Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration". November 29, 2018 Tyson Bioresearch, Inc. % Feng- Yu Lee, Regulatory Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Re: K182047 Trade/Device Name: Tyson Bio HT100-A Blood Glucose Monitoring System Tyson Bio HT100-C Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 25, 2018 Received: October 30, 2018 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # 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) #### k182047 Device Name Tyson Bio HT100-A Blood Glucose Monitoring System #### Indications for Use (Describe) The Tyson Bio HT100-A 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-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <input checked="" type="checkbox"/> | ## |X | 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 Drug 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) #### k182047 Device Name Tyson Bio HT100-C Blood Glucose Monitoring System #### Indications for Use (Describe) The Tyson Bio HT100-C 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-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NECESSARY # 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 Drug 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 serif font, with "tyson" in a larger font size than "bio". Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller, sans-serif font. ., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, www.tvsonbio.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: k182047 # 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: VANCE CHANG Phone: 886-37-585988 EXT 12001 Facsimile: 886-37-585996 Feng-Yu Lee 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: November 27th, 2018 # 2. Device name and classification Device Name: Tyson Bio HT100-A Blood Glucose Monitoring System Tyson Bio HT100-C 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 "T" made up of three colored bars: red on top, green on the left, and blue on the right. To the right of the "T" is the text "tyson bio" in a sans-serif font, with "bio" slightly smaller and raised. Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller font. � 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan し+886-37-585988 +886-37-585996 0 www.tysonbio.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-A Blood Glucose Monitoring System (with Voice feature) consists of three main components: the meter (with built-in Voice feature), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as k170079) can be used with the Tyson Bio HT100-A Blood Glucose Monitoring System. The Tyson Bio HT100-C Blood Glucose Monitoring System (with Voice and Bluetooth features) consists of three main components: the meter (with built-in Voice and Bluetooth features), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solutions (Control Solutions are the same as k170079) can be used with the Tyson Bio HT100-C Blood Glucose Monitoring System. The Tyson Bio HT100-A / HT100-C Blood Glucose Monitoring System consists of: - a. Tyson Bio HT100-A / HT100-C Blood Glucose Meter - Tyson Bio 50H Test Strips b. (Test Strips are the same as k170079) # 4. Intended use # Tyson Bio HT100-A Blood Glucose Monitoring System: The Tyson Bio HT100-A 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Tyson Bio logo. The logo consists of a stylized letter "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 the text is the tagline "Greater Measure for Life" in a smaller font size. Tyson Bioresearch Inc. No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, The Tyson Bio HT100-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip. # Tyson Bio HT100-C Blood Glucose Monitoring System: The Tyson Bio HT100-C 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-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio 50H 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 Tyson Bio HT100 Blood Glucose Monitoring System (k170079) for HT100-A Tyson Bio HT100-B Blood Glucose Monitoring System (k170079) for HT100-C ## 6.1 Tyson Bio HT100-A Blood Glucose Monitoring System #### Similarities | Item | Predicate device (k170079) | Proposed Device | |------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | | Tyson Bio HT100 Blood<br>Glucose Monitoring System | Tyson Bio HT100-A Blood<br>Glucose Monitoring System | | Intended Use | Over-The-Counter<br>Quantitative measurement of glucose (sugar) in fresh capillary<br>whole blood samples. | Over-The-Counter<br>Quantitative measurement of glucose (sugar) in fresh capillary<br>whole blood samples. | | Enzyme | Electrochemical biosensor with Glucose Dehydrogenase (FAD) | Electrochemical biosensor with Glucose Dehydrogenase (FAD) | | Test Principle | Amperometric detection | Amperometric detection | | Measuring Range | 20-600mg/dL | 20-600mg/dL | | Hematocrit Range | 10%-65% | 10%-65% | | Sample Volume | 0.7uL | 0.7uL | {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, with "tyson" in a larger font size than "bio". Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller font. � 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan し+886-37-585988 을 +886-37-585996 | ⊕ www.tysonbio.com | | |--------------------|--| |--------------------|--| | AST | Palm and forearm | | |--------------------------------|-------------------------------------------------------------|--| | Coding | Auto coding test strip | | | Operating Temperature<br>Range | 10-40 ℃ (50-104°F) | | | Operating Humidity<br>Range | 10-90% | | | Memory Capacity | 500 results with time and date | | | Battery Type | Two AAA batteries | | | Reminder Alarm | 4 user setting alarms | | | Button | Three operating button (M, up and down) One ejection button | | | Meter Size | 106 x 66 x 20 mm (LWH) | | | Bluetooth | No | | ## Differences | Item | Predicate device (k170079) | Proposed Device | |------------------------------------|---------------------------------------------------------|--------------------------------------------------------| | | Tyson Bio HT100 Blood<br>Glucose Monitoring System | Tyson Bio HT100-A Blood<br>Glucose Monitoring System | | Voice | No | Yes | | Meter Weight | 65 grams without battery | 69.8 grams without battery | | Functional Back Cover<br>Open View | Image: Predicate device functional back cover open view | Image: Proposed device functional back cover open view | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized letter "T" made up of three colored bars: red on top, green on the left, and blue on the right. 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. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan 글 +886-37-585996 +886-37-585988 0 www.tysonbio.com Image /page/8/Picture/5 description: The image shows a PCBA (Printed Circuit Board Assembly) for a functional back cover. There are two sets of images, each showing the front and back of the PCBA. The front view of the PCBA shows electronic components, while the back view shows connectors and a QR code. The text extracted from the image includes "Functional Back Cover PCBA", "Front", "Back", "50H V01B PCB-198-1", "0-1", and "94V-0". # 6.2 Tyson Bio HT100-C Blood Glucose Monitoring System # Similarities | Item | Predicate device (k170079) | Proposed Device | |--------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | | Tyson Bio HT100-B Blood<br>Glucose Monitoring System | Tyson Bio HT100-C Blood<br>Glucose Monitoring System | | Intended Use | Over-The-Counter<br>Quantitative measurement of glucose (sugar) in fresh capillary<br>whole blood samples. | | | Enzyme | Electrochemical biosensor with Glucose Dehydrogenase (FAD) | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "tyson bio". 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. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan し+886-37-585988 을 +886-37-585996 | 0 www.tysonbio.com | | |--------------------|--| | | | | Test Principle | Amperometric detection | | |--------------------------------|-------------------------------------------------------------|--| | Measuring Range | 20-600mg/dL | | | Hematocrit Range | 10%-65% | | | Sample Volume | 0.7uL | | | AST | Palm and forearm | | | Coding | Auto coding test strip | | | Operating Temperature<br>Range | 10-40 ℃ (50-104°F) | | | Operating Humidity<br>Range | 10-90% | | | Memory Capacity | 500 results with time and date | | | Battery Type | Two AAA batteries | | | Reminder Alarm | 4 user setting alarms | | | Button | Three operating button (M, up and down) One ejection button | | | Meter Size | 106 x 66 x 20 mm (LWH) | | | Bluetooth | Yes | | # Differences | Item | Predicate device(k170079) | Proposed Device | |------------------------------------|---------------------------------------------------------|--------------------------------------------------------| | | Tyson Bio HT100-B Blood<br>Glucose Monitoring System | Tyson Bio HT100-C Blood<br>Glucose Monitoring System | | Voice | No | Yes | | Meter Weight | 65 grams without battery | 70 grams without battery | | Functional Back Cover<br>Open View | Image: Predicate device functional back cover open view | Image: Proposed device functional back cover open view | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized letter "T" made up of three colored bars: red on top, green on the left, and blue on the right. 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. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan +886-37-585996 +886_27_585000 0 www.tvsonbio.com Image /page/10/Picture/5 description: The image shows a PCBA (Printed Circuit Board Assembly) for a functional back cover. There are two sets of images, each showing the front and back of the PCBA. The PCBA has electronic components on the front side and connection points on the back. The text on the PCBA includes "50H V01B PCB-198-1" and "94V-0". # 7. Conclusion The Tyson Bio HT100-A and HT100-C Blood Glucose Monitoring Systems are substantially equivalent to the predicate device.