The Rightest Blood Glucose Monitoring System GM700 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 GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 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 GM700 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 GS700 is for use with the Rightest Blood Glucose meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.

The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strips GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.

Device Description

Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System GM700, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states that the device "met the acceptance criteria" for the system accuracy study. It does not numerically list the specific acceptance criteria for blood glucose monitoring systems, nor does it provide a direct numerical performance result. In the absence of a detailed table from the source, I will indicate the general finding.

Metric (Implied)	Acceptance Criteria (Not explicitly stated in text but generally understood for BGMS)	Reported Device Performance
System Accuracy	(General criteria for blood glucose monitoring systems, not provided in this text)	Met the acceptance criteria
User Performance	(Criteria for lay user accuracy, not provided in this text)	Lay consumers could obtain accurate results

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Accuracy Study: 103 patients
Sample Size for User Performance Study: Not explicitly stated, but implies a sufficient number of lay consumers participated.
Data Provenance: Not explicitly stated, but the submission is from a Taiwanese company (BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412), suggesting the studies may have been conducted in Taiwan or a related region. It does not specify if the data was retrospective or prospective, but clinical studies are generally prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The ground truth for the accuracy study was established by "plasma glucose values on a lab instrument," implying trained laboratory personnel were involved, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The text does not mention an adjudication method (such as 2+1 or 3+1) for establishing the ground truth. The ground truth was based on a "lab instrument" for plasma glucose values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a medical device (blood glucose monitor), not an AI algorithm assisting human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a Blood Glucose Monitoring System, which includes the meter, test strips, and control solution, and is used by a human. The "standalone" concept typically applies to AI algorithms. The system itself is the "standalone" diagnostic tool.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the system accuracy study was established using "plasma glucose values on a lab instrument." This is a reference measurement, often considered a highly accurate and standardized method for glucose determination.

8. The Sample Size for the Training Set

Blood Glucose Monitoring Systems are typically developed through electrochemical and hardware engineering, and thus do not involve a "training set" in the context of machine learning. Therefore, a sample size for a training set is not applicable to this device.

9. How the Ground Truth for the Training Set Was Established

As the concept of a "training set" is not applicable to the development of this device, the question of how its ground truth was established is not applicable. Device performance is validated against established laboratory reference methods and clinical accuracy standards, rather than "training" an algorithm.

Summary

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MAR 2 9 2012

510(K) SUMMARY

This summary of 5l0(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: K110737

Submitter's Identification: 1.

BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412 Contact Person: __Mr. Roy Huang Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: March 26, 2011

Name of the Device: Rightest Blood Glucose Monitoring System GM700 2.
Common or Usual Name: Glucose test system 3.

Device Product Code	Device Class	Panel/ Regulationnumber
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	Clinical Chemistry21 CFR 862.1345
LFR; Glucose Dehydrogenase,Glucose	Class II	Clinical Chemistry21 CFR 862.1345
JJX; single(specified) analytecontrols (assayed and unassayed)	Class I	Clinical Chemistry21 CFR 862.1660

Device Description: 4.

Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Fightest Dioba Chaoooo motor ontitatively measures glucose in fresh capillary Glucose Test Stinpo Gol oo, Quartest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

A Rightest Blood Glucose Monitoring System GM700 kit box may contain different bundled items.

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ട. Intended Use:

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole for the quantitative mithe fingertips, palm and forearm. The Rightest Blood Samples arawn from them GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self The Fightest Diood Chood City (in vitro diagnostic use) by people with diabetes at home tes an aid to monitor the effectiveness of diabetes control. The Rightest Blood as an all to monitor nystem GM700 should not be used for the diagnosis of, or Quoose Mornitoring Oyotom ann other or in othernative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Control Solution GC700 is for use with the Rightest Blood Glucose meter GM700 and Rightest Blood Glucose Test Strip GS700 to check that the meters and test strip are working together properly and that the test is performing correctly.

Predicate Device Information: 6.

The Rightest Blood Glucose Monitoring System Model GM700 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

Rightest Blood Glucose Monitoring System Model GM550 Name: Device Company: Bionime Corporation 510(K) Number: K092052.

