(20 days)
Not Found
No
The summary describes a standard amperometric biosensor for blood glucose measurement and does not mention any AI or ML components or capabilities.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for providing therapy. While it aids in better glucose control, it does not directly treat or cure a disease.
Yes
Explanation: The device is used to quantitatively measure glucose in blood to monitor blood glucose levels, which is a diagnostic purpose. The text states it is for "in vitro diagnostic use."
No
The device description explicitly mentions a "Blood Glucose Meter" and "Blood Glucose Test Strips," which are physical hardware components used for measuring glucose. The system is described as an "amperometric biosensor," further indicating a hardware-based measurement process.
Yes, based on the provided text, the DIACHEX Blood Glucose Test Strips and the overall DIACHEX Blood Glucose Monitoring System are explicitly stated to be an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly states, "The DIACHEX Strips are for testing outside the body (in vitro diagnostic use)." This is a direct declaration of its IVD status.
- Device Description: The description reinforces this by explaining how the system measures glucose in blood outside the body.
Therefore, there is no ambiguity; the device is an IVD.
N/A
Intended Use / Indications for Use
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.
Product codes
75CGA, 75NBW, NBW, CGA
Device Description
The DIACHEX Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, are adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip. When the edge of the DIACHEX Test Strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and in professional settings
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)
An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity. The results of the evaluation demonstrate that the DIACHEX Blood Glucose Monitoring System is equivalent in performance to the predicate device and suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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510(k) SUMMARY
1. DATE PREPARED
September 18, 2006
OCT 1 0 2006
2. SPONSOR INFORMATION
Address
TYSON BIORESEARCH, INC. 5 F., # 22, KE TUNG RD., SCIENCE BASED INDUSTRIAL PARK CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350
Contact Person: WEN-HAI TSAI
PHONE: 886-37-585988 FACSIMILE: 886-37-585996
3. NAME OF DEVICE:
Trade Name: Common Names/Descriptions: Classification Names:
DIACHEX Blood Glucose Monitoring System Blood Glucose Monitoring System Glucose test system, product code 75CGA and "System, test, blood glucose, over the counter", product code 75NBW, 21 CFR 862.1345
4. DEVICE DESCRIPTION:
The DIACHEX Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, are adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. DIACHEX device provides a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter to quantitatively measure glucose in capillary whole blood obtained from the fingertip. When the edge of the DIACHEX Test Strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed
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on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.
5. INTENDED USE:
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
6. TEST PRINCIPLE
The test principle is based on electrochemical biosensor technology using glucose oxidase. Glucose is oxidized to gluconic acid and electrons are produced from the reaction. The electrons are then trapped by a chemical mediator, potassium ferricyanide. Once the enzymatic reaction is complete, a potential is provided by the meter for a further electrochemical reaction in order to generate a current from the release of trapped electrons. This current is then measured and correlated to the glucose concentration in the whole-blood sample. The DIACHEX Test Strip is calibrated to display the equivalent of plasma glucose values to allow easy comparison of results with laboratory methods.
7. PREDICATE DEVICE:
Predicate device name(s): EZ Smart - 168 Blood Glucose Monitoring System
Predicate 510(k) number(s): K052818
Comparison with predicate:
The Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System in this submission is equivalent to the Tyson Bioresearch Inc. EZ Smart-168 Blood Glucose Monitoring System previously cleared under (K052818). DIACHEX Blood Glucose Monitoring System is an amendment to the EZ Smart-168 Blood Glucose Monitoring System (K052818). This amendment addresses only small changes on the meter size, appearance, memory capacity, date, time and 14days average testing result. All main internal electronic components and meter functions remain as same as the EZ Smart-168
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Blood Glucose Meter. DIACHEX Test Strip also identical to the EZ Smart-168 Test Strip, only the size changed for more convenient use. Fundamental scientific technology of the DIACHEX device has not changed.
Substantial Equivalence Comparison:
The Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System in this submission is equivalent to the Tyson Bioresearch Inc. EZ Smart-168 Blood Glucose Monitoring System previously cleared under (K052818). The table below lists the similarities and differences between the Predicate and Proposed device.
