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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Rightest Blood Glucose Monitoring System Wiz and Wiz Plus. It includes details about the device, its intended use, comparison to a predicate device, and summaries of non-clinical and clinical tests performed.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance (Implicit)

The document heavily relies on demonstrating "substantial equivalence" to a predicate device (Rightest GM280 Blood Glucose Monitoring System, K170143). While explicit numerical acceptance criteria for accuracy are not provided in the summary sections, the discussion of non-clinical and clinical tests implies that the device performance must be comparable to or within acceptable limits relative to the predicate device and established standards for glucose monitoring systems. Key performance aspects tested, which would imply related acceptance criteria, include:

Acceptance Criteria (Implied from Tests)	Reported Device Performance (Summary Statements)
Precision (Reproducibility & Repeatability)	Verification and validation activities were performed... Evaluations included precision. Specific numerical results are not provided in this summary, but the conclusion states the device demonstrates substantial equivalence.
Linearity (Accuracy across measurement range)	Verification and validation activities were performed... Evaluations included linearity. Specific numerical results are not provided in this summary, but the conclusion states the device demonstrates substantial equivalence.
Interference (Resistance to interfering substances)	Verification and validation activities were performed... Evaluations included interference. Specific numerical results are not provided in this summary, but a table lists substances and their interference thresholds for both new and predicate devices, suggesting equivalence for: Ascorbic acid > 3 mg/dL, Bilirubin-conjugated >10 mg/dL (for new device), Uric Acid >11.8 mg/dL (for new device), Uric Acid > 12 mg/dL (for predicate).
Sample Volume (Performance with specified minimum volume)	Verification and validation activities were performed... Evaluations included sample volume. Device specs state 0.75 microliter minimum sample volume.
Hematocrit (Performance across a range of hematocrit levels)	Verification and validation activities were performed... Evaluations included hematocrit. Device specs state 20-60% hematocrit range.
User Performance/Usability (Lay user accuracy)	A User performance study was performed to demonstrate that lay users could obtain accurate results using the subject device. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position. The study results demonstrate the usability of Rightest Blood Glucose Monitoring System Wiz and Wiz Plus.

Study Details

Based solely on the provided text, the information is limited, especially regarding detailed methodologies and numerical study outcomes beyond general statements of equivalence.

A table of acceptance criteria and the reported device performance: See the table above. Explicit numerical acceptance criteria are not provided in this summary. The performance is summarized as demonstrating "substantial equivalence" to the predicate.
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the non-clinical or clinical tests. For the User Performance Study, it mentions "capillary whole blood from fingertip, palm and forearm sample sites" but does not give a number of participants or samples.
- Data Provenance: Not explicitly stated. Given the submitter's address (Taiwan), the studies were likely conducted in Taiwan, but this is not confirmed. It is a premarket notification, thus the data would be prospective for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text. The ground truth method for the "User Performance Study" is implied to be a comparison against the predicate device, but the details of the "true" glucose reference method (e.g., lab analyzer) are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned in the provided text.
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: Not applicable. This document is for a Blood Glucose Monitoring System, which is an in-vitro diagnostic device, not an imaging AI device that involves human reader interpretation. No human reader involvement or AI assistance is described for this type of device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), these would inherently be standalone performance evaluations of the device's measurement capabilities.
- The "User Performance Study" evaluates the accuracy when used by lay users, which is a human-in-the-loop performance, but the 'algorithm' (the device's internal measurement system) itself is performing the measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), the ground truth would typically be established using a traceable, highly accurate laboratory reference method (e.g., a YSI analyzer for glucose). This is not explicitly stated but is standard for such evaluations.
- For the User Performance Study, the ground truth is implied to be a reference method (likely a lab analyzer) against which both the new device and the predicate device's readings are compared for equivalence.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the traditional sense of machine learning. It's a glucose monitoring system whose performance is established through empirical testing rather than a learned model.
How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device.

Summary

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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 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

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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

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Indications for Use

510(k) Number (if known) K173139

Device Name

Rightest Blood Glucose Monitoring System Wiz

Indications for Use (Describe)

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)
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Indications for Use

510(k) Number (if known) K173139

Device Name

Rightest Blood Glucose Monitoring System Wiz Plus

Indications for Use (Describe)

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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

1. 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

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

1. Name of the Device: Rightest Blood Glucose Monitoring System Wiz Rightest Blood Glucose Monitoring System Wiz Plus
1. Common or Usual Name: Glucose test system

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	21 CFR 862.1345	Clinical Chemistry 75

1. 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.

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5. Intended Use:

Rightest Blood Glucose Monitoring System Wiz

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 Monitoring System Wiz Plus

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).

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

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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 byindividuals with diabetes at home
MeasurementTechnology	Glucose Oxidase Electrochemical Sensor
Sample Type	Capillary whole blood
minimum samplevolume	0.75 microliter
Primary Site Testing	Fingertip
Alternative SiteTesting	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
Meter StorageConditions	14~140 °F (-10 ~ 60°C)
Test Strip StorageCondition	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-reactiveIngredients 43.5 %
Interference	Ascorbic acid > 3 mg/dLBilirubin-conjugated >10 mg/dLUric Acid >11.8 mg/dL	Ascorbic acid > 3 mg/dLUric Acid > 12 mg/dL
Wireless module	No
Power Saving	Turn off automatically 2 minutes after last user action / Press the main buttonfor 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 withdate and time	500 blood glucose test results with dateand 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 byindividuals with diabetes at home
MeasurementTechnology	Glucose Oxidase Electrochemical Sensor
Sample Type	Capillary whole blood
minimum samplevolume	0.75 microliter
Primary Site Testing	Fingertip
Alternative SiteTesting	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
Meter StorageConditions	14~140 °F (-10 ~ 60°C)
Test Strip StorageCondition	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-reactiveIngredients 43.5 %
Interference	Ascorbic acid > 3 mg/dLBilirubin-conjugated >10 mg/dLUric Acid >11.8 mg/dL	Ascorbic acid > 3 mg/dLUric 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 buttonfor 3 seconds.
Coding	Auto coding
Monitor	LCD display
Backlight	No
Battery Life	1000 tests
Memory Capacity	1000 blood glucose test results withdate and time	500 blood glucose test results with dateand 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

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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.

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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.

Regulation Number and Section

§ 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.