(357 days)
Not Found
No
The description focuses on electrochemical biosensor technology and capillary action, with no mention of AI, ML, or related concepts.
No.
The device is a diagnostic tool used to measure glucose levels, not directly treat a condition.
Yes
The device is described as an "in vitro diagnostic use" system that measures glucose levels as an aid to monitor the effectiveness of diabetes control.
No
The device description explicitly mentions "OKmeter Direct Blood Glucose Meter" and "OKmeter Direct Test Strips," which are hardware components used for the quantitative measurement of glucose. The system relies on electrochemical biosensor technology and capillary action, indicating a physical device is involved in the measurement process.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used for diagnostic purposes outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Direct 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, upper-arm, calf, thigh, or palm.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home, healthcare 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.
For Home Users:
The table below was based on a study done with 135 patients to see how well the OKmeter Direct Blood Glucose Monitoring System compared to the YSI 2300.
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Finger capillary whole blood: Within±5%: 83/114 (73%), Within±10%: 100/114 (88%), Within±15%: 111/114 (97%), Within±20%: 114/114 (100%)
Regression for Finger capillary whole blood: n=135, Slope=0.982, Intercept=1.2484, R2=0.9866
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Palm capillary whole blood: Within±5%: 74/114 (65%), Within±10%: 102/114 (89%), Within±15%: 111/114 (97%), Within±20%: 114/114 (100%)
Regression for Palm capillary whole blood: n=135, Slope=0.9972, Intercept=-0.4212, R2=0.9874
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Forearm capillary whole blood: Within±5%: 64/114 (56%), Within±10%: 99/114 (87%), Within±15%: 113/114 (99%), Within±20%: 114/114 (100%)
Regression for Forearm capillary whole blood: n=135, Slope=0.9778, Intercept=1.6689, R2=0.9817
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Upper arm capillary whole blood: Within±5%: 75/114 (66%), Within±10%: 102/114 (89%), Within±15%: 111/114 (97%), Within±20%: 114/114 (100%)
Regression for Upper arm capillary whole blood: n=135, Slope=1.0089, Intercept=-1.377, R2=0.9805
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Calf capillary whole blood: Within±5%: 66/114 (58%), Within±10%: 98/114 (86%), Within±15%: 112/114 (98%), Within±20%: 114/114 (100%)
Regression for Calf capillary whole blood: n=135, Slope=0.9884, Intercept=1.3662, R2=0.9794
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Thigh capillary whole blood: Within±5%: 72/114 (63%), Within±10%: 96/114 (84%), Within±15%: 110/114 (96%), Within±20%: 114/114 (100%)
Regression for Thigh capillary whole blood: n=135, Slope=1.0191, Intercept=-3.1886, R2=0.986
For Healthcare Professionals:
The table below was based on a study done with 135 patients to see howwell the OKmeter Direct Blood Glucose Monitoring System compared to theYSI 2300.
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Finger capillary whole blood: Within±5%: 84/114 (74%), Within±10%: 100/114 (88%), Within±15%: 111/114 (97%), Within±20%: 114/114 (100%)
Regression for Finger capillary whole blood: n=135, Slope=1.0001, Intercept=-0.6033, R2=0.9884
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Palm capillary whole blood: Within±5%: 77/114 (68%), Within±10%: 99/114 (87%), Within±15%: 110/114 (96%), Within±20%: 114/114 (100%)
Regression for Palm capillary whole blood: n=135, Slope=0.99, Intercept=1.7572, R2=0.9859
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Forearm capillary whole blood: Within±5%: 67/114 (59%), Within±10%: 97/114 (85%), Within±15%: 109/114 (96%), Within±20%: 114/114 (100%)
Regression for Forearm capillary whole blood: n=135, Slope=0.9962, Intercept=-0.9202, R2=0.9843
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Upper arm capillary whole blood: Within±5%: 69/114 (61%), Within±10%: 100/114 (88%), Within±15%: 109/114 (96%), Within±20%: 114/114 (100%)
Regression for Upper arm capillary whole blood: n=135, Slope=1.0111, Intercept=-1.2414, R2=0.9808
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Calf capillary whole blood: Within±5%: 67/114 (59%), Within±10%: 99/114 (87%), Within±15%: 109/114 (96%), Within±20%: 114/114 (100%)
