The TysonBio AC500 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 AC500 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The TysonBio AC500 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 AC500 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 AC500 Test Strips are for use with the TysonBio AC500 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio AC800 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 AC800 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The TysonBio AC800 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 AC800 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 AC800 contains a voice function but this function is not intended for users with impaired vision.

The TysonBio AC800 Test Strips are for use with the TysonBio AC800 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio AC500 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 AC500 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, auto-disabling lancing devices.

The TysonBio AC500 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 AC500 Pro Blood Glucose Test Strips are for use with the TysonBio AC500 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,

The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio AC800 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 AC800 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, auto-disabling lancing devices.

The TysonBio AC800 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 AC800 Pro contains a voice function but this function is not intended for users with impaired vision.

The TysonBio AC800 Pro Blood Glucose Test Strips are for use with the TysonBio AC800 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

Device Description

The TysonBio AC500/AC800 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 AC500/AC800 Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500/AC800 Blood Glucose Monitoring System.

The TysonBio AC500 Pro/AC800 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 AC500 Pro/AC800 Pro Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500 Pro/AC800 Pro Blood Glucose Monitoring System.

The TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of:
a. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Meter
b. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Test Strips
c. TysonBio AC500/AC800 Control Solution

AI/ML Overview

The provided text is a 510(k) summary for the TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring Systems. While it establishes the substantial equivalence of the proposed device to a predicate device and states that "The studies demonstrated that the performance of this system meets its intended use," it does not contain specific acceptance criteria, detailed study results, or information about the methodology (like sample sizes, ground truth establishment, or expert involvement) that would be expected for a comprehensive description of acceptance criteria and a study proving device performance in the context of human-in-the-loop AI or standalone imaging algorithms.

The document primarily focuses on:

Device Description and Intended Use: Explaining what the glucose meters are and what they are used for.
Predicate Device Comparison: Highlighting similarities and differences with a previously cleared device (TysonBio AC100). The most significant difference noted is the hematocrit range.
Regulatory Conclusion: Stating that the device is substantially equivalent to the predicate.

Therefore, many of the requested details cannot be extracted from the provided text. The term "acceptance criteria" is not explicitly defined in terms of specific performance thresholds (e.g., accuracy percentages for different glucose ranges). The study mentioned is broadly described as having been conducted "in the laboratory and in clinical settings by healthcare professionals and lay users," but specifics are missing.

Here's an attempt to answer based only on the provided text, with significant acknowledgment of missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical table. It only provides a general statement: "The studies demonstrated that the performance of this system meets its intended use."

2. Sample sized 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 specified.
Data Provenance: Not specified (country of origin, retrospective/prospective). The studies were conducted "in the laboratory and in clinical settings."

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)

Not applicable/Not specified. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method (e.g., YSI or hexokinase method) rather than human expert consensus, as is common for imaging AI. The document does not detail how the ground truth reference values were obtained.

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

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists) where disagreements in ground truth labeling need resolution. This is not mentioned for this type of device.

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

Not applicable. This device is a blood glucose meter, not an AI assisting human readers in diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant to this product.

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

The device itself is a standalone algorithm (a blood glucose meter that provides a numerical reading). The "performance characteristic summary" states that the performance was studied "in the laboratory and in clinical settings by healthcare professionals and lay users." This implies that the device's output (glucose reading) was evaluated in these settings, which equates to a standalone performance evaluation.

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

Not explicitly stated. For blood glucose meters, the ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). The document does not specify the method used as the reference.

8. The sample size for the training set

Not applicable/Not specified. This document pertains to a traditional medical device (blood glucose meter) and its submission for regulatory clearance. It does not describe an AI/ML model that would typically have a separate "training set." The performance evaluation mentioned (laboratory and clinical settings) refers to validation of the final device, not the training of an underlying algorithm in the AI/ML sense.

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

Not applicable. As noted above, this context of "training set" and its ground truth establishment is not relevant to the information provided for this traditional medical device.

Summary

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510(k) SUMMARY

JUN 1 8 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Date prepared May 8, 2013

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 EXT 720 Facsimile: 886-37-585996

3. Device name and classification

Device Name:

TysonBio AC500 Blood Glucose Monitoring System TysonBio AC800 Blood Glucose Monitoring System TysonBio AC500 Pro Blood Glucose Monitoring System TysonBio AC800 Pro Blood Glucose Monitoring System TysonBio AC500/AC800 Control Solution TysonBio AC500 Test Strip TysonBio AC800 Test Strip TysonBio AC500 Pro Test Strip TysonBio AC800 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:

NBW- System, Test, Blood Glucose, Over-the-counter

CGA - Glucose Oxidase, Glucose

JJX Single (specified) analyte controls (assayed and unassayed)
Panel Clinical Chemistry and Toxicology

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4. Device description

The TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of:

a. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Meter
b. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Test Strips
c. TysonBio AC500/AC800 Control Solution

5. Intended use

TysonBio AC500 Blood Glucose Monitoring System :

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TysonBio AC800 Blood Glucose Monitoring System :

TysonBio AC500 Pro Blood Glucose Monitoring System :

The TysonBio AC500 Pro Blood Glucose Test Strips are for use with the TysonBio AC500 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

TysonBio AC800 Pro Blood Glucose Monitoring System :

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effectiveness of diabetes control program. This system should only be used with single-use lancing devices.

