(228 days)
VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).
The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) 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.
VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.
The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.
VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability.
Here's a breakdown of the acceptance criteria and study information for the VivaChek™ Blood Glucose and ß-Ketone Monitoring System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list acceptance criteria values for most studies, but rather states that the studies "Pass" or "were acceptable." For the performance characteristics, it focuses on demonstrating equivalence to the predicate device. For the clinical study, the acceptance criteria were based on participants' ability to obtain readings and satisfaction with ease of operation and overall performance.
For the B-Ketone performance studies, generally, the acceptance criteria for a blood ketone monitoring system would align with ISO 15197 or similar guidelines, requiring a certain percentage of results to fall within defined accuracy ranges when compared to a reference method (e.g., laboratory analyzer). While not explicitly stated with numerical targets, the "Pass" conclusion for studies like Linearity, Precision, and Interfering Agents implies adherence to such generally accepted analytical performance standards.
| Study Type | Acceptance Criteria (Implied/General) | Reported Device Performance (as per document) |
|---|---|---|
| B-Ketone Analytical Performance | ||
| Linearity Study | Demonstrate consistent and accurate measurements across the entire measuring range (0.1 - 8.0 mmol/L) | Pass |
| Within-Run Precision Study | Low variability in results when testing the same sample multiple times within a single run | Pass |
| Intermediate Precision Study | Low variability in results over time, different operators, and different test strips/reagents | Pass |
| Hematocrit Effect Study | Accurate measurements across the specified hematocrit range (20-65%) | Pass |
| Sample Volume Study | Accurate measurements with the specified sample volume (0.8 µL) | Pass |
| Altitude Effect Evaluation | Accurate measurements across relevant altitude variations | Pass |
| Operating Conditions Evaluation | Accurate measurements within specified operating temperature (45.5-113°F) and RH (10-90%) | Pass |
| Interference Agents Study | Accurate measurements in the presence of common interfering substances | Pass |
| Stability Studies | ||
| Accelerated Closed Vial Test Strip Stability Study | Maintain performance specifications under accelerated aging conditions | Pass |
| Accelerated Closed Control Stability Study | Maintain performance specifications under accelerated aging conditions | Pass |
| Accelerated Open Vial Test Strip Stability Study | Maintain performance specifications under accelerated aging conditions | Pass |
| Real Time Open Vial Test Strip Stability Study | Maintain performance specifications over the stated shelf-life under real-time conditions | Pass |
| System and Usability | ||
| User Evaluation | Non-professional, inexperienced lay persons able to obtain ß-ketone readings; satisfactory ease of operation and overall performance. | Study results indicated that non-professional, inexperienced lay persons were able to obtain ß-ketone readings. Participants were satisfied with ease of operation and overall performance. |
| Error Codes Test | Proper functioning and accurate display of error codes | Pass |
| Meter Environmental Temperature Test | Meter functions correctly and accurately within specified environmental temperatures | Pass |
| Meter Robustness Study | Meter withstands specified physical stresses without performance degradation | Pass |
| Shipping Study (Ketone Strip & Control) | Maintain performance specifications after shipping simulation | Pass |
| Meter Software Documentation | Software meets specified requirements and documentation is complete | Pass |
| Testing with Used Test Strips | Prevention of reuse of test strips or proper error indication | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the individual non-clinical (laboratory) studies. For the User Evaluation (clinical study), it refers to "participated lay persons" without specifying the exact number.
The provenance of the data is not mentioned in terms of country of origin. The studies are described as "non-clinical (laboratory) studies" and a "clinical (user evaluation) study," indicating they are likely prospective experiments conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For analytical devices like this, ground truth for accuracy studies (e.g., Linearity, Precision) would typically be established by a reference laboratory method using highly accurate and calibrated instruments, not necessarily by experts in the sense of human interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given the nature of a quantitative measurement device, the comparison would typically be against a reference method, rather than requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation of images or other subjective data, which is not the case for a blood ketone and glucose monitoring system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the analytical and performance studies listed (e.g., Linearity, Precision, Hematocrit Effect, Interference) represent standalone (algorithm only) performance of the device without human-in-the-loop interpretation beyond operating the device. The device provides a quantitative numerical output directly. The "User Evaluation" did involve humans, but primarily to assess their ability to use the device and obtain a reading, not to interpret the reading itself.
