A.) Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Description

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3) and single-use lancing devices. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose level presented in the sample, providing a quantitative measure of glucose level in whole blood.

AI/ML Overview

This 510(k) summary provides limited information regarding the performance studies. Therefore, a comprehensive description of acceptance criteria and the entire study that proves the device meets those criteria cannot be fully extracted.

However, based on the provided text, here's what can be gathered and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that both the Glucose Shepherd Blood Glucose Monitoring System and the Glucose Shepherd Pro Blood Glucose Monitoring System were studied in laboratory and clinical settings, and these studies "have demonstrated that this system meets the performance requirements of its intended use."

While explicit numerical acceptance criteria are not detailed in this summary, in the context of blood glucose monitoring systems, "performance requirements" typically refer to accuracy standards. For example, ISO 15197 (In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus) is a commonly referenced standard. A key part of this standard's accuracy requirement is that a certain percentage of results (e.g., 95%) must fall within a defined range of a reference method (e.g., within ±15 mg/dL for glucose concentrations <100 mg/dL and within ±15% for glucose concentrations ≥100 mg/dL).

Given the submission is for a 510(k), the device must demonstrate substantial equivalence to a predicate device. This implies that its performance (including accuracy) is at least as good as, if not better than, the predicate. Therefore, the "reported device performance" is essentially that the device meets relevant accuracy standards and is substantially equivalent to the predicate device.

Since no specific numerical acceptance criteria or detailed performance data are provided in the summary, we can only state the general claim.

Acceptance Criteria (Inferred from "Performance Requirements")	Reported Device Performance
Meet performance requirements of intended use (e.g., accuracy standards like ISO 15197)	Demonstrated to meet performance requirements in laboratory and clinical settings.
Substantial equivalence to predicate device	Achieved substantial equivalence to the predicate device (Advocate Redi-Code Blood Glucose Monitoring System, K072039).

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "clinical settings" and "clinical testing results" but does not specify:

The exact sample size for the test set.
The country of origin of the data.
Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than reliance on human expert consensus, so the concept of "experts establishing ground truth" as it applies to image-based diagnostic systems might not be directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, often in imaging or subjective diagnostic tasks. For objective measurements like blood glucose, adjudication would refer to how discrepancies between the device and the reference method or across multiple device measurements were handled, which is not detailed here.

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

No, an MRMC comparative effectiveness study was not done.
This type of study is not relevant for a blood glucose monitoring system, which is a quantitative measurement device rather than an AI-driven image interpretation or diagnostic system that assists human readers.

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

A standalone performance study was done.
The entire premise of a blood glucose monitoring system is its standalone performance (the meter and test strip system providing a direct quantitative measurement). The document states, "The performance... was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use." This confirms a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established by a highly accurate laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated in the summary, this is the standard practice for evaluating such devices. The document refers to "laboratory testing results" which would involve comparison against such a reference.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. For a blood glucose monitoring system based on an amperometric method, the "training set" concept (as used in machine learning) is generally not directly applicable. The device's calibration and algorithm are developed through engineering and chemical principles, then validated through testing. If the question refers to the samples used to establish the initial calibration curve or internal algorithms, that detail is not disclosed.

9. How the Ground Truth for the Training Set was Established

As mentioned in point 8, the concept of a "training set" for ground truth (in the machine learning sense) is not directly applicable to this type of device. The accuracy of the device's measurement is established through rigorous internal development and external validation against highly precise laboratory reference instruments, which would serve as the "ground truth" for evaluating the system's accuracy. These reference instruments are themselves calibrated and maintained according to strict laboratory standards.

