(269 days)
Not Found
No
The summary describes a standard blood glucose monitoring system based on electrochemical measurement, with no mention of AI or ML in the intended use, device description, or performance studies. The studies described are standard accuracy and user performance tests for this type of device.
No
This device is for monitoring glucose levels, which is a diagnostic aid for managing diabetes, not a therapeutic intervention itself.
No
The device is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It explicitly states, "It is not indicated for the diagnosis of or screening for diabetes or for neonatal use." This indicates it's for monitoring, not for initial diagnosis.
No
The device description explicitly states that the system consists of a meter, test strip, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
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 a.
- Tyson Bio HT100 / HT100-B Test Strips b.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing by people with diabetes 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fingertip (Proposed Devices Tyson Bio HT100 LOT 1, LOT 2, LOT 3 vs YSI results):
N: 127 for each lot
Slope: 0.988 (LOT 1), 1.004 (LOT 2), 0.998 (LOT 3)
Intercept: 1.950 (LOT 1), 1.684 (LOT 2), 0.504 (LOT 3)
R2: 0.9921 (LOT 1), 0.9874 (LOT 2), 0.9887 (LOT 3)
Combined Tyson Bio HT100 three lots:
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
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.
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 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.
| 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 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.
| 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."
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 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 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 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.
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 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.
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 Blood | ||
| Glucose Monitoring System | ACCU-CHEK Performa Blood | |
| Glucose Monitoring System | ||
| Enzyme | Electrochemical biosensor with | |
| Glucose Dehydrogenase (FAD) | Electrochemical biosensor with | |
| Glucose Dehydrogenase – PQQ | ||
| modified by site-directed | ||
| mutagenesis (Mutant Q-GDH) | ||
| Sample volume | 0.7uL | 0.6uL |
| AST | Palm and forearm | - |
| Hematocrit range | 10%~65% | 10%~65% |
| Operating Temperature | ||
| Range: | 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 into |
| code 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, up | |
| and 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
Similarities
| Item | Proposed Device | Predicate Device (K133741) |
|---|---|---|
| Tyson Bio HT100 Blood | ||
| Glucose Monitoring System | ACCU-CHEK Performa Blood | |
| Glucose Monitoring System | ||
| Intended Use | Over-The-Counter | |
| Quantitative measurement of glucose (sugar) in fresh capillary | ||
| whole 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 Blood | ||
| Glucose Monitoring System | ACCU-CHEK Performa Blood | |
| Glucose Monitoring System | ||
| Enzyme | Electrochemical biosensor with | |
| Glucose Dehydrogenase (FAD) | Electrochemical biosensor with | |
| Glucose Dehydrogenase - PQQ | ||
| modified by site-directed | ||
| mutagenesis (Mutant Q-GDH) | ||
| Sample volume | 0.7uL | 0.6uL |
| AST | Palm and forearm | |
| Hematocrit range | 10%~65% | 10%~65% |
| Operating Temperature | ||
| Range: | 10 to 40 ℃ (50-104ºF) | 16 to 35 ℃ (61-95ºF) |
| Humidity | 10-90% | 10-80% |
| Coding | Auto coding test strip | Code key inserts directly into |
| code 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, up | |
| and 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 |
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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
Similarities
| Item | Proposed Device | Predicate Device (K133741) |
|---|---|---|
| Tyson Bio HT100-B Blood | ||
| Glucose Monitoring System | ACCU-CHEK Performa Blood | |
| Glucose Monitoring System | ||
| Intended Use | Over-The-Counter | |
| Quantitative measurement of glucose (sugar) in fresh capillary | ||
| whole 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
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.