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 RIGHTEST Blood Glucose Test Strip Max is the same as Test Strip Max cleared in K173638.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 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 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 document pertains to the 510(k) premarket notification for the "RIGHTEST Blood Glucose Monitoring System Max Tel." It primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical and clinical tests, particularly outlining the system's accuracy.

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

Acceptance Criteria and Reported Device Performance

The document presents system accuracy results, which serve as the primary performance metrics for the clinical study. The acceptance criteria are implicitly based on the FDA SMBG OTC guidance 2020 (mentioned in the interference section but generally applicable to system accuracy for OTC glucose meters), which typically specifies percentages of results within certain accuracy ranges compared to a reference method.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric (Acceptance Criteria Implicitly from FDA Guidance)	Reported Device Performance (Fingertip)	Reported Device Performance (Palm)	Reported Device Performance (Forearm)
Accuracy within ±15%	98.6% (365 out of 370 tests)	97.2% (360 out of 370 tests)	97.65% (361 out of 370 tests)
Accuracy within ±20%	100%	100%	100%
Accuracy within ±10%	333 out of 370 tests	323 out of 370 tests	316 out of 370 tests
Accuracy within ±5%	231 out of 370 tests	211 out of 370 tests	226 out of 370 tests

Note: For glucose meters, the acceptance criteria often involve percentages of results within +/-15 mg/dL for glucose concentrations < 100 mg/dL and within +/-15% for glucose concentrations >= 100 mg/dL. The document simplifies this to overall percentages within +/-15%, +/-10%, and +/-5% of a reference bias, and mentions 100% within +/-20%. This implies meeting the standard accuracy requirements for blood glucose meters.

Study Details: User Performance Study

1. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 370 participants for the User Performance Study.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, user performance studies for regulatory submissions are typically prospective clinical trials. Given the manufacturer (Bionime Corporation) is based in Taiwan and the regulatory consultant is in the US, it's possible the study was conducted in Taiwan or the US, or both.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document describes a "User Performance Study" where lay users measure glucose. The "System accuracy" section compares these results to a "reference bias" or "comparison method."
No information is provided about experts establishing ground truth in the way one might for an AI-powered diagnostic image analysis system requiring expert annotation. For a blood glucose monitoring system, the "ground truth" or reference method is typically established by laboratory-grade glucose analyzers, often using a method like hexokinase or glucose oxidase with a highly accurate spectrophotometer. These are standardized laboratory procedures, not dependent on expert interpretation. The document mentions "reference bias," further suggesting a comparison to a precise laboratory method.

3. Adjudication Method for the Test Set:

Not applicable in the context of a blood glucose monitoring system's accuracy study. Adjudication typically refers to resolving discrepancies among human readers or between human readers and an AI output in diagnostic imaging studies. Here, the comparison is between the device's reading and a precise laboratory reference method.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging systems where multiple human readers assess cases with and without AI assistance to determine the AI's impact on human performance. For a blood glucose meter, the evaluation is direct device performance against a reference standard, not an improvement in human reader performance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This concept isn't directly applicable in the same way it would be for an AI algorithm. The device itself (the meter and strips) is the "standalone" entity that produces a measurement. The "User Performance Study" assesses the "human-in-the-loop" aspect by having lay users operate the device and measure their own blood samples. The system accuracy results directly report the device's performance as used by humans.

6. The Type of Ground Truth Used:

The ground truth (or reference method) for this blood glucose monitoring system study is implied to be highly accurate laboratory-based glucose measurements, against which the device's readings are compared. The term "reference bias" supports this. For blood glucose meters, this reference is typically a carefully calibrated laboratory instrument, not expert consensus or pathology, which are common for AI-based image analysis.

7. The Sample Size for the Training Set:

Not applicable. This document describes the validation of a blood glucose monitoring system, not an AI or machine learning model that requires a "training set." The system's underlying technology is an electrochemical sensor, not a learned algorithm in the AI sense.

8. How the Ground Truth for the Training Set was established:

Not applicable. As no training set for an AI model is mentioned, there's no ground truth establishment for a training set.

In summary, the document details a traditional validation approach for a medical device (blood glucose monitor) focusing on its accuracy and performance under various conditions, including lay user operation. It does not involve the complex AI-specific testing methodologies (such as MRMC, training sets, or expert adjudication for ground truth) that would be pertinent to AI/ML-driven diagnostic devices.

Summary

{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 seal of the Department of Health & Human Services. 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 are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

January 19, 2024

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

Re: K231192

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: April 27, 2023 Received: April 27, 2023

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" (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).

{1}------------------------------------------------

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 QS 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.

