(198 days)
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.
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.
The MIO Blood Glucose Monitoring System is a glucose test system designed for quantitative measurement of glucose concentration in fresh capillary whole blood samples. The acceptance criteria and performance of the device are derived from the information provided in the Sections E: 510(k) Summary and Indications for Use.
It's important to note that the provided text primarily focuses on the device's substantial equivalence to a predicate device and lists various laboratory and clinical studies conducted. However, it does not explicitly detail the specific acceptance criteria values or the reported performance outcomes for most of these studies. It broadly states that "the test results indicated that the acceptance criteria were met" and "the performances from these laboratory studies were acceptable." The only quantitative performance data provided is related to the comparison with the predicate device (e.g., measurement range, sample volume, test time).
Given the limitations of the provided text, I will construct the table and responses based on the available information regarding the device's characteristics and the general statements about meeting acceptance criteria. For elements not explicitly quantified, I will indicate that the information is "Not explicitly stated/quantified in the provided document."
Acceptance Criteria and Device Performance
The provided document indicates that the MIO Blood Glucose Monitoring System underwent various laboratory and user evaluation studies, and the results met the acceptance criteria. While specific numerical acceptance criteria and corresponding performance values for all tests are not detailed, the document emphasizes substantial equivalence to a predicate device, which implies adherence to recognized standards for glucose monitoring systems.
Table of Acceptance Criteria and Reported Device Performance
| Criterion Category (Study Type) | Acceptance Criteria (Based on general good practice for BGMS)* | Reported Device Performance (as stated or implied) |
|---|---|---|
| Accuracy (Overall System) | Meets ISO 15197:2013 standards for BGMs (e.g., specific percentages of measurements within ±15 mg/dL or ±15% of reference for different glucose ranges). | Adequately demonstrated through User Evaluation and User Evaluation - Accuracy at Extreme Glucose Values. "the test results indicated that the acceptance criteria were met." |
| Precision (Within-Run) | Low coefficient of variation (CV) or standard deviation (SD) for replicate measurements within a single run. | "the test results indicated that the acceptance criteria were met." |
| Precision (Intermediate) | Low CV or SD across multiple runs, days, or operators. | "the test results indicated that the acceptance criteria were met." |
| Linearity | Expected correlation between measured and reference glucose values across the measurement range. | "the test results indicated that the acceptance criteria were met." |
| Interference | No significant impact on glucose readings from common interfering substances. | "the test results indicated that the acceptance criteria were met." |
| Hematocrit Effect | Accurate readings across the specified hematocrit range. | "the test results indicated that the acceptance criteria were met." |
| Oxygen Interference | Accurate readings under various oxygen partial pressures. | "the test results indicated that the acceptance criteria were met." |
| Adverse Environmental (Flex Studies) | Device functions within specifications after exposure to vibration, shock, EMC, ESD. | "the test results indicated that the acceptance criteria were met." |
| Stability (Strip & Control, Closed/Open Vial) | Long-term stability of test strips and control solutions under specified storage conditions. | "the test results indicated that the acceptance criteria were met." |
| Operating Conditions (Temp, Humidity, Altitude) | Device functions within specifications across defined environmental limits. | "the test results indicated that the acceptance criteria were met." |
| User Evaluation (Usability) | Lay persons can use the system effectively and safely, obtaining accurate readings with satisfaction. | Study results indicated that "non-professional, inexperienced lay persons were able to obtain blood glucose readings" and "were questioned and responded as satisfied with the ease of operation by following the User Manual and the overall performance." |
| Error Codes Evaluation | System reliably identifies and displays appropriate error codes for malfunctions. | "the test results indicated that the acceptance criteria were met." |
| Short Sample Detection | System reliably detects insufficient sample volume. | "the test results indicated that the acceptance criteria were met." |
| Intermittent Sampling | System performs as expected if blood sample collection is interrupted and resumed. | "the test results indicated that the acceptance criteria were met." |
| Low Battery Performance | System functions correctly or provides appropriate warnings with low battery. | "the test results indicated that the acceptance criteria were met." |
| Software/Firmware Validation | Software and firmware perform as intended without defects impacting safety or efficacy. | "the test results indicated that the acceptance criteria were met." Concurrently, DFMEA and cybersecurity controls conducted. |
| Electrical Safety | Meets relevant safety standards. | "the test results indicated that the acceptance criteria were met." |
| Cybersecurity | Controls in place to protect device integrity and patient data. | Cybersecurity Control DFMEA and Meter Cybersecurity Management Plan conducted; results accepted. |
*Note: Specific numerical acceptance criteria were not provided in the document. The descriptions reflect general expectations for such devices based on regulatory guidance (e.g., FDA guidance for SMBG for OTC Use, and ISO 15197:2013 for glucose monitoring systems, which the report states the device meets).
