The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.

Device Description

The OK Meter Blood Glucose Monitoring System based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. The OK Meter Blood Glucose Monitoring System only needs a 0.7 ul small amount of blood. Capillary action both side near the end of the test strip that draws the blood into the action chamber and the blood glucose result is precisely and displayed in 6 seconds.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

The provided documents describe the "OK Meter Blood Glucose Monitoring System" and its 510(k) submission. However, the document is notably lacking detailed information regarding specific acceptance criteria and the results of a study designed to explicitly prove the device meets those criteria. The information provided focuses on general claims of substantial equivalence to a predicate device and a brief description of the device's technology.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics (e.g., accuracy percentages, precision data, agreement rates, etc.). It generally states that "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." However, the actual data or the acceptance thresholds are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. For blood glucose meters, the "ground truth" would typically refer to results from a laboratory reference method, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used when human interpretation is involved in establishing ground truth for subjective outcomes (e.g., radiology reads). For a blood glucose meter, the reference method provides a direct, objective measurement.

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

This is not applicable. The device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size" of AI assistance.

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

Yes, the device operates as a standalone system. The text states: "The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use)." This directly implies standalone performance by the device itself to produce a quantitative measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the "type of ground truth used," but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., a YSI analyzer), known for their high accuracy and precision, against which the device's measurements are compared.

8. The sample size for the training set

This information is not provided in the given text. For a device based on an electrochemical biosensor, the "training set" might refer to data used for calibrating the sensor and developing the algorithm that converts electrochemical signals into glucose concentrations.

9. How the ground truth for the training set was established

This information is not provided in the given text. Similar to the test set, the ground truth for any calibration or development data would typically be established using highly accurate laboratory reference methods.

Summary of what is available and what is missing:

The document serves as a 510(k) summary, which is typically a high-level overview. While it states that pre-clinical and clinical data were submitted, it does not disclose the detailed results of those studies, the specific acceptance criteria for performance, sample sizes, or the methodology for establishing ground truth beyond the general mention of following FDA guidance for IVD test systems. The primary claim of "substantial equivalence" is made based on shared working principles and technologies with the predicate device, implying that if the predicate device met performance standards, then the OK Meter, by being substantially equivalent, would also be expected to meet similar standards.

To obtain the detailed information requested, one would need to review the full 510(k) submission (K063026) which would contain the detailed study reports and data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the word "Biotech" in a stylized font. Above the word "Biotech" is a circular design with lines and curves. Below the word "Biotech" are Chinese characters. The logo appears to be for a company or organization related to biotechnology.

TEL 886-3-5160258 FAX 886-3-5160028 TEL 86-791-3899362 FAX : 86-791-3880131 http www.okbrotech.com E-mail service dokbictech com

K063026

510(K) Summary of Safety and Effectiveness II. (Per 21 CFR 807.92) 2.1. General Information Establishment FEB 9 2007 트 Manufacturer: OK Biotech Co., Ltd. 1F, No.87, Sec. 2, Gongdao 5th Road. Hsinchu City, Taiwan. 30070 트 Address: 트 Registration Number: 3005862821 를 Contact Person: Dr. Jen, Ke-Min Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax) . Date Prepared: September 25, 2006 Device . Proprietary Name: OK Meter Blood Glucose Monitoring System ● Common Name: Blood Glucose Monitoring System ● Classification Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II,

2.2. Safety and Effectiveness Information

. Predicate Device:
Claim of Substantial Equivalence (SE) is made to ROCHE DIAGNOSTICS CORP. -- Accu-Chek Active Test System (K012324)
. Device Description: The OK Meter Blood Glucose Monitoring System based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. The OK Meter Blood Glucose Monitoring System only needs a 0.7 ul small amount of blood. Capillary action both side near the end of the test strip that draws the blood into the action chamber and the blood glucose result is precisely and displayed in 6 seconds.
3

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with the letters "KR" stacked on top of each other. To the right of the letters is the word "Biotech" in a stylized font. Below the logo is a line of text in Chinese characters. The logo appears to be for a company or organization in the biotechnology field.

TEL : 886-3-5160258 FAX : 886-3-5160028 TEL 86-791-3899362 FAX : 86-791-3880131

Intended Use: .

The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the Testing is done outside the body ( in vitro diagnostic use). It is finger. indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

. Synopsis of Test Methods and Results

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.

. Substantial Equivalence (SE)

A claim of substantial equivalence is made to ROCHE DIAGNOSTICS CORP. -- Accu-Chek Active Test System (K012324). Both of them have the same working principle and technologies. The differences are electric voltage, dimensions of the unit and strip, weight. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.

Ke-Miz-Ter

Ke-Min Jen, Dr. Official Correspondent for OK Biotech Co., Ltd.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ke-Min Jen OK Biotech Co., Ltd. No. 58, Fu Chiun Street Hsin Chu City, 30067 Taiwan, R.O.C.

9 2007 FF

K063026 Re: Trade/Device Name: OK Meter 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 27, 2007 Received: January 30, 2007

Dear Dr. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

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

{4}------------------------------------------------

Indications for Use

K063026 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: OK Meter Blood Glucose Monitoring System

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(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)

AC H
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(KK) 06 3026

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.