Comparison to Predicate Devices: 7. ·

Specification Comparison

Similarities
Item	Rightest BGMS GM700(New Device)	Rightest BGMS GM550(Predicate Device K092052)
Minimum Sample Volume	1.0 microliter
Test Time	5 seconds

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Measuring Range	20-600 mg/dL
Operating Relative Humidity	10 ~ 90%
Battery Life	About 1000 tests
Monitor	LCD display
Meter Storage Conditions	-10 ~ 60°C (14 ~ 140 °F)
Test Strip Storage Conditions	4 ~ 30°C (39 ~ 86 °F), <90% relative humidity
The unit of measurement	Fix on mg/dL
Sample	Capillary whole blood

Specification Comparison

Specification Comparison	Differences
Item	Rightest BGMS GM700(New Device)	Rightest BGMS GM550(Predicate Device K092052)
Interference	Uric acid $\ge$ 10 mg/dLXylose $\ge$ 10 mg/dL	Uric acid $\ge$ 10 mg/dL
Memory Capacity	1000 blood glucose test results withdate and time	500 blood glucose test results withdate and time
Power Supply	One CR2032 battery	Two CR2032 batteries
Power Saving	Press the main button for 3 seconds.	Press the main button for 4 seconds.
Meter Dimension	99 mm × 46 mm × 17.5 mm	90.6 mm × 46 mm × 16.5 mm
Meter Weight	57.0 ± 5 g with battery	53.0 ± 5 g with batteries
Coding	Smart autocoding	Auto coding
Hematocrit Range	30-55%	30 - 60%
LCD display area	52.6 mm × 32 mm	47 mm × 33.5 mm
Strip Reagent	1.FAD-glucose Dehydrogenase(FAD-GDH) 9.0%2.Potassium ferricyanide 53.7%3.Non-reactive ingredients 37.3%	1.Glucose Oxidase (GOD) 14.8%2.Potassium ferricyanide 39.5%3.Non-reactive ingredients 45.7%
Measurement Technology	Dehydrogenase ElectrochemicalSensor	Oxidase Electrochemical Sensor
Operating TemperatureRange	6 ~ 44 °C (43 ~ 111 °F)	10 ~ 40 °C (50 ~ 104 °F)
Back Light	No	yes

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L1, L2, L3, L4, L5

Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:

Verification and validation of test results were evaluated to establish the verformance, functionality and reliability of the Rightest Blood Glucose Monitoring penomance, and onalism included precision, linearity, interference and hematocrit.

Discussion of Clinical Tests Performed: 9.

System Accuracy Study:

The accuracy study of the Rightest Blood Glucose Monitoring System GM700 was The accuracy study of the mgmostoon (plasma equivalent) glucose values on the Rightest meter with plasma glucose values on a lab instrument.

I lightest meter with plasma gravere participated. The study result demonstrates that the A lotal of 103 patients word particisco. Monitoring System GM700 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 using obtain acounts foodite an fingertip, palm and forearm sample sites. The study capillary while blood from lingenip) position in the manitoring System GM700 used in finger, palm and forearm position.

10. Conclusions:

Results of performance evaluation of the Rightest Blood Glucose Monitoring System Hesults of performance overaliantial equivalence to the predicate GMT 00 Glucose Monitoring System Monitoring System Model GM550.

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Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bionime Corporation c/o MDI Consultant, Inc c/o Jigar Shah 55 Northern Blvd, Suite 200 Great Neck. New York 11021

MAR 2 9 2012

K110737 . Re:

Trade Name: Rightest Blood Glucose Monitoring System GM700 -Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, JJX, LFR Dated: March 26, 2012 Received: March 27, 2012

Dear Jigar Shah:

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 approval approvisions of the Act. The general controls provisions of the Act include controls providents of the stration, 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 (I Mry, it may be subject to tack 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device bar be roam blish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I touse be ac not a made a determination that your device complies with other requirements moun had I Dr may Federal statutes and regulations administered by other Federal agencies. or the or any I ouchar the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting treporting or nequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

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,

Signature

Counney 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): K110737

Rightest Blood Glucose Monitoring System GM700 Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 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 1 of 1

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) $\frac{<(1073]}{}$

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.