7. The Type of Ground Truth Used
For the analytical performance studies (e.g., Linearity, Precision, Hematocrit, Interference), the ground truth would typically be established by a reference laboratory method or highly accurate comparative instrument. The document refers to "corresponding study protocols," which would detail these reference methods, but the specific methods are not described in this summary.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is not described as using machine learning or AI that would require a distinct training set in the conventional sense. Its performance is based on established electrochemical principles.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or implied for an AI/ML context, this information is not applicable.
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June 5, 2020
Vivachek Biotech (Hangzhou) Co., Ltd Mark Qian Quality Director 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou, 311100 China
Re: K192957
Trade/Device Name: VivaChek™ Blood Glucose and B-Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR 862.9(c)(5) Product Code: JIN Dated: May 11, 2020 Received: May 14, 2020
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 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. Acting 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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Indications for Use
510(k) Number (if known) K192957
Device Name
VivaChek™ Blood Glucose and ß-Ketone Monitoring System
Indications for Use (Describe)
VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and ß-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).
The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) 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 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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Revision: 4
Section G. 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 K192957
Submitter's Identification:
VivaChek Biotech (Hangzhou) Co., Ltd
1/2/3 F, Building 1, 16 East Zhenxing Rd., and Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang, China
Tel: +86-571-8918-9521
Date Updated: Jun 05, 2020
Contact Person:
Mark Qian Quality Director
VivaChek Biotech (Hangzhou) Co., Ltd
1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Economy Development Zone, Yuhang, Hangzhou, 311100, Zhejiang, China
Proprietary Name:
VivaChek™ Blood Glucose and β-Ketone Monitoring System
Common Name:
Blood Glucose and ß-Ketone Test System
Classification Name:
Class II 21 CFR §862.1345 Glucose Test System Product code: NBW
Class I, 21 CFR §862.1435 Ketones (nonquantitative) test system, meets limitations of exemptions 21 CFR 862.9(c)(5).
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Revision: 4
Product code: JIN
Predicate Device Name:
KetoSens Blood β-Ketone Monitoring System
Predicate K Number:
Description:
VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.
The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.
VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability. Refer to the relative FCC Test Reports in this submission.
Intended Use:
VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood ß-Ketone Test Strips (VKS01).
The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or ß-ketone (beta-hydroxybutyrate) 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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Revision: 4
Technological Characteristics:
Specification of VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200):
| Feature | Specification |
|---|---|
| Measurement Range | Blood glucose: 20 - 600mg/dL;Blood β-ketone: 0.1 - 8.0 mmol/L |
| Test Measured | Blood Glucose and/or β-Ketone in fingertip capillary wholeblood |
| Operating Principle | Amperometric |
| Sample | Fresh capillary whole blood |
| Sample Volume | Blood glucose: 0.8 µL;Blood β-ketone: 0.8 µL |
| Test Time | Blood glucose: 5 seconds;Blood β-ketone: 10 seconds |
| Power Source | Two AAA LR03 1.5V batteries |
| Units of Measure | Blood glucose: Milligrams per deciliter (mg/dL) ;Blood β-ketone: Millimoles per liter (mmol/L) |
| Memory | Up to 1000 records |
| Automatic Shutoff | 2 minutes after last action |
| Operating Temperature | 45.5-113°F |
| Operating RH | 10-90% |
| Hematocrit Range | 20-65% |
| Battery Life | 12 months or approximately 1,000 tests |
