The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or diabetes mellitus, and is not intended for use on neonates.

Device Description

The AP-3000 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 AP-3000 test strips and MAJOR control solution with the AP-3000 Blood Glucose Monitoring System.

The AP-3000multi 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 AP-3000multi test strips and MAJOR control solution with the AP-3000multi Blood Glucose Monitoring System.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for accuracy or performance metrics. Instead, it makes a general statement about meeting intended use. The table below outlines the performance characteristics mentioned, but without specific numerical targets, it's impossible to directly compare to 'acceptance criteria' in the traditional sense of a specific threshold.

Performance Characteristic	Acceptance Criteria (Implicit from "Intended Use")	Reported Device Performance
Glucose Test Range	Quantitative measurement in whole blood for diabetes monitoring	20-600 mg/dL
Temperature Range	Operable for glucose measurement	50 ~ 104°F (10 ~ 40°C)
Humidity Range	Operable for glucose measurement	< 85%
Testing Time	Timely measurement for self-testing and professional use	7 seconds
Sample Volume	Small sample volume for user convenience	0.7 μL
Sample Source	Capillary whole blood	Fingertip, palm, forearm, upper arm, calf, and thigh
Hematocrit (HCT) Range	Accurate measurement across a range of HCT levels	20-60%
Strip Open Use Time	Sufficient duration for strip use	90 days
Coding	Internal code selection for user ease	Internal Code Selection

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

The document does not explicitly state the numerical sample size used for the test set. It mentions that "The performance of AP-3000/AP-3000multi Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users."

The data provenance is not explicitly stated in terms of country of origin, but the submitter's identification is Bestgen Biotech Corporation in Taipei, Taiwan. The studies were conducted in "clinical settings by healthcare professionals and lay users," suggesting prospective data collection.

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

This information is not provided in the given text. For glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus in the way it might be for image analysis.

4. Adjudication Method (for the test set)

This information is not provided in the given text.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a blood glucose monitoring system, and the evaluation focuses on its accuracy against a reference method, not on human interpretation of images or other data with and without AI assistance.

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

The performance study described is inherently a "standalone" evaluation of the device itself (meter and strips) as it measures glucose levels, rather than an AI algorithm integrated with human interpretation. The study "demonstrated that the performance of this system meets its intended use," implying evaluation of the device's accuracy without human intervention influencing the reading of glucose levels.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated as "expert consensus," "pathology," or "outcomes data." However, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI analyzer), to which the device's readings are compared for accuracy. The text states "The performance... was studied in the laboratory," which supports this inference.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Blood glucose monitoring systems like the AP-3000/AP-3000multi traditionally rely on electrochemical biosensor technology and are not typically "trained" in the machine learning sense with a data set. Their performance is validated through rigorous testing against reference methods.

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

This information is not applicable as there is no "training set" in the context of a machine learning algorithm for this type of device.

Summary

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510(k) Summary

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

The Assigned 510(k) number is K103230

1. Submitter's Identification

Bestgen Biotech Corporation 7F., No.186, Jian-Yi Rd., 235, Jung-He City, Taipei, Taiwan

Correspondence: Steven Shen Q.A./ Regulatory Manager Tel: +886-2-8227-2188 Ext 211 Fax: +886-2-8227-2178 E-mail: stevenshen@mail.bestgen.com.tw

2. Device Name

Proprietary name: AP-3000 and AP-3000multi Blood Glucose Monitoring System

Regulatory information:

A. Regulation section:	21 CFR Section 862.1345 Glucose Test System21 CFR Section 862.1660, Quality Control Material
B Classification:	Class II for 862.1345Class I for 862.1660
C. Product Code:	CGA, Glucose Oxidase, GlucoseNBW, System, Test, Blood Glucose, Over The CounterJJX, Quality Control Material (assayed and unassayed)
D. Panel:	Chemistry (75)

3. Intended Use

3.1 AP-3000 Blood Glucose Monitoring System

The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and 1 thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used with the AP-3000 Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to

