(323 days)
Not Found
No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is a blood glucose monitoring system, intended to measure glucose levels and aid in monitoring the effectiveness of diabetes control, not to provide therapy itself.
No.
The "Intended Use / Indications for Use" section explicitly states "The TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use" and "The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use."
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are all hardware components.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the TysonBio MD100 and the TysonBio MD100 Pro explicitly states: "The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use)..." and "The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)...".
- Nature of the Test: The system measures glucose in blood samples, which is a test performed on a biological sample outside the body to provide information about a person's health status. This is the fundamental definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NBW, JJX
Device Description
The TysonBio MD100 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System.
The TysonBio MD100 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System.
The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of:
- a. TysonBio MD100/MD100 Pro Blood Glucose Meter
- TysonBio MD100/MD100 Pro Test Strips b.
- TysonBio MD100 Control Solution
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm, forearm
Indicated Patient Age Range
Not Found (explicitly states "should not be used for ... neonatal use.")
Intended User / Care Setting
Home (single person) for TysonBio MD100 Blood Glucose Monitoring System; professional healthcare settings (multiple-patient use) for TysonBio MD100 Pro Blood Glucose Monitoring System.
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)
The performance of TysonBio MD100 / TysonBio MD100 Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
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
K 112916
Image /page/0/Picture/1 description: The image shows the logo for TysonBio. The logo is black and white and features the word "Tyson" in bold, sans-serif font. The word "Bio" is attached to the end of Tyson and is surrounded by a circular design with two dots. The logo is simple and modern.
YSON BIORESEARCH, INC #22 Ke F Road III Science-Based Industrial Park aiwan, R.O.C. Postal Code: 350 Website: www.tys 01 +886-37-585988 86-37-585996
510(k) SUMMARY
AUG 2 1 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
-
- Date prepared August 20, 2012
-
- Sponsor information
Tyson Bioresearch, Inc.
5 F., # 22, Ke E. Road III., science based industrial park Chun-Nan, Miao-Li county, Taiwan 350
Correspondent:
WEN-HAI TSAI
Phone: 886-37-585988 EXT 720 Facsimile: 886-37-585996
3. Device name and classification
Device Name:
TysonBio MD100 Blood Glucose Monitoring System TysonBio MD100 Pro Blood Glucose Monitoring System TysonBio MD100 Control Solution TysonBio MD100 Test Strip TysonBio MD100 Pro Test Strip
Common Names:
Blood Glucose Monitoring System
Classification:
Classification Regulation: 21 CFR 862.1345 and 21CFR 862.1660
Classification: Class II (Glucose Test System)
Class I (Quality control material )
Product Code: LFR (Glucose Dehydrogenase, Glucose)
NBW (System, Test, Blood Glucose, Over The Counter)
- JJX, Single (specified) analyte controls (assayed and unassayed)
Panel - Clinical Chemistry and Toxicology
1
Image /page/1/Picture/0 description: The image shows the logo for TysonBio. The logo is black and white and features the word "TysonBio" in a bold, sans-serif font. A curved line extends over the top of the word "TysonBio" and circles around the letters. The logo is simple and modern.
TYSON BIORESEARCH. INC. 5F. #22, Ke E. Road III Science-Based Industrial Park, Chu-Nan, Taiwan, R.O.C. Postal Code: 350 Website: www.tysonbjo.com Ol +886-37-585988
4. Device description
The TysonBio MD100 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System.
The TysonBio MD100 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System.
The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of:
- a. TysonBio MD100/MD100 Pro Blood Glucose Meter
- TysonBio MD100/MD100 Pro Test Strips b.
- TysonBio MD100 Control Solution
5. Intended use
TysonBio MD100 Blood Glucose Monitoring System :
The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure qlucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
2
Image /page/2/Picture/0 description: The image shows the logo for TysonBio. The logo is black and features the word "TysonBio" in a bold, sans-serif font. The "o" in "Tyson" and the "o" in "Bio" are stylized as circles, and a curved line connects the two circles, creating a visual link between the two parts of the name. The overall design is simple and modern.
TYSON BIORESEARCH. INC. 5F. #22, Ke E. Road III Science-Based Industrial Park, Chu-Nan; Taiwan, R.O.C. Postal Code: 350 Website: www.tysonbio.com O] +886-37-585988 F1 +886-37-585996
TysonBio MD100 Pro Blood Glucose Monitoring System :
The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alfernative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
6. Test principle
The test principle is based on electrochemical biosensor technology using glucose dehydrogenase. There has been no change to the fundamental scientific technology.
