The Rightest Blood Glucose Monitoring System, Model GM650 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by a single user at home to measure the glucose concentration as an aid to monitor the effectiveness of diabetes control. The glucose concentration is measured with quantitative capillary whole blood (from the fingertip, palm, and forearm), by using Rightest Blood Glucose Monitoring System, GM650.

This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. And this device should not be used for testing multiple patients. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strips GS650 are intended for use with the Rightest Blood Glucose meter GM650 in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.

Rightest Control Solutions GC650 are intended for use with the Rightest Blood Glucose Monitoring System. Model GM650 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only.

The Rightest Blood Glucose Monitoring System GM650 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. The Rightest Blood Glucose Monitoring System GM650 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 Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The Rightest Control Solution Set GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS650 to check that the meters and test strip are working together properly and that the test is performing correctly.

The GE talking blood glucose monitoring system Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE talking blood glucose monitoring system Model GE300 is intended for single patient use only.

The GE talking blood glucose monitoring system Model GE300 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. The GE talking blood glucose monitoring system Model GE300 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 GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.

Device Description

Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Three Control Solutions, Lancing Device and Lancets.

The Rightest Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.

Bionime's Rightest™ GM650 system is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with FAD-glucose Dehydrogenase (FAD-GDH) which interacts with the software driven digital talking meter. Within five seconds, the level of blood glucose will be shown on the digital display screen.

Rightest™ Blood Glucose Monitoring System, with an auto-coding feature, requires only minimum of I microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Bionime Rightest Blood Glucose Monitoring System, Model GM650, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the Rightest Blood Glucose Monitoring System Model GM650 "met the acceptance criteria" for its accuracy study. However, it does not explicitly list the quantitative acceptance criteria for blood glucose monitoring systems (e.g., specific percentages within certain glucose ranges). Without those specific criteria, a table comparing them to reported performance cannot be fully constructed.

What is present:

Performance Metric	Reported Device Performance	Acceptance Criteria
System Accuracy	"met the acceptance criteria"	Not explicitly stated in the document. (Typically involves standards like ISO 15197 or FDA guidance for glucose meters, e.g., ±15% or ±15 mg/dL for specified percentages of readings).
User Performance	"shows substantial equivalence to Rightest Blood Glucose Monitoring System used in finger, palm and forearm position"	Not explicitly stated in the document. (Implies achieving similar accuracy levels as the predicate device when used by lay users from multiple sites).

Study Details:

Sample sizes used for the test set and data provenance:
- System Accuracy Study: 118 patients. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it's implied to be a prospective clinical study involving patient samples.
- User Performance Study: 161 consumers. The provenance is not specified, but it's implied to be a prospective study involving lay users.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The ground truth for the System Accuracy Study was established by "plasma glucose values on a lab instrument." This implies a reference laboratory method and instrument, not human experts. The qualifications of the operators of the lab instrument are not specified.
- For the User Performance Study, the ground truth would also be the "lab instrument" readings, as the study aims to show that lay users can obtain accurate results compared to a reference method, not necessarily compared to expert interpretation of the device's output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method involving multiple experts is described for either the System Accuracy Study or the User Performance Study. The ground truth relies on a single laboratory reference instrument.
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:
- No MRMC comparative effectiveness study was done or is described in the summary. This type of study is not relevant for a blood glucose monitoring system, which provides a direct quantitative reading rather than images or data requiring interpretation by human readers, or AI-assisted interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "System Accuracy Study" can be considered a standalone performance evaluation of the device (meter + strip) which incorporates the algorithm to generate a glucose reading. It compares the device's output directly to a reference method, without human interpretation of the device's reading as part of the primary outcome. The "User Performance Study" assesses the "human-in-the-loop" aspect by having lay users operate the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the System Accuracy Study, the ground truth was "plasma glucose values on a lab instrument." This is a laboratory-based reference method, considered highly accurate for glucose measurement.
- For the User Performance Study, the ground truth would implicitly be the same "plasma glucose values on a lab instrument," serving as the benchmark against which lay user results are compared.
The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. This type of device (blood glucose meter with a fixed algorithm) typically undergoes development and internal validation, but a distinct "training set" as understood in machine learning is not usually detailed in such regulatory summaries for these types of devices. The "verification and validation of test results" mentioned generally refers to the internal development and testing processes prior to clinical studies.
How the ground truth for the training set was established:
- Since no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided. The development process would have involved rigorous testing against calibrated reference standards and established laboratory methods.

