(263 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
The device is used for monitoring blood glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition, thus it is not a therapeutic device.
No
The device is explicitly stated as "not to be used for the diagnosis of, or screening for diabetes." Instead, it is intended to "monitor the effectiveness of diabetes control" for people already diagnosed with diabetes, indicating a monitoring rather than a diagnostic function.
No
The device description explicitly lists hardware components: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device, and Sterile Lancets. While there is a Bluetooth function for wireless transfer, the core system relies on physical hardware for glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "Rightest Blood Glucose Monitoring System Wiz is intended for self- testing outside the body (in vitro diagnostic use)..." and "Rightest Blood Glucose Monitoring System Wiz Plus is intended for self- testing outside the body (in vitro diagnostic use)...".
This clearly indicates that the device is designed to be used for testing biological samples (blood) outside of the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
Rightest Blood Glucose Monitoring System Wiz is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
Rightest Blood Glucose Monitoring System Wiz Plus is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz Plus is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
Rightest Blood Glucose Monitoring System Wiz and Wiz Plus are identical with the exception of Bluetooth function for Rightest Blood Glucose Monitoring System Wiz Plus, which allows for wireless information transfer.
Rightest Blood Glucose Monitoring System Wiz and Wiz Plus consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device, and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single person, self- testing outside the body (in vitro diagnostic use) by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
User Performance Study: A User performance study was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position. The study results demonstrate that the usability of Rightest Blood Glucose Monitoring System Wiz and Wiz Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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 19, 2018
Bionime Corporation % Feng-Yu Lee Principal Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675
Re: K173139
Trade/Device Name: Rightest Blood Glucose Monitoring System Wiz Rightest Blood Glucose Monitoring System Wiz Plus Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 15, 2018 Received: May 18, 2018
Dear Feng-Yu Lee:
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, 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) K173139
Device Name
Rightest Blood Glucose Monitoring System Wiz
Indications for Use (Describe)
Rightest Blood Glucose Monitoring System Wiz is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Wiz Blood Glucose Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
| 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K173139
Device Name
Rightest Blood Glucose Monitoring System Wiz Plus
Indications for Use (Describe)
Rightest Blood Glucose Monitoring System Wiz Plus is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz Plus is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
| 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) |
===
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: K173139
-
- Submitter's Identification:
BIONIME CORPORRATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Phone Number: 886-4-23692388 FAX Number: 886-4-22617568
- Submitter's Identification:
c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928
Date Summary Prepared: June 18th, 2018
-
- Name of the Device: Rightest Blood Glucose Monitoring System Wiz Rightest Blood Glucose Monitoring System Wiz Plus
-
- Common or Usual Name: Glucose test system
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW; System, Test, Blood | |||
| Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry 75 |
-
- Device Description:
Rightest Blood Glucose Monitoring System Wiz and Wiz Plus are identical with the exception of Bluetooth function for Rightest Blood Glucose Monitoring System Wiz Plus, which allows for wireless information transfer.
- Device Description:
Rightest Blood Glucose Monitoring System Wiz and Wiz Plus consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device, and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
5
5. Intended Use:
Rightest Blood Glucose Monitoring System Wiz
Rightest Blood Glucose Monitoring System Wiz is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
Rightest Blood Glucose Monitoring System Wiz Plus
Rightest Blood Glucose Monitoring System Wiz Plus is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.
Rightest Blood Glucose Monitoring System Wiz Plus is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.
6. Predicate Device Information:
Rightest Blood Glucose Monitoring System Wiz and Wiz Plus are substantially equivalent to the models of Rightest Blood Glucose Monitoring System noted below.
