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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the DIACHEX Blood Glucose Monitoring System, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Study Findings for DIACHEX Blood Glucose Monitoring System (K062829)

Based on the provided 510(k) Summary for K062829, the DIACHEX Blood Glucose Monitoring System is presented as substantially equivalent to the EZ Smart-168 Blood Glucose Monitoring System (K052818). The core of the justification for substantial equivalence lies in the established performance characteristics of the predicate device and the assertion that the changes in the DIACHEX device do not impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state separate "acceptance criteria" for the DIACHEX device against which a new study's results are presented. Instead, it relies on the predicate device's established performance and asserts that the DIACHEX device maintains these through direct comparison and evaluation of specific parameters. The table below compiles the performance parameters mentioned and the implied "reported performance" for DIACHEX, which is stated as being "the same" or "similar" to the predicate.

Feature/Performance Parameter	Predicate Device (EZ Smart-168) (K052818)	Proposed Device (DIACHEX)	Acceptance Criteria (Implied)	DIACHEX Reported Performance (Claimed)
Intended Use	Measure glucose in capillary whole blood from fingertip for home/professional settings.	Same	Equivalent to predicate	Same as predicate
Test Principle	Electrochemical biosensor with glucose oxidase.	Same	Equivalent to predicate	Same as predicate
Specimen Type	Capillary whole blood from fingertip	Same	Equivalent to predicate	Same as predicate
Sample Volume	Around 1.5 µL	Same	Equivalent to predicate	Same as predicate
Measuring Time	10 seconds	Same	Equivalent to predicate	Same as predicate
Detecting Range (Glucose)	20 ~ 600 mg/dL	Same	Equivalent to predicate	Same as predicate
HCT Range	35 ~ 55 %	Same	Equivalent to predicate	Same as predicate
Operating Temperature	10 to 40 °C (50-104°F)	Same	Equivalent to predicate	Same as predicate
Strip Storage Temperature	4 to 30 ℃ (40-86°F)	Same	Equivalent to predicate	Same as predicate
Battery Power	One 3 V Lithium CR 2032 battery	Same	Equivalent to predicate	Same as predicate
Meter Coding	Glucode Chip	Same	Equivalent to predicate	Same as predicate

Changes from Predicate (and implied maintenance of performance):

Item	Predicate Device	Proposed Device	Implied Impact on Performance
Test Strips size	33.5 x 5 (mm)	33.5 x 7 (mm)	Claimed no impact on performance
Average result	Only 28 tests average	14-Day Average	Software feature, no impact on core measurement performance
Memory capacity	28 Test Results	300 Test Results	Software feature, no impact on core measurement performance
Button Design	One button	Two buttons	User interface, no impact on core measurement performance
PCB Size	72 x 42 (mm)	92 x 44 (mm)	Internal component size, claimed no impact on core measurement performance
Meter Dimension	76 x 47 x 16 (mm)	102 x 52 x 17 (mm)	Physical size, claimed no impact on core measurement performance
Meter Weight	44 grams	55 grams	Physical weight, claimed no impact on core measurement performance
LCD Display	40 x 21.5 (mm)	37.5 x 34 (mm)	Physical size, no impact on core measurement performance

The core "acceptance criteria" here appear to be focused on maintaining equivalence to the predicate device across all critical performance parameters. The "reported device performance" is essentially that the DIACHEX device demonstrates this equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for the evaluations conducted on the DIACHEX system. It only states that "An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For blood glucose monitoring systems, "ground truth" often refers to reference methods (e.g., YSI glucose analyzer) rather than expert consensus on individual readings.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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 DIACHEX Blood Glucose Monitoring System is a standalone diagnostic device for quantitative glucose measurement and does not involve human readers interpreting images or data where AI assistance would be relevant for improving reader performance. There is no AI component mentioned.

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

Yes, a "standalone" evaluation was done in the sense that the device's inherent performance was assessed. The statement "An evaluation of the DIACHEX Blood Glucose Monitoring System was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity" describes performance testing of the device itself, without necessarily involving a human operator measuring their own performance alongside the device. The data presented essentially represents the algorithm/device's performance.

7. The Type of Ground Truth Used:

For blood glucose monitoring systems, the "ground truth" for evaluating accuracy is typically established using a laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated for the DIACHEX evaluation, the predicate device comparison implies that any performance evaluations would have used similar established laboratory methods as the gold standard, given that the DIACHEX "is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods" (stated in the device description and test principle).

8. The Sample Size for the Training Set:

This information is not provided and is largely irrelevant in the context of this device. The DIACHEX system is based on electrochemical biosensor technology, not a machine learning model that requires a distinct "training set." Its calibration is based on established chemical principles and comparison to reference methods, not iterative training data.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable as there is no "training set" in the context of a machine learning algorithm. The device's calibration and accuracy are established through its electrochemical design and validation against laboratory reference methods.

In conclusion:

The 510(k) submission for the DIACHEX Blood Glucose Monitoring System relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (EZ Smart-168 Blood Glucose Monitoring System K052818). The core argument is that fundamental scientific technology, operating principles, and critical performance parameters remain unchanged, despite minor physical and user interface modifications.

The provided document briefly mentions that an "evaluation" was conducted covering temperature effects, hematocrit levels, sensitivity, and linearity to demonstrate equivalence. However, it lacks specific details regarding the methodology of this evaluation, including sample sizes, data provenance, ground truth establishment methods, or detailed results, typically found in a full study report. The acceptance criteria are implicitly met by demonstrating that the new device's performance aligns with the established and accepted performance parameters of the predicate device.

Summary

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K062829

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:

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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:

Similarities:

Item	Predicate DeviceEZ Smart-168 (K052818)	Proposed DeviceDIACHEX
Intend Use	The EZ Smart-168 Blood GlucoseTest Strips are used with the EZSmart-168 Blood Glucose Meter tomeasure glucose (sugar) incapillary whole blood fromfingertip. The EZ Smart-168 TestStrips are for testing outside thebody (in vitro diagnostic use). TheEZ Smart-168 Blood GlucoseMonitoring System provides aconvenient and safe monitoringsystem for diabetes health careprofessionals, hospitals and mostimportantly people with diabetes.	The DIACHEX Blood GlucoseTest Strips are used with theDIACHEX Blood Glucose Meterto measure glucose (sugar) incapillary whole blood fromfingertip. The DIACHEX TestStrips are for testing outside thebody (in vitro diagnostic use). TheDIACHEX Blood GlucoseMonitoring System provides aconvenient and safe monitoringsystem for diabetes health careprofessionals, hospitals and mostimportantly people with diabetes.
Test Principle	Electrochemical biosensor withglucose oxidase.	Electrochemical biosensor withglucose oxidase.
Test Strips	EZ Smart-168 Test Strip	DIACHEX Test Strip
Specimen Type	Capillary whole blood fromfingertip	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
OperatingTemperature	10 to 40 °C (50-104°F)	Same

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Item	Predicate DeviceEZ Smart-168 (K052818)	Proposed DeviceDIACHEX
Strip StorageTemperature	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 DeviceEZ Smart-168 (K052818)	Proposed DeviceDIACHEX
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:

K062829

Device Name:

DIACHEX Blood Glucose Monitoring System

Indications For Use:

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)

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.