Summary

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K120423

510(k) SUMMARY Bionime Rightest Blood Glucose Monitoring System, Model GM650

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92(C)

3 2012 AUG

The Assigned 510(k) number is:

Date of Summary: February 9th, 2012

Common Name: Rightest™ Blood Glucose Monitoring System, Model GM650

Regulatory Information:

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	21 CFR 862.1345	75 - Chemistry
LFR; Glucose Dehydrogenase,Glucose	Class II	21 CFR 862.1345	75 - Chemistry
JJX; single (specified) analytecontrols (assayed and unassayed)	Class I	21 CFR 862.1660	75- Chemistry

Applicant:

Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268 Fax: 886 - 4 - 2495-2568

Contact Persons:

Primary Contact:

Mrs. Feng-Yu Lee Correspondent for this Application Bionime Corporation c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: (949) 951-3046 Fax: (949) 951-2042 fengyulee@ivddreg.com

Alternate Only:

Ms. Mandy Chiu Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268, ext 895 Fax: 886 - 4 - 2495-2568 Mandy.Chiu@bionime.com

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510(k) SUMMARY (Cont.)

Identification / Product Name:

Blood Glucose Monitoring System

Device Description:

Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Three Control Solutions, Lancing Device and Lancets.

Intended Use:

Predicate Kit:

The Bionime Diabetes Management System is substantially equivalent to the predicate device noted below:

Device Name: Rightest™ Blood Glucose Monitoring System, Model GM550

510k No.: K092052 Device Company: Bionime Corporation

Bionime Corporation - Blood Glucose Monitoring System GM650/GE300

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510(k) SUMMARY (Cont.)

Technology Characteristics:

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of the Rightest Blood Glucose Monitoring System. The evaluation included precision, linearity, interference and hematocrit.

Discussion of Clinical Tests Performed:

System Accuracy Study:

The accuracy study of the Rightest" Blood Glucose Monitoring System Model GM650 was performed by comparing whole blood (plasma equivalent) glucose values on the Rightest™ meter with plasma glucose values on a lab instrument.

A total of 118 patients were participated. The study result demonstrates that the accuracy of Rightest " Blood Glucose Monitoring System Model GM650 met the acceptance criteria.

User Performance Study:

A User performance study was performed to demonstrate that lay consumers could obtain accurate results using the subject device. The study was performed by 161 consumers testing capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to Rightest Blood Glucose Monitoring System used in finger, palm and forearm position.

Performance:

The results of aforementioned studies demonstrate satisfactory performance of Bionime Rightest™ Blood Glucose Monitoring System GM650, and the device is easy to use and the results are understandable by the target users.

Conclusion:

The results of the verification and validation studies of the Bionime Diabetes Management System demonstrated that the product is safe and effectiveness in the hands of lay users and health care professionals. The product is substantial equivalence to the predicate device, Rightest Blood Glucose Monitoring System Model GM550.

Bionime Corporation - Blood Glucose Monitoring System GM650/GE300

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure with three overlapping profiles. The profiles are arranged in a way that suggests movement or progression.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Bionime Corporation c/o Feng-Yu Lee IVDD Regulatory Consultant 27001 La Paz Road, Suite 266B Mission Viejo, CA 92691

AUG 3 2012

K120423 Re:

Trade Name: Bionime Rightest™ Blood Glucose Monitoring System, Model GM650 GE Talking Blood Glucose Monitoring System, Model GE300

Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: July 9, 2012 Received: July 23, 2012

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1111), it nay 06 add 500 in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal 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 moun that I Drims and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration 1 ou interest 80mps) (17th Part 807); labeling (21 CFR Parts 801 and 809); medical device and noming (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

$\qquad$

Steven H. Lipton, Ph.D.

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120423

Rightest Blood Glucose Monitoring System, Model GM650 Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division Sign-O

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120423

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Indications for Use

510(k) Number (if known): K120423

GE talking blood glucose monitoring system, Model GE300 Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page Dof

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120423

Bionime Corporation - Blood Glucose Monitoring System GM650/GE300

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.