Study Details:
-
A table of acceptance criteria and the reported device performance
See the table above. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document lists "User Evaluation" and "User Evaluation - Accuracy at Extreme Glucose Values" as key studies, implying test sets of human subjects. However, the exact sample sizes for these studies are not explicitly stated in the provided text. For laboratory studies (e.g., precision, linearity, interference), the sample sizes (e.g., number of replicates, number of interfering substances) are also not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective as they are described as "performed" or "conducted" to evaluate the device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document describes a "User Evaluation" where "non-professional, inexperienced lay persons" were able to obtain blood glucose readings. The ground truth for blood glucose monitoring systems is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel. The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth, but it implies standard laboratory practices were followed as "laboratory studies were performed... in accordance with the applicable guidance or standards." No specific "expert" human readers are mentioned in the context of interpreting results or establishing ground truth beyond the users themselves taking their readings. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of "adjudication" (e.g., multiple readers resolving discrepancies) is typically relevant for interpretative diagnostic devices (e.g., radiology AI). For a blood glucose monitoring system, the ground truth is established by a quantitative laboratory reference method, not by expert interpretation requiring adjudication. Therefore, an adjudication method in this sense is not applicable and was not performed. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The MIO Blood Glucose Monitoring System is a standalone measurement device for self-testing (OTC Use). There is no AI component mentioned in the device's description that assists human readers in interpreting results. Therefore, an MRMC comparative effectiveness study was not done, and effect sizes related to human improvement with AI assistance are not applicable. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The MIO Blood Glucose Monitoring System is a device that provides a direct quantitative measurement of blood glucose. Its core function is an "algorithm only" in the sense that the device's internal processing yields the glucose concentration. The "User Evaluation" study assesses the device's performance when used by lay persons, which inherently involves human interaction with the device (applying blood, reading results). However, the accuracy metrics themselves (e.g., precision, linearity, interference) tested in "Laboratory Testing" are inherent to the device's standalone performance, independent of human interpretive input. So, yes, its standalone performance was evaluated extensively across multiple laboratory studies (e.g., linearity, precision, interference, environmental stability). -
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for a Blood Glucose Monitoring System is established by comparison to a highly accurate laboratory reference method. This is standard practice for evaluating glucose meters. The document does not explicitly name the reference method used (e.g., YSI glucose analyzer), but it's implied by the nature of the studies (e.g., "Accuracy at Extreme Glucose Values" would require a precise reference). -
The sample size for the training set
The document describes the device as a glucose monitoring system, not an AI/ML device that requires a "training set" in the context of machine learning model development. The system's operation is based on an electrochemical biosensor and fixed algorithms for calculating glucose concentration from electrical current. Therefore, a "training set" in the common AI/ML sense is not applicable for this type of device. -
How the ground truth for the training set was established
As there is no "training set" in the AI/ML context for this device, the question of how its ground truth was established is not applicable. The ground truth for calibrating the device during manufacturing and for validating its performance is based on highly accurate laboratory reference methods as described in point 7.
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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
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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
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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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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
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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 | MeterModel | Classification | ProductCode | Description | CommonName |
|---|---|---|---|---|---|
| MIO Blood GlucoseMonitoring System | TeleBGM2282-G | 862.1345Class II | NBW | System, Test, BloodGlucose, Over The Counter | GlucoseTest 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.
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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 SmartBlood Glucose Monitoring System(K173140) | Candidate:BloodMonitoring System | Glucose |
|---|---|---|---|
| Similarities | |||
| Intended Use | It is intended to quantitativelymeasure the glucose concentration infresh capillary whole blood samplesdrawn from the fingertips. It isintended for use by persons withdiabetes at home as an aid to monitorthe effectiveness of diabetes control.It is not intended for neonatal use orfor the diagnosis of or screening fordiabetes. It is intended for self-testingoutside the body (in vitro diagnosticuse), and should only be used by asingle person and should not beshared. | Same | |
| Operation Principle | Electrochemical biosensor | Same | |
| Detection Method | Amperometric | Same | |
| Strip ChemicalComposition | 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 RelativeHumidity | 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 Ionbattery | Same | |
| Differences | |||
| Battery Type | Rechargeable, non-serviceable,250mAh, 3.7 Volt DC nominal, lithiumpolymer battery (5V input chargevoltage) | Rechargeable, 800 mAh, 3.7 Volt DCnominal, lithium polymer battery (5Vinput charge voltage) |
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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/ElectromagneticInterference 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 |
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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.
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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).
§ 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.