The Okmeter Match Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The meter has some audible features but it is not for use by the visually impaired.

The Okmeter Test Surins are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Okmeter Test Strips must be used with the Okmeter Match Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Okmeter 2 levels (Normal and High) Control Solution are for use with the Okmeter Match Blood Glucose Monitoring System and Okmeter Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Match Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds. The device including two test strips there are identical in structure design and test performance, the only difference in colors (White for strip A and Green for strip B).

AI/ML Overview

The provided text lacks specific details about acceptance criteria and the results of a study proving the device meets those criteria. However, I can extract the available information and highlight what is missing based on your request.

Here's a breakdown of the available information and what's not present:

Acceptance Criteria and Device Performance:

The document mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA." This implies that the device was tested against FDA guidance, which would contain specific acceptance criteria for accuracy, precision, and other relevant performance metrics for blood glucose monitoring systems. However, the exact acceptance criteria and the reported numerical performance of the Okmeter Match Blood Glucose Monitoring System are not provided in the given text.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
Accuracy (e.g., within +/- X% of Y reference)	Not provided in the text	Not provided in the text
Precision (e.g., standard deviation)	Not provided in the text	Not provided in the text
Measuring Time	6 seconds (implied as a feature, not a criterion)	6 seconds
Sample Volume	Small amount of blood (implied)	Small amount of blood
Detecting Range	Not provided in the text	Not provided in the text
HCT Range	Not provided in the text	Not provided in the text

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

Test Set Sample Size: Not provided in the text. The document states "Pre-clinical and clinical data are employed," but it does not specify the number of subjects or samples used in these studies.
Data Provenance: The manufacturer is OK Biotech Co., Ltd., located in Taiwan, ROC. The studies were likely conducted in Taiwan, but this is not explicitly stated for the clinical data. The document does not specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by laboratory reference methods, not by expert consensus on image interpretation. Therefore, this question may not be directly applicable in the same way it would be for an AI-powered diagnostic imaging device. If expert validation of a reference method was involved, the details are missing.

4. Adjudication Method for the Test Set:

Not applicable/Not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in subjective assessments (e.g., expert interpretation of medical images). For a quantitative device like a blood glucose meter, the "ground truth" is typically a quantitative measurement from a highly accurate lab instrument, not subject to individual interpretation or adjudication among experts in this manner.

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

Not applicable/Not provided in the text. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Okmeter Match Blood Glucose Monitoring System is a standalone device for direct quantitative measurement, not an AI-assisted diagnostic tool that helps human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, by definition. The Okmeter Match Blood Glucose Monitoring System is a standalone device. Its performance, as implied by the "Pre-clinical and clinical data," would represent its standalone accuracy and precision. The reported "6 seconds" for result display is a standalone performance metric.

7. The Type of Ground Truth Used:

Implied to be laboratory reference methods for glucose measurement. While not explicitly stated, for a blood glucose monitoring system, the ground truth is universally established by a highly accurate, often laboratory-based, glucose analyzer. The document mentions "Pre-clinical and clinical data," which would have involved comparing the device's readings to such a reference method. The text does not mention pathology, outcomes data, or expert consensus in this context.

8. The Sample Size for the Training Set:

Not applicable/Not provided in the text explicitly as a "training set." Blood glucose meters based on electrochemical biosensor technology generally do not involve AI/machine learning training sets in the same way an image recognition algorithm would. While there is likely internal verification and calibration during development, the document doesn't describe a distinct "training set" with established ground truth as would be relevant for an AI model.

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

Not applicable/Not provided in the text. See the explanation for point 8.

Summary

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K0906609

Image /page/0/Picture/1 description: The image shows a logo with the text "Kbiotech" in a stylized font. Above the text is a circular graphic with a "K" in the center. Below the text is a line of Chinese characters.

Turwan : TEL : 886-3-5160258 FAX : 886-3-5160028 China : TE1. : 86-791-3899362 FAX : 86-791-3880131

FEB - 4 2010

http://www.okbiotech.com E-mail:service/a okbiotech.com

II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

2.1. General Information Establishment

트 Manufacturer: OK Biotech Co., Ltd.
트 Address: 1F, No. 87, Sec. 2, Gongdaowu Road, Hsin Chu City, 30070, Taiwan. ROC
를 Owner Number: 9090860
를 Contact Person: Dr. Jen. Ke-Min E-mail: ceirs.jen@msa.hinet.net 886-3-5208829 (Tel): 886-3-5209783 (Fax) Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
Date Prepared: February 27, 2009

Device

Proprietary Name: Okmeter Match Blood Glucose Monitoring System ●
. Common Name: Blood Glucose Monitoring System Classification Name: ● SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II � Product Code: NBW

2.2. Safety and Effectiveness Information

. Predicate Device:

Claim of Substantial Equivalence (SE) is made to PRODIGY Voice Blood Glucose Monitoring System (K073118)

. Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Match Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds. The device including two test strips there are identical in structure design and test performance, the only difference in colors (White for strip A and Green for strip B).

● Intended Use:

The Okmeter Match Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the paim, the forearm, the upper-arm. the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative

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Image /page/1/Picture/1 description: The image shows a logo with the text "Kbiotech" in a stylized font. Above the text is a circular graphic design. Below the text is smaller text in a different language, possibly Chinese. The logo appears to be for a company named Kbiotech.

http://www.okbiotech.com E-mail:service wokbiotech.com

site testing in this system can be used only during steady-state blood glucose conditions. The meter has some audible features but it is not for use by the visually impaired.

The Okmeter Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Okmeter Test Strips must be used with the Oknieter Match Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes. or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

● Synopsis of Test Methods and Results

Pre-clinical and clinical data are cmployed upon submission of this .510(K) premarket notification according to the Guidance Document for In Viro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/FDA.

● Substantial Equivalence (SE)

A claim of substantial equivalence is made to PRODIGY Voice Blood Glucose Monitoring System (K073118). Both of them have the same working principle and technologies including sample volume, measuring time, detecting range, HCT range, calibration method, voice function, and memory data number. The major differences for the two devices are meter dimension. weight: and the subject has two test strips. Besides, the subject device and predicate device is same intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites; the palm, the forearm, the

upper-arm, the calf and the thigh. Thus the differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent.

Ke Min Tan

Dr. Jen. Ke-Min official correspondent for OK BIOTECH CO., LTD.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB - 4 2010 OK Biotech Co., Ltd. c/o Dr. Ke-Min Jen ROC Chinese-European Indus. Research Society No. 58, Fu Chuin Street Hsin Chu City, China (Taiwan) 30067

Re: K090609

Trade Name: OKmeter Match Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 19, 2010 Received: January 19, 2010

Dear Dr. Ke-Min Jen:

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); medical device reporting (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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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,

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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Indication for Use

510(k) Number (if known): K090609

Device Name: Okmeter Match Blood Glucose Monitoring System

Indication For Use:

Prescription Use _ V (21 CFR Part 801 Subpart D)

Over the Counter Use V (21 CFR Part 801 Subpart C)

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

And / Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K090609

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.