7. Predicate device
| Item | Predicate Device (K062058) | Proposed Device |
|---|---|---|
| Ascensia Contour | ||
| Blood Glucose Monitoring System | TysonBio MD100 /MD100 Pro | |
| Blood Glucose Monitoring System | ||
| Meter size | 77 mm (H) x 57 mm (W) x 19 mm (T) | 94 mm (H) x 63 mm (W) x 25 mm (T) |
| Meter weight | 47.5 grams | 60 grams without battery |
| Sample volume | 0.6uL | 0.5uL |
| AST | Palm, forearm and heel (neonates) | Palm and forearm |
| Measuring Range | 10-600mg/dL | 20-600mg/dL |
| Hematocrit range | 0~70 % | 10-70% |
| Operating | ||
| Temperature | ||
| Range: | 5 to 45 degrees C (41-113°F) | 10 to 40 degrees C (50-104°F) |
| Humidity | 10-93% | 10-90% |
| Memory Feature | Stores most recent 480 test results | Stores most recent 500 test results |
| Battery Type: | Two 3-volt lithium batteries | |
| (DL2032 or CR2032) | Two AAA batteries | |
| Battery Life: | Approximately 1000 tests | |
| (1 yr. average use) | Approximately 1000 tests | |
| Marker | Meal and log book | Meal |
| Reminder alarm | Post-Meal Test Alarm | 4 user setting alarms |
| Button | Three operating button | |
| (M, up and down) | Three operating button | |
| (M, up and down) | ||
| One ejection button |
Ascensia CONTOUR Blood Glucose Monitoring System (K062058)
3
Image /page/3/Picture/0 description: The image shows the logo for TysonBio. The logo is in black and white, with the word "Tyson" in bold letters. The word "Bio" is also in bold letters and is connected to the word "Tyson" by a curved line that forms a circle around the letters "sonBi".
TYSON BIORESEARCH, INC.
5F. #22, Ke E. Road III Science-Based Industrial Park, Chu-Nan, Taiwan, R.O.C. Postal Code: 350 Website: www.tysonbio.com 0] +886-37-585988 F1 +886-37-585996
Similarities:
| Item | Predicate Device (K062058) | Proposed Device |
|---|---|---|
| Ascensia Contour | ||
| Blood Glucose Monitoring System | TysonBio MD100 / MD100 Pro | |
| Blood Glucose Monitoring System | ||
| Test principle | Electrochemical biosensor with | |
| glucose dehydrogenase (FAD) | Electrochemical biosensor with glucose | |
| dehydrogenase (FAD) | ||
| Test Sample | Whole blood | |
| (Capillary and venous blood) | Whole blood | |
| (Capillary and venous blood) | ||
| Measuring | ||
| Time | 5 seconds | 5 seconds |
| Coding | Auto coding by inserting the test strip | Auto coding by inserting the test strip |
| Hypoglycemic | ||
| and | ||
| hyperglycemic | ||
| alarm | 2 user setting alarms | 2 user setting alarms |
| Average result | 7,14 and 30days | 7,14 and 30days |
8. Performance characteristic summary
The performance of TysonBio MD100 / TysonBio MD100 Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
9. Conclusion
The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized feathers. The symbol is black and appears to be in motion.
Tyson Bioresearch, Inc. c/o Wen-Hai Tsai 5 F., #22, Ke E. Road III, Science-Based Industrial Park Chu-Nan, Miao-Li County China (Taiwan) 350
10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 2 1 2012
Re: K112916
Trade Name: TysonBio MD100 Blood Glucose Monitoring System TysonBio MD100 Pro Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: August 9, 2012 Received: August 13, 2012
Dear Wen-Hai Tsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: TysonBio MD100 Pro Blood Glucose Monitoring System
Indication for Use:
The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
X Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Raul Luus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112916
Page 1 of 2
7
Indication for Use
510(k) Number (if known):
Device Name: TysonBio MD100 Blood Glucose Monitoring System
Indication for Use:
The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
Prescription Use _ (21 CFR Part 801 Subpart D) And/Or Over the Counter Use x (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112916
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