ADVOCATE® Redi-Code* BMB-EA001S 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 ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, 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 of diabetes, or for the testing of neonates.

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A 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 meter also included speaking functions but has not been validated for use by the visually impaired.

The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists of the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement "Same accuracy for both systems" and the reference to "Attachment 13.1 System Accuracy Study," which is stated to prove the system meets the performance requirements. While the specific numerical acceptance criteria (e.g., ISO standards for blood glucose meters) are not explicitly detailed in the provided text, the comparison to the predicate device K102316 suggests that the performance requirements are aligned with previously cleared devices.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy	Equivalent to the predicate device (K102316)	"Same accuracy for both systems. Please refer to Attachment 13.1 System Accuracy Study"
Precision	Equivalent to the predicate device (K102316)	"Same precision for both systems. Please refer to Attachment 12.1 Precision Study"
Linearity	Equivalent to the predicate device (K102316)	"Same linearity for both systems. Please refer to Attachment 12.2 Linearity Study"
Lay User Evaluation	Users meet "no problem when reading the material" (speaking function)	"Attachment 13.3 Customer and Alternate Site Testing Performance Evaluation. Speaking Function Evaluation Report, indicating the speaking function really increase the users' convenience, is also attached."
Interfering Substances	Same as the predicate device (K102316)	Listed effects of various substances (Acetaminophen, Ascorbic acid, Dopamine, L-dopa, Tolbutamide, Uric acid, Gentisic acid, Tolazamide, Mannose, Ibuprofen)
Disinfectant Protocol	Same as the predicate device (K102316)	"Same disinfectant protocol has been verified to work for both systems"
Altitude	Same as the predicate device (K102316)	"Same altitude, up to 10745 feet."
EMC Testing	Adherence to IEC 61326-1:2005, EN 61326-1:2006, IEC 61326-2-6:2005, EN 61325-2-6:2006	Device meets these standards (TUV Rheinland, Registration No.: AK 50221354 0001)
Glucose Meter Software	Blood glucose detection and data analysis algorithm is identical to predicate	"Blood glucose detection and data analysis algorithm is identical. (See 'Attachment 13.2 Method Comparison Report')"
Control Solutions	Same control solution levels used for both systems	"Same control solution level 1/2/3"

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

The provided text does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the accuracy, precision, and linearity studies. It only mentions that these studies were conducted and their results are comparable to the predicate device. For the "Lay user evaluation," it mentions an "evaluation report from Arkansas," implying some data was collected within the USA. However, specific numbers for participants or the nature of the data (retrospective/prospective) are not given.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for any of the studies. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory method.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. For blood glucose measurements, ground truth is usually determined by a highly accurate laboratory method, removing the need for expert adjudication in comparing device readings to the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable to this device. This type of study is relevant for imaging devices or diagnostics where human interpretation is involved. The ADVOCATE® Redi-Code+ BMB-EA001S is a blood glucose monitoring system that provides a quantitative measurement, not requiring human interpretation of results in the way an MRMC study would assess. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

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

Yes, the primary performance studies (Accuracy, Precision, Linearity, Interference, Altitude, EMC testing) are inherently standalone studies. The device itself performs the measurement and provides a quantitative result. The "Lay user evaluation" focuses on usability and understanding of the speaking function, but the core accuracy is assessed in a standalone manner by comparing device output to reference measurements. The "Blood glucose detection and data analysis algorithm is identical" to the predicate, implying standalone performance.

7. The Type of Ground Truth Used

The ground truth used for performance validation (accuracy, precision, linearity) for blood glucose meters is typically established by laboratory reference methods/instruments. The text refers to "System Accuracy Study" and "Method Comparison Report," which strongly indicates that the device's readings were compared against a gold standard laboratory method for glucose measurement. The nature of the device (quantitative blood glucose meter) makes expert consensus or pathology less relevant for "ground truth" of the measurement itself, though clinical outcomes are relevant for the overall impact of monitoring.

8. The Sample Size for the Training Set

The document does not provide any explicit information about the sample size of a training set. As this device is based on an amperometric method and uses a glucose oxidase enzyme, the "algorithm" for blood glucose concentration calculation, noted as being "Same" as the predicate, is likely a well-established scientific principle rather than a machine learning model requiring a distinct training set in the modern sense. If any form of "training" or calibration data was used for the algorithm, it is not separately detailed.

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

Since an explicit "training set" and its ground truth establishment are not discussed (as per point 8), this information is not provided in the document. The system relies on a physical-chemical principle and an established algorithm, not a machine learning model that learns from a distinct training dataset with its own ground truth.