Summary

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510k Summary for A.) Glucose Shepherd Blood Glucose Monitoring System and B.) Glucose Shepherd Pro Blood Glucose Monitoring System

OCT - 7 2011

510(k) Summary (Per 21 CFR 807.92)

	1. Submitter Information
	Company Name	BroadMaster Biotech Corporation
	Address	7F, No. 168-2, Liancheng Rd., Zhonghe CityTaipei County 23553, Taiwan
	Contact Person	Roger Lai
	Phone	886-987-111105/886-2-66375859
	Fax	886-2-22428332
	Email	roger@broadmaster-biotech.com
	Date Prepared	2010/8/13
	2. Device Name
	Proprietary Name	A.)Glucose Shepherd Blood GlucoseMonitoring SystemandB.) Glucose Shepherd Pro Blood GlucoseMonitoring System
	Common Name	Blood Glucose Test System
	Classification Number	System, Test, Blood Glucose, Over theCounter
	Classification Panel	Chemistry
	Product Code	NBW, CGA
	Regulation Number	862.1345
	3. Predicate Device
	Proprietary Name	Advocate Redi-Code Blood GlucoseMonitoring System
	Common Name	Blood Glucose Test System
	Manufacturer	Taidoc Technology Corporation
	510(k) Number	K072039

4. Device Description

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a

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blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

Intended Use

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

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finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Similarities
Item	Glucose Shepherd BloodGlucose Monitoring System(Proposed device)	Advocate Redi-Code BloodGlucose Monitoring System(Predicate device)
Enzyme	Glucose Oxidase	Same
Measurementprinciple	Amperometric method	Same
Intended use	Glucose Shepherd BloodGlucose Monitoring System isintended for use outside thebody (in vitro diagnostic use) athome. It is used forquantitative measurement ofglucose level in fresh capillarywhole blood samples (from the	The Advocate Redi-CodeBlood Glucose MonitoringSystem is intended for use inthe quantitative measurementof glucose in fresh capillarywhole blood from the fingerand the following alternativesites: the palm, the forearm,
finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.	the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.
The Glucose Shepherd Control Solutions are for use with the
Glucose Shepherd BloodGlucose Monitoring System asa quality control check to verifythe accuracy of blood glucosetest results.
Sample type	Fresh capillary whole blood	Same
Coding	No	Same
Power	Two 1.5V AAA alkalinebatteries	Same
Alternate sitecapability	Yes	Same
Hematocritrange	20-60%	Same
Operatingcondition	50°F ~ 104°F (10°C ~ 40°C),below 85% R.H.	Same
Strip storagecondition	39.2°F ~ 104°F (4°C ~ 40°C),below 85% R.H.	Same
PC link	Yes	Same
Differences
Weight	53g	69.87g
Dimensions	64mmx95mmx29mm	96mm(L)x20mm(W)x45mm(H)
Test time	5 seconds	7 seconds
Test volume	1.1µL	0.7µL
Memory	400 measurements withoptional before/after meal flags	450 measurements with dayand time
Test Range	20-600 mg/dL	20-600 mg/dL
Glucoseunits	mg/dL	Either mg/dL or mmol/L
Alarms	6	No
Pre-meal andPost-mealflags	Yes	No
B.)
Similarities
Item	Glucose Shepherd Pro Blood	Advocate Redi-Code Blood

5. Comparison to Predicate Device

A.)

