(122 days)
Not Found
No
The description focuses on standard blood glucose monitoring technology and does not mention any AI or ML components.
No
This device is an In Vitro Diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition. Its output aids in monitoring the effectiveness of diabetes control, but it does not provide therapy itself.
Yes
The "Intended Use / Indications for Use" section states, "Testing is done outside the body (In Vitro diagnostic use)." This explicitly classifies the device as a diagnostic device.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This statement directly identifies the device's intended use as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Tyson Bio HS100 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 HS100-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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Tyson Bio HS100 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. 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 HS100 Blood Glucose Monitoring System.
The Tyson Bio HS100-B Blood Glucose Monitoring System consists of three main components: the meter (with Bluetooth 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 Solutions (Control Solutions are the same as K170079) can be used with the Tyson Bio HS100-B Blood Glucose Monitoring System.
The Tyson Bio HS100 / HS100-B Blood Glucose Monitoring System consists of:
- Tyson Bio HS100 / HS100-B Blood Glucose Meter a.
- b. Tyson Bio 50H Blood Glucose Test Strips (Test Strips are the same as K170079)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, or palm (fresh capillary whole blood samples drawn from)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.
November 30, 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: K182046
Trade/Device Name: Tyson Bio HS100 Blood Glucose Monitoring System Tyson Bio HS100-B Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 31, 2018 Received: October 31, 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 may, 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 aware 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 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
1
- 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 medical devices and radiation-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)
Device Name
Tyson Bio HS100 Blood Glucose Monitoring System
Indications for Use (Describe)
The Tyson Bio HS100 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 HS100 Blood Glucose Monitoring System is comprised of the Tyson Bio HS100 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) | 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)
K182046
Device Name Tyson Bio HS100-B Blood Glucose Monitoring System
Indications for Use (Describe)
The Tyson Bio HS100-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 HS100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS100-B 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) | 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."
4
Image /page/4/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 black, with "tyson" in a larger font than "bio". Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller, lighter font.
18, 20, 22, Kedong 3rd Rd., Zhunan Township,
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: K182046
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
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 28th, 2018
2. Device name and classification
Device Name:
Tyson Bio HS100 Blood Glucose Monitoring System
Tyson Bio HS100-B Blood Glucose Monitoring System
Common Names:
Blood Glucose Monitoring System
5
Image /page/5/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 "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 Countv 35053. Taiwan +886-37-585988 +886-37-585996 D 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 HS100 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. 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 HS100 Blood Glucose Monitoring System.
The Tyson Bio HS100-B Blood Glucose Monitoring System consists of three main components: the meter (with Bluetooth 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 Solutions (Control Solutions are the same as K170079) can be used with the Tyson Bio HS100-B Blood Glucose Monitoring System.
The Tyson Bio HS100 / HS100-B Blood Glucose Monitoring System consists of:
- Tyson Bio HS100 / HS100-B Blood Glucose Meter a.
- b. Tyson Bio 50H Blood Glucose Test Strips (Test Strips are the same as K170079)
4. Intended use
Tyson Bio HS100 Blood Glucose Monitoring System:
The Tyson Bio HS100 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 HS100 Blood Glucose Monitoring System is comprised of the Tyson Bio HS100 Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.
6
Image /page/6/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 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. Below the text is the tagline "Greater Measure for Life" in a smaller font.