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be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000 Blood Glucose Test Strips are in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used the AP-3000 Blood Glucose Meter. The AP-3000 Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

MAJOR Level I/Level II Control Solution is for use with AP-3000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.2 AP-3000multi Blood Glucose Monitoring System

The AP-3000multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-3000multi Meter. AP-3000multi Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000multi Blood Glucose Test Strips are in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-300multi Meter. AP-3000multi Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

MAIOR Level I/Level II Control Solution is for use with AP-3000multi meter and AP-3000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

4. Device Description

5. Substantial Equivalence Information

A. Predicate device name:

AP-1000 Blood Glucose Monitoring System

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B. Predicate K number: K090389

C. Comparison with predicate:

The new device of AP-3000/AP-3000multi Blood Glucose Monitoring System has the following similarities to the predicate device:

Similarities
Item	Device(AP-3000/AP-3000multi BGMS)	Predicate(AP-1000 BGMS, K090389)
Detection Method	Amperometry	Amperometry
Enzyme	Glucose Oxidase(Aspergillus niger)	Glucose Oxidase(Aspergillus niger)
Test Range	20-600 mg/dL	20-600 mg/dL
Temperature Range	50 ~ 104°F (10 ~ 40°C)	50 ~ 104°F (10 ~ 40°C)
Open Use Time (Strip)	90 days	90 days
Coding	Internal Code Selection	Internal Code Selection

Differences
	r Device(AP-3000/AP-3000multi BGMS)	Predicate(AP-1000 BGMS, K090389).
Meter Size	55mm x 88mm x26mm	54mm x 93mm x 16 mm
Meter Weight	65 g (with battery)	53 g (with battery)
Strip Ejection	Yes	No
LCD with Backlight	Yes	No
Memory Capability	488 measurements	960 measurements
Power	Two AAA batteries	One CR2032 3V lithium battery
Humidity Range	< 85%	20~80%
Testing Time	7 seconds	6 seconds
Sample Volume	0.7 pl	0.6 pl
Sample Source	The glucose concentration ismeasured with quantitativecapillary whole blood from thefingertip, palm, forearm, upperarm, calf, and thigh.	The glucose concentration ismeasured with quantitativecapillary whole blood from thefingertip.
HCT Range	20-60%	30-55%

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6. Test Principle

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

7. Performance Characteristics

The performance of AP-3000/AP-3000multi 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.

8. Conclusion

Based on the information provided in this submission, the AP-3000multi Glucose Monitoring System is substantially equivalent to the predicate AP-1000 Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a serif font. The logo is black and white.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bestgen Biotech Corporation c/o Mr. Steven Shen Ouality Assurance Manager 7F., No. 186, Jian-Yi Road, Jung-He City Taipei, Taiwan, 235, ROC

K103230 Re:

Trade Name: AP-3000 Blood Glucose Monitoring System AP-3000multi Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: April 19, 2012 Received: April 23, 2012

Dear Mr. Shen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and minted to rollerice reporting (reporting of medical device-related adverse events) (21 007); medical Leoney reanufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

APR 2 4 2012

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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/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

Countney 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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Indications for Use

510/k) Number: K103230

Device Name: AP-3000 Blood Glucose Monitoring System

Indications for Use:

The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used with the AP-3000 Meter. The AP-3000 Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used the AP-3000 Blood Glucose Meter. The AP-3000 Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

MAJOR Level I/Level II Control Solution is for use with AP-3000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(21 CFR Part 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Q ch

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

510(k) K103230

Page 1 of 2

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Indications for Use

510(k) Number: K103230

Device Name: AP-3000mutli Blood Glucose Monitoring System

Indications for Use:

The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-300multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-3000multi Meter. AP-3000multi Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting; as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-3000multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-3000multi Meter. AP-3000multi Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

MAJOR Level I/Level II Control Solution is for use with AP-3000multi meter and AP-3000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use V (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use_ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

B. Cline

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

K103230 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.