(450 days)
No
The description focuses on the electrochemical measurement method and standard performance testing, with no mention of AI or ML algorithms.
No
This device is a diagnostic device used for monitoring blood glucose levels, not for treating any condition. Its purpose is to measure and provide information.
No
The "Intended Use / Indications for Use" section explicitly states, "The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use."
No
The device description explicitly states it is comprised of a "Blood Glucose Meter" and "Blood Glucose Test Strips," which are hardware components. The performance studies also include testing of the meter and strips.
Based on the provided text, the VivaChek™ Ino Blood Glucose Monitoring System is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The system is designed to "quantitatively measure the glucose concentration in fresh capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: It describes the mechanism of action, which involves a chemical reaction on a test strip with the blood sample to produce an electrical current that is then measured by the meter. This is a typical process for an in vitro diagnostic test.
- Control Solution: The inclusion and description of a control solution for quality control purposes further supports its classification as an IVD. Control solutions are used to verify the performance of IVD devices.
- Clinical Studies: The text mentions clinical studies comparing the system's accuracy to a reference device (YSI Model 2300 STAT PLUS), which is a standard practice for validating the performance of IVD devices.
- Predicate Devices: The listed predicate devices (One Touch Ultra Blood Glucose Monitoring System and LifeScan One Touch Ultra Control Solution) are also IVD devices, indicating that this system falls within the same regulatory category.
Therefore, the VivaChek™ Ino Blood Glucose Monitoring System clearly fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steadystate times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.
The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.
The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) 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 glucose 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 enzyme 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. The meter is calibrated to display plasma-like concentration results.
All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Diabetics, at home, single patient use.
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 VivaChek™ Ino Blood Glucose Monitoring System were evaluated by performing the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, strip accelerated stability, strip real time stability, strip real time use life, control value assignment, control solution accelerated stability, control solution real time stability, control solution real time use life, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.
Clinical Tests Performed:
Clinical studies were conducted with lay persons and trained laboratory technicians using the VivaChek™ Ino Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the VivaChek™ Ino Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the VivaChek Clinical Study Protocol for the Blood Glucose Monitoring System. Study results indicate that non-professional, inexperienced lay persons were able to obtain comparable blood qlucose readings when using the VivaChek™ Ino Blood Glucose Monitoring System. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the VivaChek™ Ino Blood Glucose Monitoring 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
VIVACHEK LABORATORIES, INC. JULIE ZHOU MANAGER OF REGULATORY AFFAIR DEPARTMENT 913 N MARKET STREET, SUITE 200 WILMINGTON DE 19081
Re: K160179
Trade/Device Name: VivaChek Ino Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA. JJX Dated: April 7, 2017 Received: April 10, 2017
Dear Julie Zhou:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160179
Device Name
VivaChek™ Ino Blood Glucose Monitoring System
Indications for Use (Describe)
VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steadystate times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.
The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.
The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly
| 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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3
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 K160179
Submitter's Identification:
VivaChek Laboratories, Inc. 913 N Market Street, Wilmington, DE, 19801, USA
Tel/Fax.: 302-339-8107
Date Prepared: Dec, 2015
Contact Person:
Monica Huang Regulatory Affairs Manager
Proprietary Name of the Device:
VivaChek™ Ino Blood Glucose Monitoring System
Common Name:
Glucose Test System
Classification Name:
Class II §862.1345 Glucose Test System
Predicate Device:
One Touch Ultra Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. K002134
LifeScan One Touch Ultra Control Solution Bionostics, Inc., located at 7Jackson Road, Devens, MA01432, USA. 510(k) Number: K022769
4
| Proprietary Name | Classification | Product
Code | Description | Common
Name |
|-----------------------------------------------------------------------|----------------------|-----------------|--------------------------------------------------|-----------------------------------|
| VivaChek™ Ino Blood
Glucose Monitoring System | 862.1345
Class II | 75 NBW | System, Test, Blood
Glucose, Over The Counter | Glucose Test
System |
| VivaChek™ Ino Blood
Glucose Meter and Blood
Glucose Test Strips | 862.1345
Class II | 75 CGA | Glucose Monitor | Glucose
Meter & Test
Strips |
| VivaChek™ Ino Glucose
Control Solution | 862.1660
Class I | 75 JJX | Single Analyte Control | Control
Solution |
Device Name: VivaChek™ Ino Blood Glucose Monitoring System
Description:
The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) 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 glucose 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 enzyme 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. The meter is calibrated to display plasma-like concentration results.
All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.
Intended Use:
VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood qlucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.
The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.
The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.
5
Technological Characteristics:
Specification of Blood Glucose Meter:
| Feature | Specification |
|---|---|
| Measurement range | 20 to 600 mg/dL |
| Result calibration | Plasma-equivalent |
| Sample | Fresh capillary whole blood |
| Sample volume: | 0.8 µL |
| Test time | 5 seconds |
| Power source | Two (2) CR 2032 3.0 V coin cell batteries |
| Battery life | 12 months or approximately 1,000 tests |
| Glucose units of measure | The meter is pre-set to milligrams per deciliter (mg/dL) |
| Memory | Up to 900 records with date and time |
| Automatic shutoff | 2 minutes after last action |
| Dimensions | 82.5 mm × 52 mm × 18.2 mm |
| Display size | 31mm × 37 mm |
| Weight | Approximately 47g (with battery installed) |
| Operating temperature | 41-113°F |
| Operating relative humidity | 10-90% (non-condensing) |
| Hematocrit range | 20-70% |
| Data Port | mini USB |
Comparison to Predicate Devices:
The VivaChek™ Ino Blood Glucose Monitoring System is substantially equivalent to One Touch Ultra Blood Glucose Monitoring System, K002134.