Summary

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K12018 3

MAY 1 1 2012

510(k) Summary (Per 21 CFR 807.92)

l. Submitter Information Company Name Address

Contact Person
Phone
Fax
Email

Date Prepared

1. Device Name Proprietary Name
  Common Name Classification Number

Classification Panel Product Code Regulation Number

1. Predicate Device Proprietary Name
  Common Name Manufacturer 510(k) Number

BroadMaster Biotech Corporation 7F, NO. 168-2 , Liancheng Rd , Zhonghe Dist , New Taipei City 235 , Taiwan ( R.O.C ) Roger Lai/Blanc Lin 886-987-111105/886-2-66375859 886-2-22428332 roger@broadmaster-biotech.com blanc@broadmaster-biotech.com 2012/1/20

ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System Blood Glucose Test System System, Test, Blood Glucose, Over the Counter 75, Clinical Chemistry NBW, CGA 21 CFR 862.1345 Glucose Test System

Glucose Shepherd Blood Glucose Monitoring System Blood Glucose Test System BroadMaster Biotech Corporation K102316

4. Device Description

The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists f the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, 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

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presented in the sample, providing a quantitative measure of glucose level in whole blood.

Intended Use

The ADVOCATE® Redi-Code BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code+ BMB-EA001S meter are used only with ADVOCATE® Redi-Code BMB-BA006A 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 ADVOCATE® Redi-Code * BMB-EA001S Blood Glucose Meter also includes speaking functions but has not been validated for use by the visually impaired.

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5. Comparison to Predicate Device
Item	Candidate device	Predicate device
	ADVOCATE® Redi-Code+BMB-EA001S Blood GlucoseMonitoring System	K102316
Similarities and Differences
Appearance	Image: ADVOCATE Redi-Code	Image: Bread Master
Similarities
Intended use	Same for both systems.
Enzyme	Glucose Oxidase, same formula and strip design for both systems
Test strips	Same, BMB-BA006A test strips are for the use with both systems
Test sample (finger,arm...)	Same for both systems, fresh capillary whole blood(finger ,palm, forearm, upper arm, calf and thigh)
Measuring range	Same for both systems, 20-600 mg/dL
Hematocrit	Same for both systems, 20-60%
Required sample volume	Same for both systems, 1.1μL
Reaction time	Same for both systems, 5 seconds
Coding function	Same for both systems, no coding
Operation condition	50°F~104°FBelow 85% R.H.
MCU	TI MSP430
Algorithm (Bloodglucose concentrationcalculation)	Same
The core circuit for the	Same
measurement
Power source	Two 1.5V AAA alkaline batteries
Weight (withoutbatteries)	53g
Memory	400 measurements
Dimension(mm)	649529
LCD display	Image: LCD display
General/ Pre-meal/Post-meal selection	Same for both systems
Precision	Same precision for both systems. Please refer toAttachment 12.1 Precision Study
Linearity	Same linearity for both systems. Please refer toAttachment 12.2 Linearity Study
Accuracy	Same accuracy for both systems. Please refer toAttachment 13.1 System Accuracy Study
Lay user evaluation	Attachment 13.3 Customer andAlternate Site TestingPerformance Evaluation.Speaking Function EvaluationReport, indicating the speakingfunction really increase the users'convenience, is also attached.	Easy to be used.
Interference	Same interference as the table listed in K102316. When testedfollowing NCCLS guidelines, bilirubin, creatinine, methyldopa,galactose, maltoase, xylose, salicylate, cholesterol,hemoglobinandtriglycerides at therapeutic concentrations do not significantly affectglucose results. However, these levels of the following interferencesin blood may cause inaccurate test results:Acetaminophen $\geq$ 12.5 mg/dL (Therapeutic level is 1.2-3.6 mg/dL)Ascorbic acid $\geq$ 7.5 mg/dL(Therapeutic level is 0.4-2.1 mg/dL)Dopamine $\geq$ 3 mg/dL (Therapeutic level is 0.04 mg/dL)L-dopa $\geq$ 4 mg/dL (Therapeutic level is 0.02-0.3 mg/dL)
Tolbutamide≥ 150 mg/dL (Therapeutic level is 3.6-7.2 mg/dL)
Uric acid ≥20 mg/dL (Normal level is 2.6-7.2 mg/dL)
Gentisic acid ≥ 25 mg/dL (Therapeutic level is 0.2-0.6 mg/dL)
Tolazamide ≥ 15 mg/dL (Therapeutic level is 2.0-2.5 mg/dL)
Mannose≥250 mg/dL(Therapeutic level is 1.15 mg/dL)
Ibuprofen≥ 50 mg/dL(Therapeutic level is 1.0-7.0 mg/dL)
Disinfectant Protocol	Same disinfectant protocol has been verified to work for bothsystems
Altitude	Same altitude, up to 10745 feet.
EMC testing	IEC 61326-1:2005	IEC 61326-1:2005
	EN 61326-1:2006	EN 61326-1:2006
	IEC 61326-2-6:2005	IEC 61326-2-6:2005
	EN 61325-2-6:2006	EN 61325-2-6:2006
	(TUV Rheinland ,RegistrationNo.: AK 50221354 0001)	(TUV Rheinland ,RegistrationNo.: AK 50186220 0001)
	Glucose meter software	Blood glucose detection and data analysis algorithm is identical.(See “Attachment 13.2 Method Comparison Report”)
Control solutions clearedin 510(k) #	Same control solution level 1/2/3
	Difference
User manual (markdifferences in red whencompared with thepredicate)	Please refer to the section marked in red in the user manual
Readability assessmentfor labeling material(User manual; test stripinsert, control solutionsinsert)	The only difference of the labeling material is the section regardingthe meter speaking function in the user manual. Per the evaluationreport from Arkansas it shows users have met no problem whenreading the material.
Color and Material forthe housing and button	Red ABS	Blue ABS
Additional function--English/SpanishSpeaking Instruction	Yes	No
Battery Life	Over 500 times	Over 1000 times