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).

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231192

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)

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}------------------------------------------------

Bionime Corporation

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: K231192

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: January 18, 2024

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

4. Device Description:

{4}------------------------------------------------

ഗ് 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:	K173638

{5}------------------------------------------------

Models	RIGHTEST BGMS Max Tel(New Device)	Rightest BGMS Max Plus(Predicate Device)K173638
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°C), 10 ~ 90% Relative Humidity
Meter Storage Conditions	14~131 °F (-10 ~ 55°C)	14~140 °F (-10 ~ 60°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	(Test according to FDA SMBG OTCguidance 2020)Ascorbic Acid ≥ 3 mg/dLConjugated Bilirubin ≥ 30 mg/dLUric Acid ≥ 12 mg/dLXylose ≥ 8 mg/dL	(Test according to FDA SMBG OTCguidance 2016)Dopamine HCl > 2.3 mg/dLGentisic Acid > 3.0 mg/dLGlutathione reduced > 35 mg/dLHemoglobin > 10,000 mg/dLUric Acid > 10 mg/dLMaltose > 1900 mg/dLXylose > 9.0 mg/dL
Power Saving	Turns off automatically after thedefault time 30 seconds or be set bythe user. To turn off manually, pressthe main button for 2 seconds.	Turn off automatically 2 minutesafter last user action / Press themain button for 3 seconds.
Coding	Auto coding
Monitor	Color LCD	LCD
Backlight	No
Color	black
Power Supply	Non-replaceable and RechargeableLithium battery (3.7 V)	Two CR2032 batteries
Data Transmission	N/A	Bluetooth
Memory Capacity	1000 blood glucose test results with date and time	500 blood glucose test results with date and time
Meter Dimension	60.0 mm x 10.0 mm x 14.0 mm	50.0 mm x 82.0 mm x 15.5 mm
LCD Display Area	2.8-inch touch panel	40.7 mm x 40.2 mm
Meter Weight	95 ± 5g with batteries	59 ± 5 g with batteries

7. Comparison to Predicate Devices:

{6}------------------------------------------------

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence 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 precision, linearity, interference, sample volume, hematocrit and other required item 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	Linearity Evaluation Study
2	Lay user evaluation (Usability Evaluation)
3	EMC Testing
4	Electrical Safety Testing
5	Precision (Within-Run and Intermediate)
6	Specimen Volume Study (Short Sample Detection)
7	Interference Study
8	Operated Altitude study
9	Operated Temperature and Humidity study
10	Hematocrit study
11	Closed Vial Stability Study (Real-Time and Accelerated)
12	Opened Vial Stability Study (Real-Time and Accelerated included)
13	Robustness Cleaning and Disinfection
14	Virucidal Efficacy Report
15	Intermittent Sampling and Sample Perturbation
16	Used Test Strip and Interrupt of Testing
17	Evaluation of Error Message
18	Measure Time Test Function
19	Evaluation of Auto Code Reliability
20	Evaluation of Average Function
21	Battery Power Error and Temperature Error
22	Hi Lo Display
23	Memory Function
24	Power Saving Function
25	Vibration Testing

Sec 8-4 (Rev. 2024/1/18 V4) RIGHTEST BGMS MAX Tel

{7}------------------------------------------------

26	Transportation
27	Software Safety Analysis

9. Discussion of Clinical Tests Performed:

User Performance Study:

A User performance study with 370 participants 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 comparison method used in finger, palm and forearm position.

Layperson	Fingertip:	Palm	Forearm
Glucose range	52.5~537	52.5~537	52.5~537
Test number	370	370	370

System accuracy

RIGHTEST Blood Glucose Monitoring System Max Tel total finger results 98.6% are within the reference bias and 15%, 100% are within the reference bias 20%.

RIGHTEST Blood Glucose Monitoring System Max Tel total palm results 97.2% are within the reference bias and 15%, 100% are within the reference bias 20%.

RIGHTEST Blood Glucose Monitoring System Max Tel total forearm results 97.65% are within the reference bias and 15%, 100% are within the reference bias 20%.

	Finger	Palm	Forearm
Accurate results (+/-15%)	365 out of 370	360 out of 370	361 out of 370
More Accurate results (+/-10%)	333 out of 370	323 out of 370	316 out of 370
Most Accurate results (+/-5%)	231 out of 370	211 out of 370	226 out of 370

10. Conclusions:

Results of performance evaluation of RIGHTEST Blood Glucose Monitoring System Max Tel demonstrate that the device is substantially equivalent to the predicate device, Rightest Blood Glucose Monitoring System MAX Plus.

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.