(72 days)
Not Found
No
The description focuses on standard blood glucose monitoring technology with a speaking function for accessibility, and there are no mentions of AI, ML, or related concepts.
No.
The device is a diagnostic tool for monitoring blood glucose levels, not a device that directly treats or prevents a disease.
No
Justification: The "Intended Use / Indications for Use" explicitly states, "It is not intended for the diagnosis or screening for diabetes mellitus..." indicating it is not a diagnostic device.
No
The device description explicitly lists hardware components such as a blood glucose meter, test strips, control solutions, and a lancing device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The device consists of a blood glucose meter, test strips, and control solutions, all components typical of an IVD system used for analyzing biological samples.
- Function: The core function is to measure a substance (glucose) in a biological fluid (blood) to aid in monitoring a medical condition (diabetes).
The definition of an IVD generally includes devices intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description for monitoring diabetes.
N/A
Intended Use / Indications for Use
The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
Product codes
NBW, CGA
Device Description
The Easy Talk Blood Glucose Monitoring System, consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger and the forearm
Indicated Patient Age Range
Not intended for use with neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
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
Non-clinical Tests: Biotest Medical Corp. has performed the extensive verification, validation and testing activities to establish the performance, functionality and reliability characteristics of the device. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Clinical Tests: The clinical performance study was conducted for purpose of validating consumer's use of the Easy Talk Blood Glucose Monitoring System in term of usability and accuracy. The test results showed substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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.
0
Kivosto O
MAY 1 2 2010
510(k) Summary (Per 21 CFR 807.92)
Updated on April 6, 2010
1. Submitter Information
| Company name | Biotest Medical Corporation |
|---|---|
| Contact person | Maggie Chu, President |
| Address | No. 3-2, Chien-Kuo Road, TEPZ, Tantzu |
| Taichung 427, Taiwan | |
| Republic of China | |
| Phone | 886-919099431 |
| Fax | 886-425326593 |
2. Name of Device
| Trade Name | Easy Talk Blood Glucose Monitoring System |
|---|---|
| Common Name | Blood Glucose Test System |
| Classifications | NBW, Over the Counter Blood Glucose Test, 862.1345 |
| CGA, Glucose Oxidase, 862.1345 | |
| Class II device |
3. Predicate Device
| Trade name | SuperCheck 1 Blood Glucose Monitoring System (SuperCheck 1)
Model 6268 |
|---------------|---------------------------------------------------------------------------|
| Common name | Blood Glucose Test System |
| Submitter | Biotest Medical Corporation |
| 510(k) number | K091815 |
4. Device Description
The Easy Talk Blood Glucose Monitoring System, consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
5. Intended Use
The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
1
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
6. Comparison to Predicate Device
Modifications to the cleared device include additional backlight feature and change of one error message from E 7 to E 4. The size and shape of the device have also been modified to differentiate from the predicate. The Easy Talk Blood Glucose Monitoring System has the same indented use and fundamental scientific technology as the previous version, the SuperCheck 1 Blood Glucose Monitoring System, Model 6268.
7. Performance Studies
Non-clinical Tests
Biotest Medical Corp. has performed the extensive verification, validation and testing activities to establish the performance, functionality and reliability characteristics of the device. The device passed all of the tests based on pre-determined Pass/Fail criteria:
Clinical Tests
The clinical performance study was conducted for purpose of validating consumer's use of the Easy Talk Blood Glucose Monitoring System in term of usability and accuracy? The test results showed substantial equivalence.
8. Conclusion
The conclusion drawn from the non-clinical and clinical tests is that the Easy Talk Blood Glucose Monitoring System is as safe, as effective, and performs as well as the legally marketed predicate device, SuperCheck 1 Blood Glucose Monitoring System, model 6268 (K091815). Therefore, the subject device is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAY 1.2 2010
Biotest Medical Corporation c/o Maggie Chu President No. 3-2, Chien-Kuo Road, TEPZ, Tantzu Taichung, China (Taiwan) 427
Re: K100560 Trade/Device Name: Easy Talk Blood Glucose Monitoring System, Model: 6277 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 12, 2010 Received: April 14, 2010
Dear Ms. Chu
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).
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.
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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,
Signature
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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Indications for Use
510(k) Number (if known): 45100560
Device Name: Easy Talk Blood Glucose Monitoring System
Indications for Use:
The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × · AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_14100560 ==============================================================================================================================================================
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