Similarities:
| Item | Predicate Device
EZ Smart-168 (K052818) | Proposed Device
DIACHEX |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend Use | The EZ Smart-168 Blood Glucose
Test Strips are used with the EZ
Smart-168 Blood Glucose Meter to
measure glucose (sugar) in
capillary whole blood from
fingertip. The EZ Smart-168 Test
Strips are for testing outside the
body (in vitro diagnostic use). The
EZ Smart-168 Blood Glucose
Monitoring System provides a
convenient and safe monitoring
system for diabetes health care
professionals, hospitals and most
importantly people with diabetes. | The DIACHEX Blood Glucose
Test Strips are used with the
DIACHEX Blood Glucose Meter
to measure glucose (sugar) in
capillary whole blood from
fingertip. The DIACHEX Test
Strips are for testing outside the
body (in vitro diagnostic use). The
DIACHEX Blood Glucose
Monitoring System provides a
convenient and safe monitoring
system for diabetes health care
professionals, hospitals and most
importantly people with diabetes. |
| Test Principle | Electrochemical biosensor with
glucose oxidase. | Electrochemical biosensor with
glucose oxidase. |
| Test Strips | EZ Smart-168 Test Strip | DIACHEX Test Strip |
| Specimen Type | Capillary whole blood from
fingertip | Same |
| Sample Volume | Around 1.5 uL | Same |
| Measuring Time | 10 sec | Same |
| Detecting Range | 20 ~ 600 mg/dL | Same |
| HCT Range | 35 ~55 % | Same |
| Operating
Temperature | 10 to 40 °C (50-104°F) | Same |
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| Item | Predicate Device
EZ Smart-168 (K052818) | Proposed Device
DIACHEX |
|------------------------------|--------------------------------------------|----------------------------|
| Strip Storage
Temperature | 4 to 30 ℃ (40-86°F) | Same |
| Battery Power | One 3 V Lithium CR 2032 battery | Same |
| Meter Coding | Glucode Chip | Same |
Differences:
| Item | Predicate Device
EZ Smart-168 (K052818) | Proposed Device
DIACHEX |
|------------------|--------------------------------------------|----------------------------|
| Test Strips size | 33.5 x 5 (mm) | 33.5 x 7 (mm) |
| Average result | Only 28 tests average | 14-Day Average |
| Memory capacity | 28 Test Results | 300 Test Results |
| Button Design | one button | Two buttons |
| PCB Size | 72 x 42 (mm) | 92 x 44 (mm) |
| Meter Dimension | 76 x 47 x 16 (mm) | 102 x 52 x 17 (mm) |
| Meter Weight | 44 grams | 55 grams |
| LCD Display | 40 x 21.5 (mm) | 37.5 x 34 (mm) |
8. PERFORMANCE CHARACTERISTIC SUMMARY
Based on the above information, we know the subject device, DIACHEX Blood Glucose Monitoring System, and the predicate device have functioning principle and using the same technologies. The detection ranges for both devices are similar. HCT ranges are the same. The strip storage environments and the operating temperature are similar.
The differences between DIACHEX from EZ Smart-168 Blood Glucose Monitoring System are meter dimension, weight, memory capacity, 14 days average result, date and time display, all internal electrical architectures and main electronic components as well as product functions and features remain unchanged. DIACHEX Test Strip is also identical to the EZ Smart-168 Blood Glucose Monitoring System, only the size changed for more convenient use. No physical changes of EZ Smart-168 Test Strips were made.
As we can see, the differences are due to the feature design aspects for more convenience
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use of the DIACHEX Blood Glucose Monitoring System, not relating to the safety or effectiveness aspects. Fundamental scientific technology of the DIACHEX device has not changed. DIACHEX Blood Glucose Monitoring System is substantially equivalent to the originally cleared EZ Smart-168 Blood Glucose Monitoring System (K052818).
An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity. The results of the evaluation demonstrate that the DIACHEX Blood Glucose Monitoring System is equivalent in performance to the predicate device and suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 0 2006
Mr. Wen-Hai Tsai Tyson Bioresearch, Inc. 5F., #22, Ke Tung Rd., Science Based Industrial Park Chun-Nan, Miao-Li County, China (Taiwan) 350
K062829 Trade/Device Name: DIACHEX Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 19, 2006 Received: September 20, 2006
Dear Mr. Tsai:
Re:
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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) rus lotter will and will you to begin and equivalence of your device of your device to a legally promation notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or you costs on the promotion and advertising of your device, please contact the Office of In of tro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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 I ba may of annoutics griticional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, 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:
Device Name:
DIACHEX Blood Glucose Monitoring System
Indications For Use:
The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.
Division Sign-Off
Office of In Vitro Diganost Device Evaluation and Safety
510(k) K062829
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (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)