The Tyson Bio HT100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip.

The Tyson Bio HT100-B Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip.

Device Description

The Tyson Bio HT100 Blood Glucose Monitoring System consists of three main components: the meter, test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100 Test Strips and Tyson Bio HT100 Control Solution with the Tyson Bio HT100 Blood Glucose Monitoring System.

The Tyson Bio HT100-B Blood Glucose Monitoring System (with Bluetooth feature) consists of three main components: the meter (with built-in Bluetooth), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100-B Test Strips and Tyson Bio HT100-B Control Solution with the Tyson Bio HT100-B Blood Glucose Monitoring System.

The Tyson Bio HT100 / HT100-B Blood Glucose Monitoring System consists of:

Tyson Bio HT100 / HT100-B Blood Glucose Meter
Tyson Bio HT100 / HT100-B Test Strips

AI/ML Overview

The Tyson Bio HT100 and HT100-B Blood Glucose Monitoring Systems are intended for the quantitative measurement of glucose in fresh capillary whole blood samples.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Performa device, K133741) rather than explicitly stating specific numerical acceptance criteria for accuracy. However, it does present linear regression analysis results from a system accuracy study. For blood glucose monitoring systems, common accuracy criteria involve certain percentages of results falling within specific glucose concentration ranges compared to a laboratory reference. Without the explicit mention of these criteria, we can only infer performance based on the regression results.

Metric (Inferred)	Acceptance Criteria (Implicit for Substantial Equivalence to Predicate)	Reported Device Performance (Tyson Bio HT100, combined three lots)
Slope of linear regression	Close to 1.000	0.9966
Intercept of linear regression	Close to 0.000	0.0053
R² (Coefficient of Determination)	Close to 1.000	0.9892
95% Confidence Interval of Slope	Should contain 1.000	0.9861 to 1.007
95% Confidence Interval of Intercept	Should contain 0.000	-0.7270 to 3.487
User Accuracy	Device meets acceptance criteria (implied by study results)	Met acceptance criteria
Ease of Use	Device meets acceptance criteria (implied by study results)	Met acceptance criteria (via participant questionnaire scoring)

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

System Accuracy Study:
- Sample Size: 127 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "patients," suggesting human subjects. It's a clinical study, implying prospective data collection during the study.
User Performance Study:
- Sample Size: 121 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "lay users," suggesting human subjects. It's a clinical study, implying prospective data collection during the study.

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

For the System Accuracy Study, the ground truth was established by a laboratory instrument: YSI 2300 Plus Glucose Analyzer. This is a common and high-accuracy reference method for glucose measurement. No human experts are explicitly mentioned for establishing this ground truth, as it relies on the calibrated laboratory instrument.
For the User Performance Study, the ground truth for "user accuracy" would indirectly come from comparing user-obtained results to a reference standard (likely the YSI device or similar, though not explicitly stated for this particular study). No "experts" are mentioned as establishing ground truth in the sense of adjudication for this specific study; rather, it assesses the lay user's ability to operate the device correctly.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method (like 2+1, 3+1, or none) for either the system accuracy study or the user performance study.
For the system accuracy study, the comparison is directly between the test device and the laboratory reference instrument (YSI 2300 Plus Glucose Analyzer), so human adjudication of results is not typically applicable in this context.
For the user performance study, the focus is on whether users can obtain accurate results by following instructions, rather than on subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
This device is a blood glucose monitoring system, and the studies performed (system accuracy and user performance) are typical for this type of in-vitro diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance assessment was effectively done through the "Method Comparison / System Accuracy Study." In this study, the Tyson Bio HT100 Blood Glucose Monitoring System's readings were directly compared against the YSI 2300 Plus Glucose Analyzer. This represents the algorithm's (and integrated system's) performance without direct human judgment influencing the measurement itself, beyond the initial blood sample collection and device operation.

7. Type of Ground Truth Used:

For the System Accuracy Study, the ground truth used was laboratory reference measurement (YSI 2300 Plus Glucose Analyzer).
For the User Performance Study, the ground truth for user accuracy would be a reference measurement obtained during the study (likely using the YSI device or a similar highly accurate method), to which the user's readings are compared. The "ease of use" ground truth would be established by participant questionnaire scoring against predefined criteria.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. For these types of devices, particularly with established electrochemical biosensor technology, the development (which might involve 'training' in a broad sense) often relies on extensive in-house testing, calibration, and optimization using many samples and iterations, but these aren't typically documented as a distinct "training set" in the same way machine learning models are. The emphasis in the submission is on validation.

