Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the amperometric method for glucose measurement and does not mention any AI/ML components or data processing beyond the direct measurement.

Therapeutic

No
The device is a blood glucose monitoring system, used for quantitative measurement of glucose levels as an aid in monitoring the effectiveness of a diabetes control program. It does not provide therapy.

Diagnostic

Yes
The device is intended for the quantitative measurement of glucose levels, which aids in monitoring the effectiveness of a diabetes control program. While it explicitly states it should not be used for diagnosis or screening of diabetes, the act of monitoring glucose levels is a form of diagnostic measurement, providing insights into a patient's physiological state related to their condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a blood glucose meter, test strips, control solutions, and lancing devices, which are all hardware components.

IVD (In Vitro Diagnostic)

Yes, both devices are IVDs (In Vitro Diagnostics).

The intended use statements for both the Glucose Shepherd Blood Glucose Monitoring System and the Glucose Shepherd Pro Blood Glucose Monitoring System explicitly state:

"is intended for use outside the body (in vitro diagnostic use)"

This phrase is the defining characteristic of an In Vitro Diagnostic device. They are designed to perform tests on samples taken from the human body (in this case, blood) to provide information about a person's health status.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. 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 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.

Product codes (comma separated list FDA assigned to the subject device)

NBW, CGA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger, the palm, the forearm, the upper arm, the calf and the thigh

Indicated Patient Age Range

Not Found

Intended User / Care Setting

A.) 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.

B.) The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting.

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)

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.

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.

K072039

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

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.

Summary

0

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 City
Taipei 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 Glucose
Monitoring System
and
B.) Glucose Shepherd Pro Blood Glucose
Monitoring System
	Common Name	Blood Glucose Test System
	Classification Number	System, Test, Blood Glucose, Over the
Counter
	Classification Panel	Chemistry
	Product Code	NBW, CGA
	Regulation Number	862.1345
	3. Predicate Device
	Proprietary Name	Advocate Redi-Code Blood Glucose
Monitoring 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

1

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.

Intended Use

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

2

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.

Similarities
Item	Glucose Shepherd Blood
Glucose Monitoring System
(Proposed device)	Advocate Redi-Code Blood
Glucose Monitoring System
(Predicate device)
Enzyme	Glucose Oxidase	Same
Measurement
principle	Amperometric method	Same
Intended 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	The Advocate Redi-Code
Blood Glucose Monitoring
System is intended for use in
the quantitative measurement
of glucose in fresh capillary
whole blood from the finger
and the following alternative
sites: 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 Blood
Glucose Monitoring System as
a quality control check to verify
the accuracy of blood glucose
test results.
Sample type	Fresh capillary whole blood	Same
Coding	No	Same
Power	Two 1.5V AAA alkaline
batteries	Same
Alternate site
capability	Yes	Same
Hematocrit
range	20-60%	Same
Operating
condition	50°F ~ 104°F (10°C ~ 40°C),
below 85% R.H.	Same
Strip storage
condition	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 with
optional before/after meal flags	450 measurements with day
and time
Test Range	20-600 mg/dL	20-600 mg/dL
Glucose
units	mg/dL	Either mg/dL or mmol/L
Alarms	6	No
Pre-meal and
Post-meal
flags	Yes	No
B.)
Similarities
Item	Glucose Shepherd Pro Blood	Advocate Redi-Code Blood

5. Comparison to Predicate Device

A.)

3

4

Similarities
Item	Glucose Shepherd Pro Blood	Advocate Redi-Code Blood
	Glucose Monitoring System
(Proposed device)	Glucose Monitoring System
(Predicate device)
Enzyme	Glucose Oxidase	Same
Measurement
principle	Amperometric method	Same
Intended 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.

5

6

7

Dimensions	64mmx95mmx29mm	96mm(L)x20mm(W)x45mm(H)
Test time	5 seconds	7 seconds
Test volume	1.1µL	0.7µL
Memory	400 measurements with
optional before/after meal flags	450 measurements with day
and time
	Test Range	20-600 mg/dL
Glucose
units	mg/dL	Either mg/dL or mmol/L
	Alarms	6
Pre-meal and
Post-meal
flags	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.

8

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.

9

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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 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,

j

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

10

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 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.

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

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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 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.

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)

C

Division Sign-Off Office of In Vitro Diagnostic Device · Evaluation and Safety 1102316 510(k) __

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