(130 days)
No
The description focuses on electrochemical biosensor technology and capillary action for glucose measurement, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition or performing a therapeutic intervention on a patient.
Yes
Explanation: The device is intended for the quantitative measurement of glucose in blood, which is used as an aid to monitoring levels in Diabetes Mellitus, clearly fitting the definition of a diagnostic device.
No
The device description explicitly mentions electrochemical biosensor technology, capillary action, and test strips, all of which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Testing is done outside the body ( in vitro diagnostic use)."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW, CGA, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
Not for use on neonates.
Intended User / Care Setting
lay uses by people with diabetes and in a clinical setting by health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ROCHE DIAGNOSTICS CORP. -- Accu-Chek Active Test System (K012324)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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.
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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.
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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).
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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
K063026 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: OK Meter Blood Glucose Monitoring System
Indications for Use:
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.
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
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Office of In Vitro Diagnostic Device
Evaluation and Safety
510(KK) 06 3026