Kedong 3rd Rd., Zhunan Township,
Tyson Bio HS100-B Blood Glucose Monitoring System:
The Tyson Bio HS100-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 HS100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS100-B 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 HS100
Tyson Bio HT100-B Blood Glucose Monitoring System (K170079) for HS100-B
6.1 Tyson Bio HS100 Blood Glucose Monitoring System
- Similarities:
| Predicate device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100 Blood | |
| Glucose Monitoring System | Tyson Bio HS100 Blood | |
| Glucose Monitoring System | ||
| Intended Use | Over-The-Counter | |
| Quantitative measurement of glucose (sugar) in fresh capillary | ||
| whole blood samples. | ||
| Enzyme | Electrochemical biosensor with Glucose Dehydrogenase (FAD) | |
| 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 | ||
| Range | 10-40 °C (50-104°F) | |
| Operating Humidity | ||
| Range | 10-90% | |
| Memory Capacity | 500 results with time and date | |
| Bluetooth | No |
7
Image /page/7/Picture/0 description: The image shows the logo for Tyson Bio. The logo consists of a stylized "T" made up of three bars in red, green, and blue, followed by the words "tyson bio" in black, with "tyson" in a cursive font and "bio" in a sans-serif font. Below "tyson bio" is the tagline "Greater Measure for Life" in a smaller, sans-serif font.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township,
+886-37-585988 +886-37-585
www.tysonbio.com
Differences:
l
The item list of differences from predicate device:
- (1) Meter size change
- (2) Ejection button color change
- (3) Ejection button position change
- (4) Operation button size change
- (5) Removal of USB transfer:
- (6) LCD interface change- "Month" and "Day" are displayed in the upper left corner of the LCD screen
- (7) LCD interface change- Remove one display bar in the upper left corner of the LCD screen
- (8) LCD interface change- Remove "AM" in the upper right corner of the LCD screen.
- (9) User interface change-"Month" and "Day" are displayed on the LCD when user doing:
- Date Setup
- Blood Glucose Measurement l
- l Control Solution Measurement
- l View the memory for blood glucose measurement
- I View the memory for control solution measurement
- (10) Removal of Bluetooth function
The rationales of differences from predicate device:
-
(1) Meter size change:
For product portfolio plan, a smaller size with less cost is offered to customer. -
(2) Ejection button color change: Separate the color of the housing to make the ejection button more easily to be seen.
-
(3) Ejection button position change: Change the ejection button from the lower half of the meter to the upper half, which is a requirement from potential customers.
-
(4) Operation button size change: The three-dimensional raised button design is more noticeable for user to operate.
-
(5) Removal of USB transfer: Simplify the data transfer function of meter.
-
(6) LCD interface change- "Month" and "Day" are displayed in the upper left corner of the LCD screen:
Give the meanings of numbers which are displayed in the upper left corner of the LCD.
- (7) LCD interface change- Remove one display bar in the upper left corner of the LCD screen: Removing this display bar will not affect the date and time display of the instrument and can reduce costs.
- (8) LCD interface change- Remove "AM" in the upper right corner of the LCD screen. Removing "AM" will not affect the date and time display of the meter and can reduce costs.
- (9) User interface change-"Month" and "Day" are displayed on the LCD when user doing:
- Date Setup l
- י Blood Glucose Measurement
- l Control Solution Measurement
- ı View the memory for blood glucose measurement
- I View the memory for control solution measurement
Give the meanings of numbers which are displayed in the upper left corner of the LCD.
- (10) Removal of Bluetooth function:
Simplify the data transfer function of meter.
8
Image /page/8/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 is the tagline "Greater Measure for Life".
♥ 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
し+886-37-585988 을 +886-37-585996
| Predicate Device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100 Blood Glucose Monitoring System | Tyson Bio HS100 Blood Glucose Monitoring System |
| Meter | ||
| Appearance | Image: Tyson Bio HT100 Blood Glucose Monitoring System | Image: Tyson Bio HS100 Blood Glucose Monitoring System |
| Meter Size: | Meter Size: | |
| 106 x 66 x 20 mm (LWH) | 108 x 55 x 15 mm (LWH) | |
| Ejection button Color: | Ejection button Color: | |
| White | Orange | |
| Ejection button position: | Ejection button position: | |
| The lower half of the meter | The upper half of the meter | |
| Three-view drawing: | Three-view drawing: | |
| Image: Three-view drawing of Tyson Bio HT100 Blood Glucose Monitoring System | Image: Three-view drawing of Tyson Bio HS100 Blood Glucose Monitoring System |
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 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, lighter font.
