RIGHTEST Blood Glucose Monitoring System Max Tel is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole 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 Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor 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).

The RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

Device Description

RIGHTEST Blood glucose monitoring System Max Tel 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.

RIGHTEST Blood Glucose Meter Max Tel, when used with the RIGHTEST Blood Glucose Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of RIGHTEST Blood Glucose Monitoring System Max Tel is verified by the RIGHTEST Control Solution GC700.

The glucose measurement is achieved by using the amperometric detection meth 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 FAD-glucose dehydrogenase 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.

AI/ML Overview

The provided FDA 510(k) summary for the RIGHTEST Blood Glucose Monitoring System Max Tel focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical study results typical of a de novo or PMA submission. Therefore, much of the requested information regarding a comprehensive study proving acceptance criteria for an AI/device for diagnostic purposes (e.g., number of experts, MRMC studies, ground truth establishment for a training set) is not directly present in this document because it is not an AI/Software as a Medical Device (SaMD) submission for a diagnostic algorithm.

This document describes a glucose monitoring system, which is a medical device rather than an AI-powered diagnostic system that typically involves image analysis or complex algorithmic interpretations of patient data for diagnosis. The "Software Safety Analysis" refers to enabling LTE functionality and adjusting the measurement range, alongside cybersecurity considerations, not the performance of a diagnostic AI.

However, I can extract the acceptance criteria and performance as described in the document for this specific device:

Device: RIGHTEST Blood Glucose Monitoring System Max Tel
Intended Use: Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples for self-testing by people with diabetes at home, as an aid to monitor the effectiveness of diabetes control.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Discussion of Non-Clinical Tests Performed for Determination of Substantiability" (Section 8) and the "Comparison to Predicate Devices" (Section 7), the acceptance criteria are generally implied by the successful completion and compliance with relevant FDA guidelines for glucose monitoring systems. The performance is reported in terms of demonstrating compliance.

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Accuracy / Performance Verification: Compliance with FDA's accuracy guidelines for Over-the-Counter (OTC) Self-Monitoring Blood Glucose (SMBG) systems. (This is a primary performance metric for glucose meters, though specific numerical targets like ISO 15197 are not detailed in this summary, they are implicit for regulatory acceptance.)	The Extreme Glucose Study: "A study conducted on glucose performance using both natural and modified blood samples. The results demonstrated compliance with the FDA's accuracy guidelines for Over-the-Counter (OTC) Self-Monitoring Blood Glucose (SMBG) systems." Overall Conclusion: "Results of performance evaluation of RIGHTEST Blood Glucose Monitoring System Max Tel that had no impacts to BGM measurement was conducted to support substantially equivalent to the predicate device..."
Measurement Range: Correct display of "Hi" or "Lo" for out-of-range results.	Hi Lo Display: "The measurement range has been adjusted, and the system displayed a notification indicating 'Hi' or 'Lo'—for results that fall outside the established range." The specific numerical range is 20 - 600 mg/dL (1.1 - 33.3 mmol/L).
Software Functionality and Safety: - Successful implementation and validation of LTE functionality. - Compliance with FCC testing. - Compliance with FDA's cybersecurity guidance.	Software Safety Analysis: "Software adjustments were made to enable LTE functionality and adjusted the measurement range. The LTE function was validated through both FCC compliance testing and laboratory testing. As LTE functionality introduced cybersecurity considerations, we ensured compliance with the FDA's guidance on the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Interference: Performance maintained in the presence of specified interferents.	Interference Data Points: Ascorbic Acid ≥ 3 mg/dL, Conjugated Bilirubin ≥ 30 mg/dL, Uric Acid ≥ 12 mg/dL, Xylose ≥ 8 mg/dL. (Implies performance within specification despite these levels, though the exact outcome of the testing is not described beyond listing the tested interferents)
Other Functional Parameters: Measurement technology, sample type, minimum sample volume, test time, control solution compatibility, operating conditions, storage conditions, shelf life, reagent composition, power saving, coding, monitor, backlight, color, power supply, memory capacity, meter dimension, LCD display area, meter weight, data transmission.	All these parameters are listed as characteristics of the new device, implicitly meeting the predicate device's standards or being deemed acceptable (e.g., LTE network for data transmission is a new feature).
General Acceptance: All laboratory studies met acceptance criteria.	"All laboratory studies that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable."

Regarding the other requested points (relevant for AI/SaMD):

2. Sample sized used for the test set and the data provenance: Not specified in the provided document. The reference to "natural and modified blood samples" in "The Extreme Glucose Study" suggests lab-based testing, but no specific sample size or provenance is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/diagnostic imaging device requiring expert ground truth for interpretation. Ground truth for a glucose meter is typically established by laboratory reference methods (e.g., YSI analyzer).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is usually for subjective interpretations by multiple human readers, not for a highly objective measurement device like a glucose meter.
5. 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 is not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a "standalone" measurement device. Its performance is measured directly against laboratory reference standards, but there is no "algorithm only" in the sense of an AI interpreting complex data that a human would usually interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For glucose meters, the ground truth is typically a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus or pathology, as the measurement is quantitative. This is implied by the nature of the device, although not explicitly stated as "YSI" in the document.
8. The sample size for the training set: Not applicable. This device does not use machine learning with a distinct training set in the typical sense of an AI/ML algorithm. Its functionality is based on established electrochemical principles, not pattern recognition learned from a dataset.
9. How the ground truth for the training set was established: Not applicable, for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a blood glucose monitoring system, emphasizing its substantial equivalence to a predicate device and compliance with general FDA guidelines for such devices. It does not contain the detailed study results and AI-specific ground truth methodologies that would be found in a submission for an AI-powered diagnostic device.

