Studies- Mechanical Vibration Testing |
| 10 | Flex Studies- Shock Testing |
| 11 | Flex Studies- Electromagnetic compatibility (EMC) Testing |
| 12 | Flex Studies- Electrostatic Discharge/Electromagnetic |
| Interference Testing | |
| 13 | Accelerated Closed Vial Stability Study_Strip |
| 14 | Accelerated Open Vial Stability Study_Strip |
| 15 | Accelerated Closed Vial Stability Study_Control |
| 16 | Accelerated Open Vial Stability Study_Control |
| 17 | Sample Perturbation Study |
| 18 | Real Time Closed Vial Stability Study_Strip |
| 19 | Real Time Open Vial Stability Study _Strip |
| 20 | Real Time Closed Vial Stability Study _Control |
| 21 | Real Time Open Vial Stability Study _Control |
| 22 | Operating Conditions Evaluation |
| 23 | Altitude Effect Evaluation |
| 24 | Error Codes Evaluation |
| 25 | Short Sample Detection Study |
| 26 | Intermittent Sampling Study |
| 27 | Control Range Assignment |
| 28 | Test Strip Lot Release Criteria |
| 29 | Low Battery Study |
| 30 | Shipping Study (Strip) |
| 31 | Shipping Study (Control) |
| 32 | Firmware (Software) Validations |
| 33 | Electrical Safety Test |
| 34 | Environmental Temperature Test |
| 35 | Testing with Used Test Strips |
| 36 | FCC Tests |
| 37 | Cybersecurity Control DFMEA |
| 38 | Meter Cybersecurity Management Plan |
| 39 | Web App Software Validation |
7
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
To confirm the 4G module has not brought any unexpected functional failure or adverse effect, DFMEA, cybersecurity control and software validation were conducted and summarized in above table.
8
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054 Contact: Mark Qian Email: Mark.qian@transtekcorp.com Tel: 301-910-0529
Discussion of Laboratory Studies:
Above laboratory studies were performed on MIO Blood Glucose Monitoring System in accordance with the applicable quidance or standards, and the test results indicated that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable.
Discussion of Clinical Study:
Clinical study (user evaluation) was conducted with intended users using the MIO Blood Glucose Monitoring System. Study results indicated that non-professional, inexperienced lay persons were able to obtain blood glucose readings when using the MIO Blood Glucose Monitoring System. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following the User Manual and the overall performance of the MIO Blood Glucose Monitoring System.
Conclusion:
The laboratory studies and user evaluation study results demonstrate that the MIO Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the MIO Blood Glucose Monitoring System meets FDA Guidance SMBG for OTC Use.
Based on the same intended use and work principle, and the same technological characteristics listed in the section Comparison to Predicate Device - Similarities, meanwhile the different technological characteristics listed in the section Comparison to Predicate Device do not raise safety and effectiveness questions according to the completed performance validation reports, therefore the candidate device MIO Blood Glucose Monitoring System is substantially equivalent to the predicate device VivaChek Ino Smart Blood Glucose Monitoring System (K173140).