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રાદ

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6. Performance Studies

The performance of the ADVOCATE® Redi-Code* BMB-EA001S 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

The laboratory testing results, clinical testing results and labeling of ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System match the Indications for Use and support the claim of substantial equivalence to the predicate.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human figure or a caduceus, a symbol often associated with medicine and healthcare.

10903 New Hampshire Avenue Silver Spring, MD 20993

Broadmaster Biotech Corperation c/o Roger Lai 7F, No. 168-2, Liancheng Rd Zhonghe Dist. New Taipei City 23553 Taiwan (R.O.C) China

MAY 1 1 2012

K120183 Re:

K120183
Trade Name: Advocate® Redi-Code+ BMB-EA001S Blood Glucose Monitoring

System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: April 10, 2012 Received: April 11, 2012

Dear Mr. Lai:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> referenced above and have detemmed the benefits substance of cadicate devices marketed in
indications for use stated in the enclosure) to legally marketed in
the enclosed in indications for use stated in the enclosure) to tegally manaded portuges of the Medical Device
interstate commerce prior to May 28, 1976, the enactment of the provisio interstate commerce prior to May 23, 1976, the eniace with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions of Amendments, or to devices that have been fectassined in actrequire approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug, and Cosmetic Act (Act (Act ) the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gen approval application (PMA). controls provisions of the Act. Ine general controls provisems of the entrols practice,
requirements for annual registration, listing of devices, good manufacturing practic requirements for annual registration, nomig and adulteration.
labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
n affective and control and colditional controls. Existing major regulations af If your device is classified (see above) into eline) in (opermajor regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations (CF (PMA), it may be subject to such additional Colliols: Existing mayor roger roger of S00 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Part your device can be found in Title 21, Code of Federal Regulation (400),
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 Please be advised that FDA's issuance of a substantial equirements
mean that FDA has made a determination that your device with other requirements. mean that FDA has made a determination intributions administered by other Federal agencies.
of the Act or any Federal stations and regulations and not limited to: registratio of the Act or any Federal stantify and regulations administered of on the Act of registration
You must comply with all the Act's requirements, including, but not limited to: You must comply with all the Act S requirements, including of the more of the senses of the senses
and listing (21 CFR Part 807); Incience related adverse exemps) (21 CFR 803 and listing (21 CFR Part 807); labeling (21 CFR Pars overs) (21 CFR 803); and good
reporting (reporting of medical devices ast fark in the quality systems (QS) regulation reporting (reporting of medical device-related adverse evenis) (21 UN 000), in any former
manufacturing practice requirements as set forth in the quality systems (OS) regulat CFR Part 820).

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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/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

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

Enclosure

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510(k) Number K120183

Device Name:

ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System

Indications For Use:

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

(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)

Quto. Clule-

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 1220183

Page 1 of 1

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.