| Bluetooth | Bluetooth Low Energy (BLE) |
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Revision: 4
Comparison to Predicate Device on Technological Characteristics:
VivaChek Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is substantially equivalent to:
| Predicate Device | Candidate Device | |
|---|---|---|
| Features | KetoSens Blood β-KetoneMonitoring System(K170463) | VivaChek™ Blood Glucose andβ-Ketone Monitoring System(Model: VGM200) |
| Similarities | ||
| Intended Use | For the quantitative measurement ofβ-Ketone in fresh capillary whole blood asan aid to monitor the effectiveness ofdiabetes control program. The system isnot intended for use in the diagnosis of orscreening for diabetes mellitus and is notintended for use on neonates. Thissystem is intended to be used by a singleperson and should not be shared. | Same |
| Use Type | Single patient use | Same |
| Specimen | Capillary whole blood from the fingertips | Same |
| Measurement Method | Amperometric | Same |
| Measurement Range | 0.1 - 8.0 mmol/L | Same |
| Strip Active Reagent | β-hydroxybutyrate dehydrogenase | Same |
| Operating Relative Humidity | 10-90% | Same |
| Test Strip Calibration Coding | Auto-coding | Same |
| Differences | ||
| Operating Temperature | 50-100°F | 45.5-113°F |
| Sample Volume | 0.5 µL | 0.8 µL |
| Hematocrit Range | 20-55% | 20-65% |
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Revision: 4
Laboratory Testing:
The performance characteristics of the VivaChek™ Blood Glucose and β-Ketone Monitoring System were evaluated by performing the following non-clinical studies:
| No. | Study | Conclusion |
|---|---|---|
| 1 | Linearity Study | Pass |
| 2 | User Evaluation | Pass |
| 3 | Accelerated Closed Vial Test Strip Stability Study | Pass |
| 4 | Accelerated Closed Control Stability Study | Pass |
| 5 | Accelerated Open Vial Test Strip Stability Study | Pass |
| 6 | Real Time Open Vial Test Strip Stability Study | Pass |
| 7 | Hematocrit Effect Study | Pass |
| 8 | Sample Volume Study | Pass |
| 9 | Intermediate Precision Study | Pass |
| 10 | Within-Run Precision Study | Pass |
| 11 | Altitude Effect Evaluation | Pass |
| 12 | Operating Conditions Evaluation | Pass |
| 13 | Shipping Study for Ketone Test Strip | Pass |
| 14 | Shipping Study for Ketone Control | Pass |
| 15 | Interference Agents Study | Pass |
| 16 | Error Codes Test | Pass |
| 17 | Meter Environmental Temperature Test | Pass |
| 18 | Testing with Used Test Strips | Pass |
| 19 | Meter Software Documentation | Pass |
| 20 | Meter Robustness Study | Pass |
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Revision: 4
Brief Discussion of Non-Clinical Studies:
Above non-clinical (laboratory) studies were performed on the VivaChek™ Blood Glucose and ß-Ketone Monitoring System in accordance with the corresponding study protocols, and the test results indicated that the acceptance criteria were met. Therefore the ketone performances from these non-clinical (laboratory) studies were acceptable.
Brief Discussion of Clinical Study:
User evaluation study was conducted in accordance with the User Evaluation Study Protocol on VivaChek™ Blood Glucose and ß-Ketone Monitoring System. Study results indicated that non-professional, inexperienced lay persons were able to obtain ß-ketone readings when using the VivaChek™ Blood Glucose and β-Ketone Monitoring System. In addition, the participated lay persons were questioned and responded as satisfied with the ease of operation by following User Manual and the overall ketone measurement performance of the VivaChek™ Blood Glucose and β-Ketone Monitoring System.
Conclusion:
The non-clinical (laboratory) studies and clinical (user evaluation) study results have demonstrated that the VivaChek™ Blood Glucose and β-Ketone Monitoring System is safe, effective and easy-to-use, besides it demonstrated that the VivaChek™ Blood Glucose and B-Ketone Monitoring System meets applicable CLSI guidelines, and also based on the similarities described in the table of Comparison to Predicate Device on Technological Characteristics in this 510(k) summary. VivaChek™ Blood Glucose and ß-Ketone Monitoring System is substantially equivalent to the KetoSens Blood ß-Ketone Monitoring System (K170463).
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.