The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 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 oxidase. There has been no change to the fundamental scientific technology.

7. Predicate device

TysonBio AC100 Blood Glucose Monitoring System (K101543)

	Proposed Device		Predicate Device
Item	TysonBio AC500	TysonBio AC800	TysonBio AC100
Meter appearance	Image: TysonBio AC500 meter	Image: TysonBio AC800 meter	Image: TysonBio AC100 meter
Backlight	NA	Selectable backlighton/off by user	NA
Voice guidance	NA	Selectable on/offvoice guidance	IDENTICAL
Hematocrit range	20~60%	20~60%	35-55%
Meal flag	Apple	Apple	Hamburger

Difference:

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Image /page/4/Picture/0 description: The image shows three digital displays, likely from a medical device such as a glucose meter. The first two displays show similar readings with the time as 88-88 and a value of 88.8 mg/dL. The third display shows a similar time, but the value is 888 mg/dL.

Similarities:

	Proposed Device		Predicate Device
Item	TysonBio AC500	TysonBio AC800	TysonBio AC100
Test principle	Electrochemicalbiosensor withglucose oxidase.	IDENTICAL	IDENTICAL
Blood sample	Fingertip, palm andforearm	IDENTICAL	IDENTICAL
Sample volume	0.5uL	IDENTICAL	IDENTICAL
Test time	5 seconds	IDENTICAL	IDENTICAL
Detecting range	20 ~ 600 mg/dL	IDENTICAL	IDENTICAL
Unit of measurement	mg/dL or mmol/L	IDENTICAL	IDENTICAL
Coding	Auto coding byinserting the test strip	IDENTICAL	IDENTICAL
Operating temperature	10 to 40 °C (50-104°F)	IDENTICAL	IDENTICAL
Operating humidity	10 to 90%	IDENTICAL	IDENTICAL
Average result	7,14, 30 days premeal and post mealtest average	IDENTICAL	IDENTICAL
Hypoglycemic andhyperglycemic alarm	2 user setting alarms	IDENTICAL	IDENTICAL
Reminder alarm	4 user setting alarms	IDENTICAL	IDENTICAL
PC link Protocol	USB protocol	IDENTICAL	IDENTICAL
Control solution	3 Levels available	IDENTICAL	IDENTICAL
Strip storagetemperature	4 to 30 °C (40-86°F)	IDENTICAL	IDENTICAL
Memory capacity	500 test resultmemories	IDENTICAL	IDENTICAL
Supply power	Two AAA batteries	IDENTICAL	IDENTICAL
Button	Three operatingbutton (M, up anddown)One ejection button	IDENTICAL	IDENTICAL

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The hematocrit range of proposed devices is 20%~60% by sensing voltage and algorithm change from predicted device.

8. Performance characteristic summary

The performance of TysonBio AC500/AC800/AC500 Pro/AC800 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 AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring System is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2013

Tyson Bioresearch. Inc. C/O Wen-Hai Tsai, Ph.D. 5F., #22, Ke E.Road III., Science-Based Industrial Park CHUN-NAN, MIAO-LI COUNTY, TAIWAN, R.O.C. 350

Re: K123087

Trade/Device Name: TysonBio AC500 Blood Glucose Monitoring System TysonBio AC800 Blood Glucose Monitoring System Tyson Bio AC500 Pro Blood Glucose Monitoring System TysonBio AC800 Pro Blood Glucose monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: May 18, 2013

Received: May 23, 2013

Dear Dr. 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.off 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -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

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Indications for Use Form

510(k) Number (if known): K123087

Device Name: TysonBio AC500 Blood Glucose Monitoring System

Indications for Use:

AND/OR Over-The-Counter Use X Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) '

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OIR)

Katherine /Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

510(k) K123087

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Indications for Use Form

510(k) Number (if known): K123087

Device Name: TysonBio AC800 Blood Glucose Monitoring System

Indications for Use:

Prescription Use	AND/OR Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)	(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OlR)

Katherine //Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

Page 2 of 4

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510(k) K123087

Indications for Use Form

510(k) Number (if known): K123087

Device Name: TysonBio AC500 Pro Blood Glucose Monitoring System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use X_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OIR)

Katherine /Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

Page 3 of 4

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510(k) K123087

Indications for Use Form

510(k) Number (if known): K123087

Device Name: TysonBio AC800 Pro Blood Glucose Monitoring System

Indications for Use:

AND/OR Over-The-Counter Use X Prescription Use X (21 CFR 801 Subpart C) . (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

510(k) K123087

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.