Regression for Calf capillary whole blood: n=135, Slope=0.967, Intercept=3.9017, R2=0.9823
Results for glucose concentration= 75 mg/dL (4.2 mmol/L)
Thigh capillary whole blood: Within±5%: 74/114 (65%), Within±10%: 97/114 (85%), Within±15%: 109/114 (96%), Within±20%: 114/114 (100%)
Regression for Thigh capillary whole blood: n=135, Slope=1.0095, Intercept=-1.1861, R2=0.9856
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Auqust 14, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OK BIOTECH CO., LTD. JEN KE-MIN 1F, NO. 87, SEC. 2, GONGDAOWU ROAD HSIN CHU CITY 30070 TAIWAN
Re: K132633
Trade/Device Name: OKmeter Direct Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: July 17, 2014 Received: July 15, 2014
Dear Dr. Jen. Ke-min:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K132633
Device Name
Okmeter Direct Blood Glucose Monitoring System
Indications for Use (Describe)
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, calf, thigh, or palm.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows a logo with the letter K inside of a circle. Next to the K is the word "biotech" in a bold, sans-serif font. Below the word "biotech" is some text in another language.
5. 510(K) Summary of Safety and Effectiveness
(Per 21 CFR 807.92)
5.1. General Information Establishment
| ■ | The assigned 510(k) number is : | K132633 |
|---|---|---|
| ■ | Manufacturer: | OK Biotech Co., Ltd. |
| ■ | Address: | 1F, No. 87, Sec. 2, Gongdaowu Road, Hsin Chu City, |
| 30070, Taiwan, ROC | ||
| ■ | Owner Number: | 9090860 |
| ■ | 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: | July 26, 2013 |
| Device | ||
| ● | Proprietary Name: | Okmeter Direct Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitoring System |
|---|---|
| ● Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE |
| OVER THE COUNTER, Class II | |
| ● Product Code: | NBW |
5.2. Safety and Effectiveness Information
- Predicate Device: Claim of Substantial Equivalence (SE) is made to Okmeter Match Blood Glucose Monitoring System (K090609)
- Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, Okmeter Direct 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.
● Intended Use:
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
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Image /page/4/Picture/0 description: The image shows a logo with the letter 'K' inside of an oval shape. To the right of the 'K' is the word 'biotech' in bold, sans-serif font. Below the word 'biotech' is a line of text in a different language, possibly Chinese or Japanese.
E-mail:service@okbiotech.com
The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.
● Substantial Equivalence (SE)
A claim of substantial equivalence is made to Okmeter Match Blood Glucose Monitoring System (K090609). Both of them have the same working principle and technologies including sample volume, measuring time, detecting range, HCT range, calibration method, and memory data number. The major differences for the two devices are meter dimension, weight; especially the predicate device using two colors of the test strips and has some audible features but it is not for use by the visually impaired. B 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.
● 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.
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Image /page/5/Picture/0 description: The image shows a logo with the letter K inside of an oval shape. Next to the K is the word "biotech" in bold font. Below the word biotech is a line of Chinese characters.
For Home Users
The table below was based on a study done with 135 patients to see how well the OKmeter Direct Blood Glucose Monitoring System compared to the YSI 2300.
- Finger capillary whole blood
Image /page/5/Figure/6 description: The image is a scatter plot titled "Lay users vs. YSI 2300". The x-axis is labeled "YSI2300 (mg/dL)" and ranges from 0 to 720. The y-axis is labeled "Meter (mg/dL)" and ranges from 0 to 720. The plot shows a positive correlation between the two variables, with a regression equation of y = 0.9820x + 1.2484 and an R-squared value of 0.9866.
Results for glucose concentrationn | Slope | Intercept | R2 |
| 135 | 0.9972 | -0.4212 | 0.9874 |
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Image /page/7/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K enclosed in an oval shape. Below the K is the word "biotech" in a bold, sans-serif font. Underneath the word "biotech" is some Chinese text.
