The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.

This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.

Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.

Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 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.

Device Description

Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Rightest Blood Glucose Monitoring System, Model GM550, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses performance criteria commonly accepted for blood glucose monitoring systems, specifically focusing on agreement with a laboratory reference method. The acceptance criteria and reported performance are grouped by glucose concentration ranges.

Glucose Concentration Range	Acceptance Criteria (Implicit)	Reported Device Performance (Fingertip, Palm, Forearm)
< 75 mg/dL	97% of results within ± 15 mg/dL of comparison method	Fingertip: - Within ± 5 mg/dL: 78.9% (15/19) - Within ± 10 mg/dL: 100% (19/19) - Within ± 15 mg/dL: 100% (19/19) Palm: - Within ± 5 mg/dL: 78.9% (15/19) - Within ± 10 mg/dL: 94.7% (18/19) - Within ± 15 mg/dL: 100% (19/19) Forearm: - Within ± 5 mg/dL: 42.1% (8/19) - Within ± 10 mg/dL: 78.9% (15/19) - Within ± 15 mg/dL: 94.7% (18/19) Overall for all sites: 97% of test results were within ± 15 mg/dL (as per the summary description for alternative site testing).
≥ 75 mg/dL	97% of results within ± 20% of comparison method	Fingertip: - Within ± 5%: 55.8% (53/95) - Within ± 10%: 75.8% (72/95) - Within ± 15%: 91.6% (87/95) - Within ± 20%: 96.8% (92/95) Palm: - Within ± 5%: 55.8% (53/95) - Within ± 10%: 75.8% (72/95) - Within ± 15%: 89.5% (85/95) - Within ± 20%: 96.8% (92/95) Forearm: - Within ± 5%: 49.5% (47/95) - Within ± 10%: 71.6% (68/95) - Within ± 15%: 91.6% (87/95) - Within ± 20%: 97.9% (93/95) Overall for all sites: 97% of test results were within ± 20% (as per the summary description for alternative site testing).

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

Sample Size: A total of 114 patients participated in the system accuracy study.
- For glucose concentrations < 75 mg/dL, there were 19 samples.
- For glucose concentrations ≥ 75 mg/dL, there were 95 samples.
Data Provenance: The document does not explicitly state the country of origin. The submitter's identification lists BIONIME CORPORATION in Taichung County, TAIWAN, which suggests the study was likely conducted in Taiwan. The study was prospective in nature, as patients collected and tested their own blood samples for the study.

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

The ground truth was established by a laboratory instrument, not by human experts. The reference method used was the Olympus 2700, which is a lab instrument.
The document does not specify any number of experts or their qualifications for establishing ground truth, as an automated instrument was used.

4. Adjudication Method for the Test Set:

There was no explicit adjudication method described. The comparison was directly between the Rightest meter's reading and the result from the Olympus 2700 lab instrument.

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:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a blood glucose monitor, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of typical MRMC studies. The "User Performance Study" was to demonstrate lay consumers could obtain accurate results, focusing on usability rather than reader improvement with AI assistance.

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

Yes, the system accuracy study evaluated the device's performance (Rightest meter with test strips) in a standalone manner by comparing its readings directly against a laboratory reference instrument (Olympus 2700). The user performance study involved human users, but the "standalone performance" of the device itself (measurement accuracy) was assessed against the lab reference.

7. The Type of Ground Truth Used:

The ground truth used was laboratory instrument reference values (plasma glucose values on an Olympus 2700 lab instrument).

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" or its sample size. For medical devices like blood glucose monitors, analytical performance studies (like linearity, precision, interference) and clinical accuracy studies are conducted, rather than machine learning-style training and test sets in the typical sense. The 114 patients and their samples described in the "System Accuracy Study" would represent the clinical validation data, not a training set.

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

As a training set is not explicitly referred to in the context of this device's validation, the method for establishing its ground truth is not applicable or detailed. The ground truth for the clinical validation was established by the Olympus 2700 lab instrument.

Summary

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JUN 1 8 2010

Exhibit 1

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: K09205 J

1. Submitter's Identification:
  BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. George Chi Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: June 01, 2010

2. Name of the Device: Rightest Blood Glucose Monitoring System, Model GM550

1. Common or Usual Name: Glucose test system Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter. Classification: Class II

Device Description: 4.

ട. Intended Use:
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.

The alucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring

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System, GM550. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.

Rightest GS550 Blood Glucose Test Strips are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, and forearm.

Rightest Control Solutions are intended for use with the Rightest GM550 Blood Glucose meter 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.

. Predicate Device Information:

The Rightest Blood Glucose Monitoring System GM550 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.

Name:	Rightest Blood Glucose Monitoring System
Device Company:	Bionime Corporation
510(K) Number:	K042678, K053635 and K062567

Comparison to Predicate Devices: 7.

