The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples. Special condition for use statement(s): Rightest System provides plasma equivalent results.

Device Description

Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets. Rightest meter, Blood Glucose Test Strips, Code Key and Check key 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 Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Rightest Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the clinical study. Instead, it aims to demonstrate "substantial equivalence" to a predicate device and suitability for alternative site testing. The metrics reported are slopes, intercepts, and correlation coefficients (r) from linear regressions comparing the device readings to a reference method (YSI-Plasma). The implicit acceptance criteria are that these statistical measures should be sufficiently close to ideal values (slope of 1, intercept of 0, r close to 1) to establish substantial equivalence.

Metric (Implicit Acceptance Criteria)	Rightest Fingerstick vs YSI-Plasma (Technician)	Rightest Palmstick vs YSI-Plasma (Technician)	Rightest Armstick vs YSI-Plasma (Technician)	Rightest Fingerstick vs YSI-Plasma (Patient)	Rightest Palmstick vs YSI-Plasma (Patient)	Rightest Armstick vs YSI-Plasma (Patient)
Slope (Ideally 1)	1.03	1.02	0.96	1.06	1.03	0.99
Intercept (Ideally 0)	-1.63	1.18	6.55	Not Available*	Not Available*	Not Available*
r (Correlation) (Ideally 1)	0.9852	0.9862	0.9793	Not Available*	Not Available*	Not Available*
Testing Range	55.7 - 490 mg/dL	55.7 - 490 mg/dL	55.7 - 490 mg/dL	55.7 - 490 mg/dL	55.7 - 490 mg/dL	55.7 - 490 mg/dL
Test Number (Sample Size)	134	134	132	134	133	132

*Note: The table for the patient study is truncated in the provided text, only showing slope and test numbers. Intercept and 'r' values are not explicitly stated for the patient study in the snippet provided. Assuming the "not available" cells would be populated if the full table was present.

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

Sample Size (Technician Study):
- Fingerstick: 134
- Palmstick: 134
- Armstick: 132
Sample Size (Patient Study):
- Fingerstick: 134
- Palmstick: 133
- Armstick: 132
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a device manufactured in Taiwan, it's plausible the study was conducted in Taiwan, but this is not confirmed. Clinical tests are generally prospective; however, this is not explicitly stated.

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

The concept of "experts" to establish ground truth as typically understood in AI/imaging studies (e.g., radiologists interpreting images) is not directly applicable here. For blood glucose monitoring systems, the "ground truth" or reference method is typically an established laboratory analyzer.

Reference Method for Ground Truth: YSI 2300D (This is a commonly recognized laboratory glucose analyzer, which serves as the gold standard for comparison).
Qualifications of "Experts": The document mentions "technician" for one part of the study. These would be laboratory technicians trained to operate the YSI 2300D and collect blood samples accurately. No specific number or qualification (e.g., years of experience) is provided for these technicians, as this is standard practice for such laboratory work. For the patient study, patients themselves performed the tests without "experts" determining their glucose level.

4. Adjudication Method for the Test Set:

Not applicable in the context of a blood glucose monitoring system validation study. The "ground truth" is provided by a single, highly accurate laboratory instrument (YSI 2300D), not by multiple human adjudicators reviewing conflicting interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation tasks, not for quantitative measurement devices like a blood glucose meter. The study focuses on the device's accuracy against a gold standard and its performance across different sample sites and user types (technician vs. patient).

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

Yes, the described studies essentially evaluate the standalone performance of the Rightest Blood Glucose Monitoring System. The device's readings are directly compared to the YSI reference method. While a human uses the device, the focus is on the accuracy of the device's measurement, not on how a human's overall decision-making improves with or without using the device's output. The "algorithm" here is the device's internal measurement process.

7. The Type of Ground Truth Used:

The ground truth used was comparative analysis against a well-established laboratory reference method (YSI 2300D). This is a form of highly accurate quantitative measurement from plasma, serving as the gold standard for glucose levels.

8. The Sample Size for the Training Set:

The document does not explicitly mention separate "training" and "test" sets in the context of machine learning model development. This is a medical device validation study, not an AI model development study. The provided data (132-134 tests per arm) represents the clinical validation data set used to demonstrate performance. The device itself (the glucose meter) is likely calibrated during manufacturing based on internal standards and development data, but this "training set" information is not included in this 510(k) summary.

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

As mentioned above, information regarding a "training set" for an AI algorithm is not applicable here. For the calibration and development of the glucose meter itself, the ground truth would typically be established using:

Reference solutions: Solutions with precisely known glucose concentrations.
Laboratory reference methods: Similar to the YSI method used in the validation study, but applied during the device's development and calibration phases.
Statistical process control: To ensure consistency and accuracy during manufacturing.