| Name: | Rightest GM280 Blood Glucose Monitoring System |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K170143 |
6
7. Comparison to Predicate Devices:
7.1 Specification Comparison – Rightest Wiz vs. Rightest GM280
| Models | Rightest BGMS Wiz
(New Device) | Rightest BGMS GM280
(Predicate Device) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | Over-The-Counter: For single-patient use only, in-vitro diagnostic use only by
individuals with diabetes at home | |
| Measurement
Technology | Glucose Oxidase Electrochemical Sensor | |
| Sample Type | Capillary whole blood | |
| minimum sample
volume | 0.75 microliter | |
| Primary Site Testing | Fingertip | |
| Alternative Site
Testing | Forearm, Palm | |
| Unit of Measurement | mg/dL | |
| Measuring Range | 20-600 mg/dL | |
| Test Time | 5 seconds | |
| Hematocrit | 20-60 % | |
| Control Solution | 3 levels (Level 1, 2, and 4)
Rightest Control Solution GC550 | |
| Maximum Altitude | 10745 feet (3275 m) | |
| Operating Conditions | Temperature 50 104 °F (10 ~ 40°C), 10 ~ 90% Relative Humidity | |140 °F (-10 ~ 60°C) | |
| Meter Storage
Conditions | 14
| Test Strip Storage
Condition | 39~86 °F (4 ~ 30°C), 10-90% relative humidity | |
| Test Strip Shelf Life
(After Opening) | 3 months | |
| Test Strip Reagent | Glucose Oxidase (GOD) 18.8 % Potassium Ferricyanide 37.7 % Non-reactive
Ingredients 43.5 % | |
| Interference | Ascorbic acid > 3 mg/dL
Bilirubin-conjugated >10 mg/dL
Uric Acid >11.8 mg/dL | Ascorbic acid > 3 mg/dL
Uric Acid > 12 mg/dL |
| Wireless module | No | |
| Power Saving | Turn off automatically 2 minutes after last user action / Press the main button
for 3 seconds. | |
| Coding | Auto coding | |
| Monitor | LCD display | |
| Backlight | No | |
| Battery Life | 1000 tests | |
| Power Supply | One CR2032 battery | |
| Memory Capacity | 1000 blood glucose test results with
date and time | 500 blood glucose test results with date
and time |
| Meter Dimension | 50.0 mm x 82.0 mm x 15.5 mm | 82mm45mm15.5mm |
| LCD display area | 40.7 mm x 40.2 mm | 34 mm*27.5mm |
| Meter Weight | 59 ± 5g with batteries | 43.0± 5g with batteries |
| Color | white/black | white/gray |
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7.2 Specification Comparison – Rightest Wiz Plus vs. Rightest GM280
| Models | Rightest BGMS Wiz Plus
(New Device) | Rightest BGMS GM280
(Predicate Device) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | Over-The-Counter: For single-patient use only, in-vitro diagnostic use only by
individuals with diabetes at home | |
| Measurement
Technology | Glucose Oxidase Electrochemical Sensor | |
| Sample Type | Capillary whole blood | |
| minimum sample
volume | 0.75 microliter | |
| Primary Site Testing | Fingertip | |
| Alternative Site
Testing | Forearm, Palm | |
| Unit of Measurement | mg/dL | |
| Measuring Range | 20-600 mg/dL | |
| Test Time | 5 seconds | |
| Hematocrit | 20-60 % | |
| Control Solution | 3 levels (Level 1, 2, and 4)
Rightest Control Solution GC550 | |
| Maximum Altitude | 10745 feet (3275 m) | |
| Operating Conditions | Temperature 50 104 °F (10 ~ 40°C), 10 ~ 90% Relative Humidity | |140 °F (-10 ~ 60°C) | |
| Meter Storage
Conditions | 14
| Test Strip Storage
Condition | 39 ~86 °F (4 ~ 30°C), 10-90% relative humidity | |
| Test Strip Shelf Life
(After Opening) | 3 months | |
| Test Strip Reagent | Glucose Oxidase (GOD) 18.8 % Potassium Ferricyanide 37.7 % Non-reactive
Ingredients 43.5 % | |
| Interference | Ascorbic acid > 3 mg/dL
Bilirubin-conjugated >10 mg/dL
Uric Acid >11.8 mg/dL | Ascorbic acid > 3 mg/dL
Uric Acid > 12 mg/dL |
| Wireless Module | Yes, via low energy Bluetooth | |
| Power Saving | Turn off automatically 2 minutes after last user action / Press the main button
for 3 seconds. | |
| Coding | Auto coding | |
| Monitor | LCD display | |
| Backlight | No | |
| Battery Life | 1000 tests | |
| Memory Capacity | 1000 blood glucose test results with
date and time | 500 blood glucose test results with date
and time |
| Power Supply | Two CR2032 batteries | One CR2032 battery |
| Meter Dimension | 50.0 mm x 82.0 mm x 15.5 mm | 82 mm45 mm15.5 mm |
| LCD display area | 40.7 mm x 40.2 mm | 34 mm*27.5 mm |
| Meter Weight | 59 ± 5g with batteries | 43.0± 5g with batteries |
| Color | white/black | white/gray |
| Bluetooth | Yes | No |
8
Bionime Corporation
Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence is as follows:
Verification and validation activities were performed on Rightest BGMS Wiz/Wiz Plus to establish performance, functionality, and reliability of the device system. Evaluations included precision, linearity, interference, sample volume and hematocrit.
9
9. Discussion of Clinical Tests Performed:
User Performance Study:
A User performance study was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position.
The study results demonstrate that the usability of Rightest Blood Glucose Monitoring System Wiz and Wiz Plus.
10. Conclusions:
Results of performance evaluation of Rightest Blood Glucose Monitoring System Wiz and Wiz Plus demonstrate that the device is substantially equivalent to the predicate device Rightest GM280 Blood Glucose Monitoring System.