TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 by TYSON BIORESEARCH, INC.

The TysonBio AC100 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC100 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 AC100 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 AC100 contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 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 single-use lancing devices. The TysonBio AC100 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 AC100 Pro contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC200 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 AC200 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 AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 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 single-use lancing devices. The TysonBio AC200 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 AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System is an amperometric biosensor, It is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System consist of three main products: the meter, Test Strips and Control Solutions. Use only TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use i TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.

AI/ML Overview

The provided text describes the TysonBio AC100/AC200 Blood Glucose Monitoring Systems and their substantial equivalence to a predicate device, the Easy Step Blood Glucose Monitoring System (K090629). However, it does not explicitly state specific acceptance criteria (e.g., accuracy percentages within certain glucose ranges) or detailed performance metrics against those criteria. The document only broadly states that "The studies showed substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System." and "Evaluations...were studied in the laboratory and in a clinical setting using persons with diabetes. The results were compared to results from the currently marketed Easy Step Blood Glucose Monitoring System and to a laboratory method."

Therefore, based on the provided text, I cannot complete all sections of your request with specific numbers.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the provided text.)	"Substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System."
(Likely involved accuracy metrics within glucose ranges, as is standard for BGMs, but specific percentages are not given.)	Compared favorably to a laboratory method and the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "a clinical setting using persons with diabetes" but doesn't provide the number of participants.
Data Provenance: Not explicitly stated. The sponsor information indicates Tyson Bioresearch, Inc. is in Taiwan, but it doesn't specify where the clinical evaluation was conducted. The study appears to be prospective due to the nature of clinical evaluations for new medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not applicable or not stated. For blood glucose monitoring systems, the "ground truth" is typically established by a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images or clinical assessments.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This method is typically used for image-based or qualitative assessments where multiple human readers might disagree. For blood glucose measurements, the reference method provides a quantitative value.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is not relevant for a blood glucose monitoring system, which is a standalone diagnostic device. The study evaluates the device's accuracy against a reference method and a predicate device, not its impact on human reader performance.
Effect Size of Human Readers with AI: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes. The performance evaluation was for the device itself (meter and test strips) in measuring glucose. This is by nature a standalone performance evaluation, comparing its results to a laboratory reference method. The "human-in-the-loop" aspect for a blood glucose monitor primarily refers to the user taking the sample and operating the device, but the measurement mechanism is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: A "laboratory method" was used, often a highly accurate and precise analytical instrument like a YSI Glucose Analyzer, which serves as the reference standard for glucose concentration.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not stated. Blood glucose monitoring systems are typically developed through engineering and chemical optimization, and then validated. They don't typically involve "training sets" in the same way machine learning algorithms do. While there would have been internal R&D and calibration data, it's not described as a "training set" in this context.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable. As mentioned above, the concept of a "training set" with established ground truth is not directly relevant to the described development and validation of this type of medical device in the same way it would be for an AI/ML device. The device's calibration and accuracy are established through comparison to precise laboratory methods during development and validation.

Summary

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K101543

510(k) SUMMARY

AUG 3 0 2011

Date prepared August 28, 2011

2. 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 Facsimile: 886-37-585996

3. Device name and classification

Device Name:

TysonBio AC100 Blood Glucose Monitoring System TysonBio AC100 Pro Blood Glucose Monitoring System TysonBio AC200 Blood Glucose Monitoring System TysonBio AC200 Pro Blood Glucose Monitoring System

Common Names: Blood Glucose Monitoring System

Classification: Classification: Class II Classification Regulation: 21 CFR 862.1345 Product Code: CGA (Glucose Oxidase, Glucose) NBW (System, Test, Blood Glucose, Over The Counter) Panel - Clinical Chemistry and Toxicology

4. Device description

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TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use i TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.

5. Intended use

TysonBio AC100 Blood Glucose Monitoring System:

The TysonBio AC100 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 AC100 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 AC100 contains a voice function but this function is not intended for users with impaired vision.

The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

TysonBio AC100 Pro Blood Glucose Monitoring System:

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changing rapidly). The TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision.

The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

TysonBio AC200 Blood Glucose Monitoring System:

The TysonBio AC200 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 AC200 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 AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

TysonBio AC200 Pro Blood Glucose Monitoring System:

The TysonBio AC200 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 AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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6. Test principle

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

7. Predicate device

Easy Step Blood Glucose Monitoring System (K090629)

Comparison to predicate device

The modifications to the device encompass:

Addition of selectable voice guidance on/off function (for TysonBio AC100 model only)
· Addition of hypoglycemic and hypoglycemic alarm setting
· Removal of backlight
· Extension of meter memory capacities
· Changes in outer case appearance
· Change to auto coding.

There have been no changes to the operating principle, intended use or functionality.

8. Performance characteristic summary

Evaluations of the TysonBio AC100 / A100 Pro Blood Glucose Monitoring System and the TysonBio AC200 / AC200 Pro Blood Glucose Monitoring System were studied in the laboratory and in a clinical setting using persons with diabetes. The results were compared to results from the currently marketed Easy Step Blood Glucose Monitoring System and to a laboratory method. The studies showed substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System.

9. Conclusion

The TysonBio AC100 / AC200 Blood Glucose Monitoring System is substantially equivalent to the predicate Easy Step Blood Glucose Monitoring System.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with healthcare, with three horizontal lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Tyson Bioresearch Inc. c/o Wen-Hai Tsai 5F, #22, Ke E. Road III, Science-Based Industrial Park Chun-Nan, Miao-Li County China (Taiwan) 350

AUG 3 0 2011

Re: K101543 TysonBio AC100/AC100Pro/AC200Pro Blood Glucose Monitoring System Trade/Device Name: Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: 'July 21, 2011 Received: August 25, 2011

Dear Mr. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum 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/McdicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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510(k) Number (if known): K101543

Device Name: TysonBio AC100 Pro Blood Glucose Monitoring System

Indication for Use:

The TysonBio AC100 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 AC100 Pro contains a voice function but this function is not intended for users with impaired vision.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or Over the Counter Use _ × (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 Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KIO1543

off

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510(k) Number (if known): _

Device Name: TysonBio AC100 Blood Glucose Monitoring System

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or Over the Counter Use (21 CFR Part 801 Subpart D) (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 Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TysonBio AC200 Pro Blood Glucose Monitoring System

Indication for Use:

And/Or Over the Counter Use __ × Prescription Use (21 CFR Part 801 Subpart D) (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 Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

KIDI543 510(k)________________________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known):

Device Name: TysonBio AC200 Blood Glucose Monitoring System

Indication for Use:

· The TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
And/Or Over the Counter Use ___X Prescription Use (21 CFR Part 801 Subpart D) (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 Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)

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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.