Summary

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November 4, 2024

Bionime Corporation % Feng-Yu Lee Principal Regulatory Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29122 Rancho Vieio Road. Suite 212 San Juan Capistrano, California 92675

Re: K240637

Trade/Device Name: RIGHTEST Blood Glucose Monitoring System Max Tel Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: October 3, 2024 Received: October 3, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240637

Device Name

RIGHTEST Blood Glucose Monitoring System Max Tel

Indications for Use (Describe)

RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor 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).

The RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

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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BIONIME

510(K) SUMMARY

This summary of 5/0(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: K240637

1. Submitter's Identification:

BIONIME CORPORATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Contact Person: Phone Number: 886-4-23692388, Ext:5898 FAX Number: 886-4-22617568

c/o Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 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: November 1, 2024

1. Name of the Device: RIGHTEST Blood glucose monitoring System Max Tel

3. 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

4. Device Description:

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5. Intended Use:

RIGHTEST Blood Glucose Monitoring System Max Tel 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 Max Tel 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).

The RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

6. Predicate Device Information:

RIGHTEST Blood Glucose Monitoring System Max Tel is substantially equivalent to the brand of RIGHTEST Blood Glucose Monitoring System Max Plus noted as 6.1.

6.1
Name:	RIGHTEST Blood Glucose Monitoring System Max Plus
Device Company:	Bionime Corporation
510(K) Number:	K231192

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Image /page/6/Picture/0 description: The image shows the word "BIONIME" in a stylized, sans-serif font. The letters are a uniform gray color, and the overall design is clean and modern. The letters are evenly spaced and appear to be slightly rounded.

Comparison to Predicate Devices:

Models	RIGHTEST BGMS Max Tel(New Device)	RIGHTEST BGMS Max Tel(Predicate Device)K231192
MeasurementTechnology	Dehydrogenase Electrochemical Sensor
Sample Type	Fresh capillary whole blood
Alternative Sample Site	The fingertips, palm, forearm.
Minimum SampleVolume	0.75 microliter
Test Time	5 seconds
Control Solution	3 levels (Level 1, 2, and 4)RIGHTEST Control Solution GC700
Operating Conditions	Temperature 43 ~111 °F (6 ~ 44℃), 10 ~ 90% Relative Humidity
Meter Storage Conditions	14 ~131 °F (-10 ~ 55°C)
Test Strip Shelf Life (AfterOpening)	4 months
Test Strip Reagent	1. FAD-Glucose dehydrogenase 12.4 %2. Potassium Ferricyanide 49.6 %3. Non-reactive Ingredients 38.0 %
Interference	Ascorbic Acid ≥ 3 mg/dLConjugated Bilirubin ≥ 30 mg/dLUric Acid ≥ 12 mg/dLXylose ≥ 8 mg/dL
Power Saving	Turns off automatically after the default time 30 seconds or be set by theuser. To turn off manually, press the main button for 2 seconds.
Coding	Auto coding
Monitor	Color LCD
Backlight	No
Color	black
Power Supply	Non-replaceable and Rechargeable Lithium battery (3.7 V)
Memory Capacity	1000 blood glucose test results with date and time
Meter Dimension	60.0 mm x 10.0 mm x 14.0 mm
LCD Display Area	2.8-inch touch panel
Meter Weight	95 ± 5g with batteries
Data Transmission	LTE network	NA
Measuring Range	20 - 600 mg/dL (1.1 - 33.3 mmol/L)	50 - 550 mg/dL (2.8 - 30.6 mmol/L)

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8. Discussion of Non-Clinical Tests Performed for Determination of Substanti is as follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of RIGHTEST Blood Glucose Monitoring System Max Tel. The evaluation included Hi and Lo Display, Extreme Glucose Study, Software Safety Analysis, FCC report, LTE function and Cybersecurity Evaluation specified in the FDA SMBG OTC guidance.

All laboratory studies that the acceptance criteria were met. Therefore, the performances from these laboratory studies were acceptable

No.	Test/Validation Item
1	Hi Lo Display
2	The Extreme Glucose Study
3	Software Safety Analysis (FCC report, LTE function, Cybersecurity Evaluation)

Hi Lo Display

The measurement range has been adjusted, and the system displayed a notificationindicating "Hi" or "Lo"—for results that fall outside the established range.

The Extreme Glucose Study

A study conducted on glucose performance using both natural and modified blood samples. The results demonstrated compliance with the FDA's accuracy guidelines for Over-the-Counter (OTC) Self-Monitoring Blood Glucose (SMBG) systems.

Software Safety Analysis

Software adjustments were made to enable LTE functionality and adjusted the measurement range. The LTE function was validated through both FCC compliance testing and laboratory testing. As LTE functionality introduced cybersecurity considerations, we ensured compliance with the FDA's guidance on the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

9. Conclusions:

Results of performance evaluation of RIGHTEST Blood Glucose Monitoring System Max Tel that had no impacts to BGM measurement was conducted to support substantially equivalent to the predicate device, RIGHTEST Blood Glucose Monitoring System MAX Tel.

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.