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

Device Description

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

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study design, which focuses on demonstrating substantial equivalence to a predicate device and strong correlation with a lab reference method (YSI 2300D). The performance is presented through linear regression statistics (slope, intercept, and correlation coefficient 'r').

Acceptance Criteria (Implied)	Device Performance (Rightest BGMS) - Technician Study	Device Performance (Rightest BGMS) - Patient Study
Strong linear correlation with YSI-Plasma reference method:
Slope close to 1.00	Fingerstick: 0.99	Fingerstick: 1.03
	Palmstick: 1.01	Palmstick: 1.02
	Armstick: 0.99	Armstick: 1.02
Intercept close to 0	Fingerstick: 2.51	Fingerstick: -0.25
	Palmstick: 1.70	Palmstick: 1.19
	Armstick: 2.21	Armstick: -0.84
High correlation coefficient (r) (e.g., > 0.98 or similar)	Fingerstick: 0.9901	Fingerstick: 0.9911
	Palmstick: 0.9910	Palmstick: 0.9912
	Armstick: 0.9882	Armstick: 0.9906
Suitability for alternative site testing (finger, palm, arm)	Demonstrated by similar slopes and intercepts across sites for both technician and patient studies.	Demonstrated by similar slopes and intercepts across sites for both technician and patient studies.

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

Test Set Sample Size:
- Technician Study:
  - Fingerstick: 176
  - Palmstick: 176
  - Armstick: 174
- Patient Study:
  - Fingerstick: 176
  - Palmstick: 175
  - Armstick: 174
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective, as it describes a clinical evaluation designed to test the device's performance.

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

The ground truth was established by the YSI 2300D laboratory reference method, not by human experts in a subjective sense. Therefore, the concept of "number of experts" and their "qualifications" doesn't directly apply in the way it would for image-based diagnostics. The YSI 2300D is an automated analyzer, representing an objective standard.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison is directly between the Rightest BGMS readings and the YSI 2300D reference values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. The Rightest Blood Glucose Monitoring System is a quantitative measurement device, not an interpretive one.

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

Yes, the clinical study essentially constitutes a standalone performance evaluation. The "Rightest" device's readings are directly compared to the reference standard (YSI-Plasma) without human intervention in the interpretation of the device's output. The "human-in-the-loop" aspect for a blood glucose meter is the patient or healthcare professional using the device and acting on its numerical output, not interpreting a complex AI output.

7. The Type of Ground Truth Used

The ground truth used was an objective laboratory reference method: YSI 2300D (YSI-Plasma). This is considered a highly accurate and precise standard for measuring blood glucose.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or its sample size. This suggests that the device, being a chemical/enzymatic sensor system, likely relies on established electrochemical principles and calibration procedures rather than a machine learning model that requires a distinct training phase with labeled data in the way AI algorithms often do. Its development likely involved extensive bench testing and calibration rather than a "training set" as understood in contexts like deep learning.

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

As a training set is not explicitly mentioned or implied for a machine learning model, the method for establishing its ground truth is not applicable from the provided text. The device's calibration and accuracy would be verified against reference standards during its development and manufacturing, which is distinct from "ground truth" for an AI training set.

Summary

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FEB ( v ZUOZ

K062567

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:

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: December 18, 2006

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

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

4. Device Description:

1. Intended Use:
  The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.

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

Exhibit 1

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Predicate Device Information: 6.

1 1 1 1

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

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

Comparison to Predicate Devices: 7.

Similarities
Item	DeviceRightest BGMS(Alternative Site Testing)	PredicateRightest BGMS
Detection method	Amperometry	Amperometry
Enzyme	Glucose Oxidase(Aspergillus niger)	Glucose Oxidase(Aspergillus niger)
Mediator	Potassium ferricyanide	Potassium ferricyanide
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
Power	1.5V×2 battery (LR03)	1.5V×2 battery (LR03)
Test range	20 - 600 mg/dL	20 - 600 mg/dL
Differences
Item	Device(Alternative SiteTesting)	Predicate
	Rightest BGMS (AST)	Rightest BGMS
Sample Source	The glucose concentrationis measured withquantitative capillary wholeblood from the fingertip,palm and forearm by usingRightest Blood GlucoseMonitoring System.	The glucose concentrationis measured withquantitative capillary wholeblood from the fingertip,palm and forearm by usingRightest Blood GlucoseMonitoring System.
Description andLabelling	We mention the informationabout modification in user's	We mention the informationin user's manual.

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	manual. We also show adiagrammatic explanationabout alternative test sites inuser's manual.
Test Time	8 seconds	15 seconds
Sample Volume	1.4 uL	2 uL
Memorycapability	1, 7, 14, 30 day average andlast 300 tests in the memory	3, 7, 14 day average and last200 tests in the memory
Battery life	Running 1,000 test	Running 1,500 test
The unit ofmeasurement data	Fix on mg/dL	Switch between mg/dL and mmol/L

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 performance, functionality and reliability of The Rightest Blood Glucose Monitoring System.

The evaluation included with precision, linearity, interference, hematocrit and control solution.

9. Discussion of Clinical Tests Performed:

The clinical test was designed in Alternative site testing study as below

Test capillary blood bv technician Study:

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

Technician	Rightest fingerstick vsYSI-Plasma	Rightest palmstick vsYSI-Plasma	Rightest armstick vsYSI-Plasma
Test range		30 ~ 572
Test number	176	176	174
Slope	0.99	1.01	0.99
Intercept	2.51	1.70	2.21
r	0.9901	0.9910	0.9882

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

Patient	Rightest fingerstick vsYSI-Plasma	Rightest palmstick vsYSI-Plasma	Rightest armstick vsYSI-Plasma
Test range		30-572
Test number	176	175	174

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Slope	1.03	1.02	1.02
Intercept	-0.25	1.19	-0.84
1	0.9911	0.9912------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	0.9906

The "Alternative Site Test" clinical evaluation shows substantial equivalence 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.

Conclusions: 10.

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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is written around the border.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk MDI Consultant, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021

FEB 1 6 2007

Re: K062567

Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: February 2, 2007 Received: February 5, 2007

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean m. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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

K062567 510(k) Number (if known):_

Rightest Blood Glucose Monitoring System Device Name:

Indications For Use:

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

Prescription Use × AND/OR (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)

Z-ON

in Vitro Diagnostic D
and Safet

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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.