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Similarities
Item	Glucose Shepherd Pro Blood	Advocate Redi-Code Blood
	Glucose Monitoring System(Proposed device)	Glucose Monitoring System(Predicate device)
Enzyme	Glucose Oxidase	Same
Measurementprinciple	Amperometric method	Same
Intended use	Glucose Shepherd Pro BloodGlucose Monitoring System isintended for use outside thebody (in vitro diagnosticuse). It is used for quantitativemeasurement of glucose levelin fresh capillary whole bloodsamples (from the finger, thepalm, the forearm, the upperarm, the calf and thethigh). The alternative sitetesting can be only used duringsteady-state blood glucosemonitoring. The GlucoseShepherd Pro Blood GlucoseMonitoring System may beused for multiple patients in aprofessional healthcaresetting. It is intended for useas an aid in monitoring theeffectiveness of diabetescontrol program. This systemis only used with single-use,auto-disabling lancingdevices. It should not be usedfor the diagnosis or screeningof diabetes, for the testing ofneonates, or for testing ofarterial blood.The Glucose Shepherd ProBlood Glucose MonitoringSystem consists of the	The Advocate Redi-CodeBlood Glucose MonitoringSystem is intended for use inthe quantitative measurementof glucose in fresh capillarywhole blood from the fingerand the following alternativesites: the palm, the forearm,the upper-arm, the calf and thethigh. It is intended for use byhealthcare professionals andpeople with diabetes mellitus athome as an aid in monitoringthe effectiveness of diabetescontrol program. It is notintended for the diagnosis of orscreening for diabetes mellitus,and is not intended for use onneonates.
Weight	53g	69.87g
Differences
PC link	Yes	Same
condition	below 85% R.H.
Strip storage	39.2°F ~ 104°F (4°C ~ 40°C),	Same
condition	below 85% R.H.
Operating	50°F ~ 104°F (10°C ~ 40°C),	Same
range
Hematocrit	20-60%	Same
capability
Alternate site	Yes	Same
	batteries
Power	Two 1.5V AAA alkaline	Same
Coding	No	Same
Sample type	Fresh capillary whole blood	Same
	blood glucose test results.
	check to verify the accuracy of
	System as a quality control
	Pro Blood Glucose Monitoring
	with the Glucose Shepherd
	control solutions are for use
	The Glucose Shepherd Pro

	thigh.
	upper arm, the calf and the
	tips, the palm, the forearm, the
	samples drawn from finger
	in fresh capillary whole blood
	quantitatively measure glucose
	Blood Glucose test strips to
	with Glucose Shepherd Pro
	Glucose meter is used only
	Glucose test strips. TheGlucose Shepherd Pro Blood
	Glucose Shepherd Pro Blood
	Glucose meter and the
	Glucose Shepherd Pro Blood

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{7}------------------------------------------------

Dimensions	64mmx95mmx29mm	96mm(L)x20mm(W)x45mm(H)
Test time	5 seconds	7 seconds
Test volume	1.1µL	0.7µL
Memory	400 measurements withoptional before/after meal flags	450 measurements with dayand time
	Test Range	20-600 mg/dL
Glucoseunits	mg/dL	Either mg/dL or mmol/L
	Alarms	6
Pre-meal andPost-mealflags	Yes	No

6. Performance Studies

A.) The performance of the Glucose Shepherd Blood Glucose Monitoring System was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use.

B.> The performance of the Glucose Shepherd Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use.

7. Conclusion

A.) The laboratory testing results, clinical testing results and labeling of Glucose Shepherd Blood Glucose Monitoring System matches the Indications for Use and support the claim of substantial equivalence to the predicate.

B.) The laboratory testing results, clinical testing results and labeling of Glucose Shepherd Pro Blood Glucose Monitoring System matches the Indications for Use and support the claim of substantial equivalence to the predicate.

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Image /page/8/Picture/0 description: The image shows a circular seal with the words "U.S. Department of Health & Human Services" written around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings. The image is black and white and appears to be a scan or photocopy of an official document.

DEPARTMENT OF HEALTH & HUMAN SERVICES

BroadMaster Biotech Corporation c/o Roger Lai Regulatory Affairs Manager 7F, No. 168-2, Liancheng Rd., Zhonghe City Taipei County 23553. Taiwan

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

OCT - 7 2011

Re: K102316

Trade/Device Name: Glucose Shepherd Blood Glucose Monitoring System Glucose Shepherd Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Clucose Test System Regulatory Class: Class II, Class I, reserved Product Code: NBW, CGA, JJX Dated: September 28, 2011 Received: September 30, 2011

Dear Mr. Lai:

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 class II (Special Controls), 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). 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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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/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 ( 30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Indications for Use Form

510(k) Number (if known): K102316

Device Name: Glucose Shepherd Blood Glucose Monitoring System

Indications for Use:

Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the caff and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ X AND/OR (21 CFR 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)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 1023/L

Page 1 of 2

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Indications for Use Form

510(k) Number (if known): K102316

Device Name: Glucose Shepherd Pro Blood Glucose Monitoring System

Indications for Use:

Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. It is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 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 1102316 510(k) __

Page 2 of 2

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.