The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1010multi Blood Glucose Monitoring System

The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use 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-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1020 Blood Glucose Monitoring System

The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1020multi Blood Glucose Monitoring System

The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use 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-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Description

The AP-1010 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-1010 test strips and MAJOR control solution with the AP-1010 Blood Glucose Monitoring System.

The AP-1010multi 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-1010multi test strips and MAJOR control solution with the AP-1010multi Blood Glucose Monitoring System.

The AP-1020 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-1020 test strips and MAJOR control solution with the AP-1020 Blood Glucose Monitoring System.

The AP-1020multi 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-1020multi test strips and MAJOR control solution with the AP-1020multi Blood Glucose Monitoring System.

AI/ML Overview

The provided text is a 510(k) summary for the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring Systems. This document focuses on demonstrating substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389), rather than presenting a detailed de novo study with specific acceptance criteria and performance data for the current device.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this specific 510(k) summary because the submission relies on the established performance of the predicate device.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated for this device in the provided document. The submission hinges on "substantial equivalence" to the predicate device.	The document states: "AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
Performance of the predicate device (AP-1000) would contain the relevant acceptance criteria and performance data.	Software verification and validation testing confirmed that the performance, safety and effectiveness of the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System are equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in this 510(k) summary. The submission asserts equivalence to a predicate device, implying that the performance data for the predicate device forms the basis of performance.
Data Provenance: Not specified for any new testing for these specific devices. The previous 510(k) for the AP-1000 (K090389) would contain this information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. Blood glucose monitoring systems typically use a laboratory reference method (e.g., YSI analyzer) as the ground truth, not expert consensus/adjudication.

4. Adjudication method for the test set

Not applicable and not provided. Blood glucose measurements are quantitative and compared directly to a reference method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting results.

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

The device is a standalone blood glucose monitoring system. Its performance is evaluated based on the accuracy of its glucose measurements compared to a laboratory reference. The submission explicitly states "Software verification and validation testing confirmed that the performance, safety and effectiveness... are equivalent to the predicate device." This implicitly refers to standalone performance.

7. The type of ground truth used

While not explicitly stated for these specific modified devices in this document, for blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which is highly accurate and traceable to certified standards.

8. The sample size for the training set

Not applicable and not provided. This is a medical device based on electrochemical biosensor technology, not an AI/ML model that requires a "training set" in the conventional sense. Software validation is mentioned, but not "training set."

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

Not applicable (see point 8).

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves the device meets acceptance criteria" is implicitly the original 510(k) submission for the predicate device, AP-1000 Blood Glucose Monitoring System (K090389).

For the current submission (K103044), Bestgen Biotech Corporation performed testing (including "Software verification and validation testing") to demonstrate that the modifications to the AP-1010, AP-1010multi, AP-1020, and AP-1020multi systems did not change the "performance characteristics" of the device from its predicate. The modifications primarily involved "engineering change in the mechanical appearance of the device and name change."

The conclusion of this 510(k) states: "Based on the information provided in this submission, the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System is substantially equivalent to the predicate AP-1000 Blood Glucose Monitoring System." This means that the original performance data and acceptance criteria established for the AP-1000 are deemed sufficient to cover these modified devices due to their substantial equivalence. The document does not elaborate on new performance studies for these specific models.

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 K103044

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-1010, AP-1010multi, AP-1020, and AP-1020multi 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 Counter
D. Panel:	Chemistry (75)

3. Intended Use

AP-1010 Blood Glucose Monitoring System

The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh

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capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

AP-1010multi Blood Glucose Monitoring System

AP-1020 Blood Glucose Monitoring System

AP-1020multi Blood Glucose Monitoring System

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4. Device Description

5. Substantial Equivalence Information

A. Predicate device name: AP-1000 Blood Glucose Monitoring System

B. Predicate K number: K090389
C. Comparison with predicate:

The modified AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System have the following similarities to the predicate device:

same operating principle,
- same fundamental scientific technology, .
- incorporate the same basic circuit design,
- incorporate the same materials,
- same shelf life 프
- same software validation
- packaged using the same materials, and
- manufactured by same process

The modifications encompass:

engineering change in the mechanical appearance of the device and name change

6. Test Principle

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

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using glucose oxidase.

7. Performance Characteristics

AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System are equivalent to the predicate device.

8. Conclusion

Based on the information provided in this submission, the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood 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 consists of two main elements: a circular seal containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" and a stylized symbol resembling an abstract caduceus or a bird-like figure. The seal surrounds the symbol, creating a unified emblem representing the department.

Public Health Service

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

Bestgen Biotech Corp. c/o Steven Shen Q.A./Regulatory Affairs Manager 7f, No 186, Jian-Yi Road, Jung-He, Taipei County China (TAIWAN) 235

FEB 1 0 2012

Re: K103044

Re: K103044
Trade/Device Name: AP-1010/AP-1010multi and AP-1020/AP-1020multi Blood Glucose Monitoring Systems

Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, CGA Dated: December 16, 2011 Received: December 16, 2011

Dear Mr. Shen:

We have reviewed your Section 510(k) premarket notification of intent to market the We have leviewed your Section 310(t) projection is substantially equivalent (for device felefenced above and have development to legally marketed predicate devices.
the indications for use stated in the enclosure) to legally marketed predicate of the the indications for use stated in the encreases, 1976, the enactment date of the marketed in mersiale commerce prior to they == that have been reclassified in accordance Medical Device Amendments, of to Gevece Inc. Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require with the provisions of the Federal Pood, Drag, MA). You may, therefore, market the approval of a premarker approval upproval upprovisions of the Act. The general controls device, subject to the general controls provisions dal registration, listing of devices, good provisions of the Act mender requirements for unitial organding 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 (CEF (PMA), it may be subject to such adultional connects and regulations (CFR), Parts affecting your device can be found in This 21, Geas of Courter. in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised fill PDA s Issualled of a success of a success or more and not mean that FDA has made a determinations and regulations administered by other requirements of the Act of any recent stately with all the Act's requirements, including, but not
Federal agencies. You must connect of a compare of CER Parts 801 and Federal agencies. You must compry with and 007); labeling (21 CFR Parts 801 and limited to: registration and listing (21 Cr (1 (1 ) (1 ) (1 c = elated adverse events) (21 809); medical device reporting treporting tractice requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 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,

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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Indication for Use

510(k) Number (if known): K103044

Device Name: AP - 1010 Blood Glucose Monitoring System

Indication For Use:

The AP - 1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010 Blood Glucose Test Strips must be used with the AP - 1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

Over the Counter Use X (21 CFR Part 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)

1 A

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

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510(k) Number (if known): K103044

Device Name: AP-1010multi Blood Glucose Monitoring System

Indication For Use:

The AP - 1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use 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 - 1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010multi Blood Glucose Test Strips must be used with the AP - 1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

Over the Counter Use X (21 CFR Part 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)

Signature

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

{8}------------------------------------------------

510(k) Number (if known): K103044

Device Name: AP-1020 Blood Glucose Monitoring System

The AP - 1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020 Blood Glucose Test Strips must be used with the AP - 1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

Over the Counter Use X (21 CFR Part 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 (OVD)

Signature

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

{9}------------------------------------------------

510(k) Number (if known): K103044

Device Name: AP-1020multi Blood Glucose Monitoring System

The AP - 1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use 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 - 1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020multi Blood Glucose Test Strips must be used with the AP - 1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

Over the Counter Use X (21 CFR Part 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 (OVD)

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

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.