Specification	Rightest BGMS GM550	Rightest BGMS GM300
	(New Device)	(Predicate Device-K062567)
Interference	Uric acid $\geq$ 10 mg/dL	Uric acid > 9.0 mg/dL
Memory Capacity	500 blood glucose test resultswith date and time	300 blood glucose test results withdate and time
Power Supply	Two CR2032 batteries	Two 1.5V (AAA) batteries
Power Saving	Turn off automatically 2 minutesafter last user action / Press themain button for 4 seconds.	Turn off automatically after 3minutes no use
Meter Dimension	90.6 mm × 46 mm × 16.5 mm	85.0 mm × 58.0 mm × 22.0 mm
Meter Weight	53.0 ± 5 g with batteries	85.0 g with batteries
Coding	Auto coding	Code key
Minimum Sample Volume	1.0 microliter	1.4 microliter
Test Time	5 seconds	8 seconds
Hematocrit Range	30 - 60%	30 - 55%
LCD display area	47 mm × 33.5 mm	39.0 mm × 38.0 mm
Strip Reagent	1.Glucose Oxidase (GOD) 14.8%2.Potassium ferricyanide 39.5%3.Non-reactive ingredients 45.7%	1.Glucose Oxidase (GOD) 8.5%2.Potassium ferricyanide 48.5%3.Non-reactive ingredients 43%
Control Solution Reagent(Normal level)	1.Water 84%2.d-Glucose 0.1%3.Viscosity enhancing agent 15%4.Inorganic salts / Buffers 1.0%5.Dye 0.08%6.Preservative 0.03%	1.Water 83%2.d-Glucose 0.1%3.Viscosity enhancing agent 15%4.Inorganic salts / Buffers 1.4%5.Dye 0.005%6.Preservative 0.03%
Control Solution Reagent(High level)	1.Water 69%2.d-Glucose 0.3%3.Viscosity enhancing agent 29.5%4.Inorganic salts / Buffers 1.0%5.Dye 0.08%6.Preservative 0.03%	1.Water 83%2.d-Glucose 0.3%3.Viscosity enhancing agent 15%4.Inorganic salts / Buffers 1.4%5.Dye 0.005%6.Preservative 0.03%
Measurement Technology	Oxidase Electrochemical Sensor
Sample	Capillary whole blood
Measuring Range	20-600 mg/dL
Operating TempatureRange	10 ~ 40°C (50 ~ 104 °F)
Operating Relative HumidityRange	10 ~ 90%
Battery Life	About 1000 tests
Meter Storage Conditions	-10 ~ 60°C (14 ~ 140 °F)
Test Strip StorageConditions	4 ~ 30°C (39 ~ 86 °F), < 90% relative humidity
The unit of measurementdata	Fix on mg/dL

Specification Comparison

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8. 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: ഗ്

System Accuracy Study:

For the alternative site:

The accuracy of the alternative site test study of the Rightest™ Blood Glucose Monitoring System was proved by comparing whole blood (plasma equivalent) glucose values on the Rightest™ meter with plasma qlucose values on a lab instrument.

A total of 114 patients participated. Each patient collected and tested their own blood samples (from the fingertip, palm and forearm) with the Rightest™ meter. Another blood sample was collected within 5 minutes and got the plasma to be analyzed by the lab instrument. Ninety-seven percent of the test results were within ± 20% of the comparison method results at glucose concentrations ≥75 mg/dL and within ±15 mg/dL at glucose concentrations < 75 mg/dL.

The Results and differences between the two methods, the Rightest Blood Glucose Monitoring System and the Olympus 2700 (Lab instrument used as the reference method) are demonstrated in the tables below.

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 capillary whole blood from fingertip, palm, forearm, and upper arm sample sites.

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Table 1: represents samples for glucose results lower than 75 mg/dL.

	The percent ( and number ) of samples for which the difference
Difference range in valuesbetween the Olympus valueand the Rightest meter value	between the Rightest meter value ( Alternative site ) and theOlympus value were within the difference range shown in theside row.
	Fingertip	Palm	Forearm
Within ± 5 mg/dL	78.9% (15/19)	78.9% (15/19)	42.1% (8/19)
Within ± 10 mg/dL	100% (19/19)	94.7% (18/19)	78.9% (15/19)
Within ± 15 mg/dL	100% (19/19)	100% (19/19)	94.7% (18/19)

Table 2: represents samples for glucose results greater than 75 mg/dL.

	The percent ( and number ) of samples for which the difference
Difference range in values	between the Rightest meter value ( Alternative site ) and the
between the Olympus value	(Olympus value were within the difference range shown in the
and the Rightest meter value	side row.
	Fingertip	Palm	Forearm
Within ± 5%	55.8% (53/95)	55.8% (53/95)	49.5% (47/95)
Within ± 10%	75.8% (72/95)	75.8% (72/95)	71.6% (68/95)
Within ± 15%	91.6% (87/95)	89.5% (85/95)	91.6% (87/95)
Within ± 20%	96.8% (92/95)	96.8% (92/95)	97.9% (93/95)

The "Alternative Site Test" clinical evaluation shows substantial equivalence to Rightest Blood Glucose Monitoring System used in fingertip, palm and forearm position. So the result tells us Rightest blood glucose monitoring system GM550 is suitable to be used in fingertip, palm and forearm.

Conclusions: 10.

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System GM550 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System GM300 (AST). The precision and accuracy of Rightest Blood Glucose Monitoring System GM550 is suitable for its in monitoring the effectiveness of diabetes management at home and in clinical settings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 18 100

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk Official Correspondent for Bionime Corporation 55 Northern Blvd. Suite 200 Great Neck, New York 11021

K092052 Re:

Trade Name: Rightest Blood Glucose Monitoring System, Model GM550 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 04, 2010 Received: June 07, 2010

Dear Ms. Goldstein-Falk:

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 your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 l edonal agencies: "1 ou and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 11mmod to: registration and 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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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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

C.A.C.

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

Enclosure

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EXHIBIT B

Page 1 of 1

Indications for Use

K092052 510(k) Number (if known):

Device Name: Rightest Blood Glucose Monitoring System, Model GM550

Indications For Use:

This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.

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)

Carol C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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.