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

Since a specific "training set" is not mentioned or detailed, there is no information provided on how its ground truth was established. The development of the device would have involved calibration and quality control procedures against reference methods, but this is distinct from a formal training set for an AI/ML model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 6. 2017

TYSON BIORESEARCH, INC. C/O FENG-YU LEE IVDD REGULATORY CONSULTANT 29222 RANCHO VIEJO ROAD SAN JUAN CAPISTRANO CA 92675

Re: K170079

Trade/Device Name: Tyson Bio HT100 Blood Glucose Monitoring System Tyson Bio HT100-B Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: September 7, 2017 Received: September 8, 2017

Dear Feng-Yu Lee:

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/ResourcesforYou/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,

Kellie B. Kelm -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) K170079

Device Name

Tyson Bio HT100-B Blood Glucose Monitoring System

Indications for Use (Describe)

The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K170079

Device Name

Tyson Bio HT100 Blood Glucose Monitoring System

Indications for Use (Describe)

The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized "T" made up of three different colored bars: red, green, and blue. To the right of the "T" is the text "tyson bio" in a simple, sans-serif font. Below the text "tyson bio" is the tagline "Greater Measure for Life" in a smaller font.

5F, No. 22, Kedong 3rd Rd., Zhunan Science Park,
Miaoli County, 35053, Taiwan
+886-37-585988 +886-37-585996
www.tysonbio.com

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K170079

1. Submitter's Identification:

Tyson Bioresearch, Inc. 5F, No.16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan (R.O.C.) Correspondent: WEN-HAI TSAI Phone: 886-37-585988 EXT 350 Facsimile: 886-37-585996

c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: October 2nd, 2017

2. Device name and classification

Device Name:

Tyson Bio HT100 Blood Glucose Monitoring System

Tyson Bio HT100-B Blood Glucose Monitoring System

Common Names:

Blood Glucose Monitoring System

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Tyson Bio logo. The logo consists of a stylized letter "T" made up of three different colored bars: red, green, and blue. To the right of the "T" is the word "tyson bio" in black, with "tyson" in a larger font than "bio". Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller, black font.

5F. No. 22. Kedong 3rd Rd., Zhunan Science Park. +886-37-585988 +886-37-585996 1 www.tvsonbio.com

Classification:

Classification Regulation: 21 CFR 862.1345 Classification: Class II (Glucose Test System) Product Codes :

NBW (System, Test, Blood Glucose, Over-the-Counter) Panel - Clinical Chemistry and Toxicology

3. Device description

The Tyson Bio HT100 / HT100-B Blood Glucose Monitoring System consists of:

Tyson Bio HT100 / HT100-B Blood Glucose Meter a.
Tyson Bio HT100 / HT100-B Test Strips b.

4. Intended use

Tyson Bio HT100 Blood Glucose Monitoring System:

The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Tyson Bio logo. The logo consists of a stylized "T" made up of three different colored lines: red, green, and blue. To the right of the "T" is the text "tyson bio" in a simple, sans-serif font. Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller font.

5F, No. 22, Kedong 3rd Rd., Zhunan Science Park,
Miaoli County, 35053, Taiwan
+886-37-585988 +886-37-585996
www.tysonbio.com

Tyson Bio HT100-B Blood Glucose Monitoring System:

The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip.

5. Test principle

The test principle is based on electrochemical biosensor technology using glucose dehydrogenase. There has been no change to the fundamental scientific technology.

6. Predicate device

ACCU-CHEK Performa device (K133741)

6.1 Tyson Bio HT100 Blood Glucose Monitoring System

Differences

Item	Proposed Device	Predicate Device (K133741)
	Tyson Bio HT100 BloodGlucose Monitoring System	ACCU-CHEK Performa BloodGlucose Monitoring System
Enzyme	Electrochemical biosensor withGlucose Dehydrogenase (FAD)	Electrochemical biosensor withGlucose Dehydrogenase – PQQmodified by site-directedmutagenesis (Mutant Q-GDH)
Sample volume	0.7uL	0.6uL
AST	Palm and forearm	-
Hematocrit range	10%~65%	10%~65%
Operating TemperatureRange:	10 to 40 °C (50-104°F)	16 to 35 °C (61-95°F)
Humidity	10-90%	10-80%
Coding	Auto coding test strip	Code key inserts directly intocode key slot in meter.
Battery Type:	Two AAA batteries	One CR2032
Reminder alarm	4 user setting alarms	Post-Meal Test Alarm
Button	Three operating button (M, upand down) One ejection button	Three operating buttons (Power,up and down)
Meter size	106 x 66 x 20 mm (LWH)	93 x 52 x 22 mm (LWH)
Meter weight	65 grams without battery	Approx. 62 grams (with battery)

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized letter "T" made up of three different colored bars: red, green, and blue. To the right of the "T" is the text "tyson bio" in a sans-serif font. Below the text is the tagline "Greater Measure for Life" in a smaller font.