This information, however, is part of the device's design and manufacturing process and is not detailed in this specific 510(k) summary, which focuses on clinical validation for market clearance.

Summary

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FEB 2 1 2006

Exhibit 1

510(K) SUMMARY

This summary of 510(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: K053635 .

1. Submitter's Identification:

BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Patrick Hsieh Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: February 2, 2006

Name of the Device: Rightest Blood Glucose Monitoring System 2.
Common or Usual Name: Glucose test system 3. Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-The-Counter. Classification: Class II

4. Device Description:

Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets.

Rightest meter, Blood Glucose Test Strips, Code Key and Check key 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 Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

1. Intended Use:
  The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples. Special condition for use statement(s): Rightest System provides plasma equivalent results.
Predicate Device Information: 6.

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

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

7. Comparison to Predicate Devices:

Similarities
Item	DeviceRightest(Alternative SiteTesting)	PredicateRightest
Detection method	Amperometry	Amperometry
Enzyme	Glucose Oxidase(Aspergillus niger)	Glucose Oxidase(Aspergillus niger)
Mediator	Potassium ferricyanide	Potassium ferricyanide
Test range	20 - 600 mg/dL	20 - 600 mg/dL
HematocritRange	30 - 55%	30 - 55%
Temperaturerange	50 - 104° F10 - 40° C	50 - 104° F10 - 40° C
Humidity range	10 - 90%	10 - 90%
Warranty(meter)	3 years	3 years
Open use time(strip)	3 months	3 months
Electrode	Noble metal electrode	Noble metal electrode
Coding	Code key	Code key
Test Time	15 seconds	15 seconds
Sample Volume	2 uL	2 uL
Memorycapability	3, 7, 14 day average and last200 tests in the memory	3, 7, 14 day average and last200 tests in the memory
Power	1.5V×2 battery (LR03)	1.5V×2 battery (LR03)
Battery life	Running 1,500 test	Running 1.500 test
Differences
Item	Device(Alternative SiteTesting)	Predicate
	Rightest	Rightest
Sample Source	The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip, palm and	The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip by using

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forearm by using RightestBlood GlucoseMonitoring System.	Rightest Blood GlucoseMonitoring System.
Description andLabelling	We mention theinformation aboutalternative site testing inuser's manual and packingbox. We also show adiagrammatic explanationabout alternative test sitesin user's manual.	We mention theinformation in user'smanual.

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 with precision, linearity, interference, environment factors (ex. Temperature, humidity and altitude), hematocrit and control solution.

9. Discussion of Clinical Tests Performed: The clinical test was designed in Alternative site testing study as below

The clinical test was designed in Alternative site testing study as

Test capillary blood by technician Study:

It shows similarly slope and intercept for difference position of capillary blood test by technician.

Technician	Rightest fingerstickvs YSI-Plasma	Rightest palmstickvs YSI-Plasma	Rightest armstickvs YSI-Plasma
Testing range	55.7~490 mg/dL	55.7~490 mg/dL	55.7~490 mg/dL
Test number	134	134	132
Slope	1.03	1.02	0.96
Intercept	-1.63	1.18	6.55
r	0.9852	0.9862	0.9793

Fig 1 Linear regression from Rightest versus YSI 2300D

Test capillary blood by patient Study:

It shows similarly slope and intercept of difference positions of capillary blood test by Patient.

Fig 2 Linear regression from Rightest versus YSI 2300D

Technician	Rightest fingerstickvs YSI-Plasma	Rightest palmstickvs YSI-Plasma	Rightest armstickvs YSI-Plasma
Testing range		55.7 ~ 490 mg/dL
Test number	134	133	132
Slope	1.06	1.03	0.99

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The "Alternative Site Test" clinical evaluation shows substantially equivalent to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus YSI 2300D. So the result tells us Rightest blood glucose monitoring system is suitable to be used in finger, palm and arm.

10. Conclusions:

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System (Alternative Site Testing) testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System. The precision and accuracy of Rightest 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

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "U.S. Department of Health & Human Services - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 1 2006

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk MDI Consultant, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11201

Re: K053635

Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR§ 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW. CGA Dated: December 28, 2005 Received: December 29, 2005

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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, 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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Indications for Use

510(k) Number (if known): K053635

Device Name: Rightest Blood Glucose Monitoring System

Indications For Use:

This device is not intended for testing neonate blood samples.

Special condition for use statement(s): Rightest System provides plasma equivalent results.

Prescription Use X (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)

Ann Chappie

Division Sign-Off

Device I

Page 1 of

510(k)

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.