Image /page/7/Figure/3 description: The image is a scatter plot titled "Lay users vs. YSI 2300". The x-axis is labeled "YSI2300 (mg/dL)" and ranges from 0 to 720. The y-axis is labeled "Meter (mg/dL)" and ranges from 0 to 720. The scatter plot shows a positive correlation between the two variables, and the equation of the regression line is y = 0.977x + 1.668 with an R-squared value of 0.981.
- Forearm capillary whole blood 0
Results for glucose concentrationn | Slope | Intercept | R2 |
| 135 | 0.9884 | 1.3662 | 0.9794 |
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Image /page/10/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K enclosed in an oval shape, followed by the text "biotech" in a bold, sans-serif font. Below the English text, there is Chinese text, which is likely the company's name in Chinese characters. The logo is simple and modern, with a focus on the company's name and brand identity.
Image /page/10/Figure/3 description: The image is a scatter plot titled "Lay users vs. YSI 2300". The x-axis is labeled "YSI 2300 (mg/dL)" and ranges from 0 to 720, while the y-axis is labeled "Meter (mg/dL)" and also ranges from 0 to 720. The plot shows a positive correlation between the two variables, with data points clustered around a regression line represented by the equation y = 1.019x - 3.188 and an R-squared value of 0.986.
Thigh capillary whole blood ●
Results for glucose concentrationn | Slope | Intercept | R2 |
| 135 | 1.0191 | -3.1886 | 0.986 |
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Image /page/11/Picture/0 description: The image contains a logo with the letter K inside a circular design. Next to the logo is the word "Kbiotech" in a bold, sans-serif font. Below the word "Kbiotech" is some text in a smaller font size, which appears to be in Chinese. The text is arranged in a horizontal line.
For Healthcare Professionals
The table below was based on a study done with 135 patients to see howwell the OKmeter Direct Blood Glucose Monitoring System compared to theYSI 2300.
- Finger capillary whole blood
Image /page/11/Figure/6 description: This image is a scatter plot comparing a healthcare professional's meter readings to YSI 2300 readings, both measuring in mg/dL. The x-axis represents YSI 2300 readings, while the y-axis represents the meter readings. A regression line is plotted through the data points, with the equation y = 1.000x - 0.603 and an R-squared value of 0.988, indicating a strong positive correlation between the two sets of readings.
Results for glucose concentrationn | Slope | Intercept | R2 |
| 135 | 1.0001 | -0.6033 | 0.9884 |
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Image /page/12/Picture/0 description: The image contains a logo with the letter K inside a circular design. Next to the logo is the word "biotech" in bold, followed by Chinese characters. The logo appears to represent a company or organization in the biotechnology field, with the Chinese characters likely representing the company's name or a related term in Chinese.
- Palm capillary whole blood 0
Image /page/12/Figure/4 description: The image is a scatter plot comparing a healthcare professional's measurements against YSI 2300 measurements. The x-axis represents YSI 2300 in mg/dL, ranging from 0 to 720, while the y-axis represents the meter readings in mg/dL, also ranging from 0 to 720. A regression line is plotted through the data points, with the equation y = 0.99x + 1.757 and an R-squared value of 0.985, indicating a strong positive correlation between the two measurement methods.
Results for glucose concentrationn | Slope | Intercept | R2 |
| 135 | 1.0111 | -1.2414 | 0.9808 |
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Image /page/15/Picture/0 description: The image contains a logo with the letter K inside a circular design. Next to the logo is the word "biotech" in bold, followed by Chinese characters. The logo appears to represent a company or organization in the biotechnology field, with the Chinese characters likely representing the company's name or a related term in Chinese.
- Calf capillary whole blood ●
Image /page/15/Figure/4 description: The image is a scatter plot comparing two different methods of measuring glucose levels: a healthcare professional's meter and a YSI 2300 analyzer. The x-axis represents the glucose levels measured by the YSI 2300 in mg/dL, while the y-axis represents the glucose levels measured by the healthcare professional's meter in mg/dL. The scatter plot shows a strong positive correlation between the two methods, with most of the data points clustered around a regression line. The regression equation is y = 0.967x + 3.901, and the R-squared value is 0.982, indicating a good fit of the regression line to the data.
Results for glucose concentration