| Features | VivaChek™ Ino Blood Glucose
Monitoring System | One Touch Ultra Blood Glucose
Monitoring System (K002134) |
|--------------------------------|--------------------------------------------------|--------------------------------------------------------------|
| Similarities | | |
| Assay Method | Glucose oxidase biosensor | Same |
| Strip Chemical
Composition | Glucose oxidase, Mediator | Same |
| Result Calibration | Plasma-equivalent | Same |
| Test Time | 5 seconds | Same |
| Sample Type | Fresh capillary whole blood | Same |
| Glucose Units of
Measure | mg/dL | Same |
| Operating Relative
Humidity | 10-90% | Same |
6
Sponsor: VivaChek Labortatories, Inc.
Address: 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA Contact: Ms. Monica.Huang Email: monica.huang@vivachek.com. Tel / Fax: +1-302-339-8107
| Data Port | mini USB | One Serial data port |
|---|---|---|
| Automatic Shutoff | 2 minutes after last action | Same |
| Differences | ||
| Measurement Range | 20 to 600 mg/dL | 20 to 600 mg/dL |
| Minimum Sample Size | 0.8 μL | 1.0 μL |
| Hematocrit Range | 20–70% | 30–55% |
| Operating | ||
| Temperature | 5-45°C (41-113°F) | 6-44°C (43-111°F) |
| Alternative Sample | ||
| Site for Capillary | Palm and forearm in addition to fingertip | Fingertip and forearm |
| Meter Memory | Up to 900 records with time and date | 150 blood glucose and control solution |
| tests | ||
| Battery Life | 12 months or approximately 1,000 tests | 1,000 tests |
| Power Source | Two (2) CR 2032 3.0V coin cell batteries | One (1) CR 2032 3.0V coin cell battery |
| Meter Size | 82.5 mm × 52 mm × 18.2 mm | 3.12" x 2.25" x 0.85" |
| Meter Weight | Approximately 47g (with battery installed) | 1.5 ounces with battery (Approximately |
| 42 g) |
Comparison to Predicate Control solution
| Similarities and Differences | ||
|---|---|---|
| Item | Proposed Device | |
| VivaChek™ Ino Control Solution | Predicate Device(K022769) | |
| Indications for use | Same | LifeScan One Touch Ultra control |
| solution is intended for use to verify | ||
| verify the performance of blood glucose | ||
| monitoring system. | ||
| The control solution is intended for use | ||
| by healthcare professionals and people | ||
| with diabetes mellitus at home. | ||
| For In Vitro Diagnostic Use | ||
| Analyte | Same | D-glucose |
| Matrix | Buffered aqueous solution of D-glucose, | |
| preservatives and other non-reactive | ||
| ingredients. | Buffered aqueous solution of D-glucose | |
| a viscosity modifier, preservatives and | ||
| other non-reactive ingredients. | ||
| Number of levels | 3 | 1 |
| Target Value | Approximately 50mg/dL for level1, | |
| approximately 120mg/dL for level2 and | ||
| approximately 350mg/dL for level3, | Approximately 115mg/dL | |
| Blood Glucose Meters | VivaChek™ Ino | LifeScan OneTouch Ultra |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Guidance documents included the "FDA Guidance for Industry In Vitro Diagnostic Glucose Test System" and "FDA Guidance for Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems" as well as "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
7
Compliance to applicable voluntary standards includes EN ISO 15197:2013 "In vitro diagnostic test systems – Requirements for in vitro whole blood dlucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."
Laboratory Testing:
The performance characteristics of the VivaChek™ Ino Blood Glucose Monitoring System were evaluated by performing the following studies: repeatability precision, intermediate precision, linearity, interfering agents, hematocrit effect, temperature effect evaluation - blood & control solution, low battery effect, altitude effect, sample volume, humidity effect, simulated shipping study - test strip & control solution, strip accelerated stability, strip real time stability, strip real time use life, control value assignment, control solution accelerated stability, control solution real time stability, control solution real time use life, meter testing, software validation testing, electromagnetic compatibility and electrical safety testing as part of meter and strip validation testing.
Discussion of Clinical Tests Performed:
Clinical studies were conducted with lay persons and trained laboratory technicians using the VivaChek™ Ino Blood Glucose Monitoring System. The study data were presented evaluating the system accuracy of the VivaChek™ Ino Blood Glucose Monitoring System compared to the YSI Model 2300 STAT PLUS (K913806) per the VivaChek Clinical Study Protocol for the Blood Glucose Monitoring System. Study results indicate that non-professional, inexperienced lay persons were able to obtain comparable blood qlucose readings when using the VivaChek™ Ino Blood Glucose Monitoring System. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the VivaChek™ Ino Blood Glucose Monitoring System.
Conclusion:
The laboratory testing and clinical study results demonstrate that the VivaChek™ Ino Blood Glucose Monitoring System is safe, effective and easy-to-use. It also demonstrates that the VivaChek™ Ino Blood Glucose Monitoring System meets the accuracy requirements per EN ISO 15197 and as such is substantially equivalent to the One Touch Ultra Blood Glucose Monitoring System, currently sold on the U.S. market (K002134).