♥ 5F, No. 22, Kedong 3rd Rd., Zhunan Science Park, Miaoli County, 35053, Taiwan ん+886-37-585988 을 +886-37-585996

መ www.tysonbio.com

Similarities

Item	Proposed Device	Predicate Device (K133741)
	Tyson Bio HT100 BloodGlucose Monitoring System	ACCU-CHEK Performa BloodGlucose Monitoring System
Intended Use	Over-The-CounterQuantitative measurement of glucose (sugar) in fresh capillarywhole blood samples.
Test principle	Amperometric detection
Test Sample	Capillary Whole Blood from Fingertip
Measuring Range	20-600mg/dL
Memory capacity	500 results with time and date

6.2 Tyson Bio HT100-B Blood Glucose Monitoring System

Differences

Item	Proposed Device	Predicate Device (K133741)
	Tyson Bio-B HT100 BloodGlucose Monitoring System	ACCU-CHEK Performa BloodGlucose Monitoring System
Enzyme	Electrochemical biosensor withGlucose Dehydrogenase (FAD)	Electrochemical biosensor withGlucose Dehydrogenase - PQQmodified by site-directedmutagenesis (Mutant Q-GDH)
Sample volume	0.7uL	0.6uL
AST	Palm and forearm
Hematocrit range	10%~65%	10%~65%
Operating TemperatureRange:	10 to 40 ℃ (50-104ºF)	16 to 35 ℃ (61-95ºF)
Humidity	10-90%	10-80%
Coding	Auto coding test strip	Code key inserts directly intocode key slot in meter.
Battery Type:	Two AAA batteries	One CR2032
Reminder alarm	4 user setting alarms	Post-Meal Test Alarm
Button	Three operating button (M, upand down) One ejection button	Three operating buttons (Power,up and down)
Meter size	106 x 66 x 20 mm (LWH)	93 x 52 x 22 mm (LWH)
Meter weight	65 grams without battery	Approx. 62 grams (with battery)
Bluetooth	Yes	No

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the Tyson Bio logo. The logo consists of a stylized letter "T" made up of three different colored bars: red, green, and blue. To the right of the "T" is the text "tyson bio" in a simple, sans-serif font. Below the text is the tagline "Greater Measure for Life" in a smaller font size.

unan Science Park

⊕ www.tysonbio.com

Similarities

Item	Proposed Device	Predicate Device (K133741)
	Tyson Bio HT100-B BloodGlucose Monitoring System	ACCU-CHEK Performa BloodGlucose Monitoring System
Intended Use	Over-The-CounterQuantitative measurement of glucose (sugar) in fresh capillarywhole blood samples.
Test principle	Amperometric detection
Test Sample	Capillary Whole Blood from Fingertip
Measuring Range	20-600mg/dL
Memory capacity	500 results with time and date

7. Performance characteristic summary

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Verification and validation of these blood glucose systems evaluated to establish the performance, functionality, and reliability of the Tyson Bio HT100 Blood Glucose Monitoring System, and Tyson Bio HT100-B Blood Glucose Monitoring System. The evaluation included precision, linearity, interference, sample volume and hematocrit.

Discussion of Clinical Tests Performed:

Method Comparison / System Accuracy Study:

The system accuracy study of the Tyson Bio HT100 Blood Glucose Monitoring System and Tyson Bio HT100-B Blood Glucose Monitoring System was performed by comparing capillary whole blood glucose values on the Tyson Bio HT100 Blood Glucose Monitoring System with glucose values on lab instrument YSI 2300 Plus Glucose Analyzer.

A total of 127 patients participated. The study results demonstrate that the accuracy of Tyson Bio HT100 Blood Glucose Monitoring System met the acceptance criteria.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized letter "T" made up of three different colored bars: red, green, and blue. To the right of the "T" is the text "tyson bio" in a simple, sans-serif font. Below the text is the tagline "Greater Measure for Life" in a smaller font.

Tyson Bioresearch Inc.

an Science Park

⊕ www.tysonbio.com

Values obtained from meters compared with YSI results; linear results regression analysis yielded the following results:

Fingertip	Predicate device	Proposed Devices Tyson Bio HT100
	Performa	LOT 1	LOT 2	LOT 3
N	127	127	127	127
Slope	0.969	0.988	1.004	0.998
Intercept	2.408	1.950	1.684	0.504
R2	0.9871	0.9921	0.9874	0.9887

Combined Tyson Bio HT100 three lots yield the following result:

Regression	y=0.9966x+0.0053
95% CI of slope	0.9861 to 1.007
95% CI of intercept	-0.7270 to 3.487
R2	0.9892

User Performance Study:

The user performance study was performed to demonstrate that English speaking and reading lay users across all educational backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Tyson Bio HT100 Blood Glucose Monitoring System and Tyson Bio HT100-B Blood Glucose Monitoring System.

A total of 121 subjects participated. The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Tyson Bio HT100 Blood Glucose Monitoring System and Tyson Bio HT100-B Blood Glucose Monitoring System meet the acceptance criteria.

8. Conclusion

The Tyson Bio HT100 and HT100-B Blood Glucose Monitoring Systems are substantially equivalent to the predicate device.

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.