♥ 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
ﺔ +886-37-585988 을 +886-37-585996
Predicate Device (K170079) Proposed Device Item Tyson Bio HT100 Blood Glucose Monitoring System Tyson Bio HS100 Blood Glucose Monitoring System Operating Buttons Front: Front: 3,5 66 ±0.1 $7,15 212 8 16 Side: Side: ുമ്പ് 38.94 5.78 oi റ്റ് Back: Back:
10
Image /page/10/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 sans-serif font. Below the text 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
| Predicate Device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100 Blood Glucose Monitoring System | Tyson Bio HS100 Blood Glucose Monitoring System |
| Image: Predicate Device | Image: Proposed Device | |
| USB Interface | Yes | No |
| LCD Display | Image: Predicate Device LCD Display | Image: Proposed Device LCD Display |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). | ||
| User Interface | Date Setup: | |
| Image: Predicate Device Date Setup | Date Setup: | |
| Image: Proposed Device Date Setup | ||
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| User Interface | Blood Glucose Measurement Display: | |
| Image: Predicate Device Blood Glucose Measurement Display | Blood Glucose Measurement Display: | |
| Image: Proposed Device Blood Glucose Measurement Display | ||
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| Predicate Device (K170079) | Proposed Device | |
| Item | Tyson Bio HT100 Blood Glucose Monitoring System | Tyson Bio HS100 Blood Glucose Monitoring System |
| Control Solution Measurement Display: | Control Solution Measurement Display: | |
| Image: Control Solution Measurement Display for Predicate Device | Image: Control Solution Measurement Display for Proposed Device | |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| Memory Display for Blood Glucose | ||
| Measurement: | Memory Display for Blood Glucose | |
| Measurement: | ||
| Image: Memory Display for Blood Glucose Measurement for Predicate Device | Image: Memory Display for Blood Glucose Measurement for Proposed Device | |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| Memory Display for Control Solution | ||
| Measurement: | Memory Display for Control Solution | |
| Measurement: | ||
| Image: Memory Display for Control Solution Measurement for Predicate Device | Image: Memory Display for Control Solution Measurement for Proposed Device | |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| Bluetooth | Yes | No |
| Predicate device (K170079) | Proposed Device | |
| Item | Tyson Bio HT100-B Blood | |
| Glucose Monitoring System | Tyson Bio HS100-B Blood | |
| Glucose Monitoring System | ||
| Intended Use | Over-The-Counter | |
| Quantitative measurement of glucose (sugar) in fresh capillary | ||
| whole blood samples. | ||
| Enzyme | Electrochemical biosensor with Glucose Dehydrogenase (FAD) | |
| 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 | ||
| Range | 10-40 °C (50-104°F) | |
| Operating Humidity | ||
| Range | 10-90% | |
| Memory Capacity | 500 results with time and date | |
| Bluetooth | Yes |
11
Image /page/11/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 the text is the tagline "Greater Measure for Life."
♥ 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
し+886-37-585988 을 +886-37-585996
12
Image /page/12/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 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.
7 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli Countv 35053. Taiwan +886-37-585996
6.2 Tyson Bio HS100-B Blood Glucose Monitoring System
Similarities:
Differences:
The item list of differences from predicate device:
- (1) Meter size change
- (2) Ejection button color change
- (3) Ejection button position change
- (4) Operation button size change
- (5) Removal of USB transfer:
- (6) LCD interface change- "Month" and "Day" are displayed in the upper left corner of the LCD screen
- (7) LCD interface change- Remove one display bar in the upper left corner of the LCD screen
- (8) LCD interface change- Remove "AM" in the upper right corner of the LCD screen.
- (9) User interface change-"Month" and "Day" are displayed on the LCD when user doing:
- Date Setup l
- ı Blood Glucose Measurement
- Control Solution Measurement
- l View the memory for blood glucose measurement
- I View the memory for control solution measurement
The rationales of differences from predicate device:
13
Image /page/13/Picture/1 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, blue, and green. To the right of the "T" is the text "tyson bio" in a sans-serif font. Below "tyson bio" is the text "Greater Measure for Life" in a smaller, thinner font.
No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township,
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(1) Meter size change:
For product portfolio plan, a smaller size with less cost is offered to customer. -
(2) Ejection button color change: Separate the color of the housing to make the ejection button more easily to be seen.
-
(3)Ejection button position change: Change the ejection button from the lower half of the meter to the upper half, which is a requirement from potential customers.
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(4)Operation button size change: The three-dimensional raised button design is more noticeable for user to operate.
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(5)Removal of USB transfer:
Simplify the data transfer function of meter.
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(6) LCD interface change- "Month" and "Day" are displayed in the upper left corner of the LCD screen:
Give the meanings of numbers which are displayed in the upper left corner of the LCD. -
(7) LCD interface change- Remove one display bar in the upper left corner of the LCD screen: Removing this display bar will not affect the date and time display of the meter and can reduce costs.
-
(8) LCD interface change- Remove "AM" in the upper right corner of the LCD screen.
Removing "AM" will not affect the date and time display of the meter and can reduce costs.
- (9) User interface change-"Month" and "Day" are displayed on the LCD when user doing:
- l Date Setup
- Blood Glucose Measurement
- Control Solution Measurement
- l View the memory for blood glucose measurement
- I View the memory for control solution measurement
Give the meanings of numbers which are displayed in the upper left corner of the LCD.
| Predicate Device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bio HS100-B Blood Glucose Monitoring System |
| Meter Appearance | ||
| Meter Size: | Meter Size: | |
| 106 x 66 x 20 mm (LWH) | 108 x 55 x 15 mm (LWH) |
14
Image /page/14/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 lines: red, green, and blue. To the right of the "T" is the text "tyson bio" in a serif font. Below "tyson bio" is the text "Greater Measure for Life" in a smaller, sans-serif font.
♥ 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
し+886-37-585988 을 +886-37-585996
| Predicate Device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bio HS100-B Blood Glucose Monitoring System |
| Ejection button Color: | Ejection button Color: | |
| White | Orange | |
| Ejection button position: | Ejection button position: | |
| The lower half of the meter | The upper half of the meter | |
| Three-view drawing: | Three-view drawing: | |
| Image: Three-view drawing of the predicate device | Image: Three-view drawing of the proposed device | |
| Operating | ||
| Buttons | Image: Operating buttons of the predicate device | Image: Operating buttons of the proposed device |
| Image: Operating buttons of the predicate device (close up) | Image: Operating buttons of the proposed device (close up) |
15
Image /page/15/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 black, with the words "Greater Measure for Life" in a smaller font size underneath.
� 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
ﺔ +886-37-585988 을 +886-37-585996
Image /page/15/Figure/5 description: The image compares the Tyson Bio HT100-B Blood Glucose Monitoring System with the Tyson Bio HS100-B Blood Glucose Monitoring System. The comparison includes front, side, and back views of each device with dimension labels. The Tyson Bio HT100-B has a USB interface, while the Tyson Bio HS100-B does not.
16
Image /page/16/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 black font, with the words "Greater Measure for Life" in a smaller font below.
♥ 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
し+886-37-585988 을 +886-37-585996
| Predicate Device (K170079) | Proposed Device | |
|---|---|---|
| Item | Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bio HS100-B Blood Glucose Monitoring System |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). | ||
| Date Setup: | ||
| Image: Date setup for predicate device | Date Setup: | |
| Image: Date setup for proposed device | ||
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| User | ||
| Interface | Blood Glucose Measurement Display: | |
| Image: Blood glucose measurement display for predicate device | ||
| Control Solution Measurement Display: | ||
| Image: Control solution measurement display for predicate device | ||
| Memory Display for Blood Glucose | ||
| Measurement: | ||
| Predicate Device (K170079) | Proposed Device | |
| Item | Tyson Bio HT100-B Blood Glucose Monitoring System | Tyson Bio HS100-B Blood Glucose Monitoring System |
| Image: Predicate Device Display | Image: Proposed Device Display | |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. | ||
| Memory Display for Control Solution | ||
| Measurement: | Memory Display for Control Solution | |
| Measurement: | ||
| Image: Predicate Device Memory Display | Image: Proposed Device Memory Display | |
| Circled icons are the difference with respect to | ||
| predicate device (K170079). Indications of | ||
| "Month" and "Day" are applied. |
17
Image /page/17/Picture/0 description: The image is a 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. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
ﺔ +886-37-585988 을 +886-37-585996
7. Conclusion
The Tyson Bio HS100 and HS100-B Blood Glucose Monitoring Systems are substantially equivalent to the predicate device.