The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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-2000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000multi 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. The 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-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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-2010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010multi 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. The 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-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) (OTC) by a single patient with diabetes and should not be shared, as an 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-2020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020multi 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. The 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.

Device Description

The AP-2000 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-2000 test strips and MAJOR control solution with the AP-2000 Blood Glucose Monitoring System.

The AP-2010multi 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-2010multi test strips and MAJOR control solution with the AP-2010multi Blood Glucose Monitoring System.

The AP-2010 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-2010 test strips and MAJOR control solution with the AP-2010 Blood Glucose Monitoring System.

The AP-2020 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-2020 test strips and MAJOR control solution with the AP-2020 Blood Glucose Monitoring System.

The AP-2020multi 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-2020multi test strips and MAJOR control solution with the AP-2020multi Blood Glucose Monitoring System.

AI/ML Overview

This 510(k) summary does not contain sufficient information to directly answer all components of your request, specifically regarding detailed acceptance criteria, the study design, and sample sizes for training and testing as typically found in comprehensive clinical/performance studies.

The document is a 510(k) summary for new glucose monitoring systems (AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi), stating their substantial equivalence to a predicate device (AP-1000 Blood Glucose Monitoring System, K090389). It emphasizes that the new devices have the "same performance characteristics as the predicate device" and that "A comparison of system accuracy performance demonstrated that... [new devices]... are substantially equivalent." This implies that the acceptance criteria and performance data for the new devices are considered to be met by virtue of their equivalence to the predicate device, for which performance data presumably exists elsewhere.

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

1. A table of acceptance criteria and the reported device performance:

The document states that the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." It also states, "A comparison of system accuracy performance demonstrated that... [the new devices]... are substantially equivalent."
Since no explicit acceptance criteria or detailed performance results are provided in this 510(k) summary for the new devices beyond this statement of equivalence, we must infer that the acceptance criteria and reported performance would be those met by the predicate device (AP-1000). Without the predicate's performance data, specific numbers are unavailable from this document.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance (Inferred as equivalent to Predicate)
(Not explicitly stated in this document; assumed to be equivalent to the predicate AP-1000's criteria, likely following ISO 15197 or similar standards for glucose meters)	"Same performance characteristics as the predicate device" (AP-1000). "System accuracy performance demonstrated... [new devices]... are substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified in this document. The submission relies on demonstrating "substantial equivalence" to a predicate device rather than presenting new detailed performance study data for the new devices themselves.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the device is a Blood Glucose Monitoring System, which measures a quantitative biochemical marker. The "ground truth" for glucose measurements would typically be established by a laboratory reference method (e.g., hexokinase method) rather than expert human consensus on image or clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for a quantitative blood glucose measurement device. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads) that require consensus among experts.

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:

This is not applicable. An MRMC study is relevant for imaging or diagnostic interpretation tasks involving human readers, typically in conjunction with AI assistance. This device is a standalone in-vitro diagnostic device for quantitative glucose measurement.

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

The performance characteristics mentioned are for the "AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System," which is an integrated system (meter, test strips, control solutions). The "system accuracy performance" mentioned implies a standalone performance evaluation of the device itself. No human-in-the-loop interaction for interpretation (like with AI tools) is suggested, as it provides a direct quantitative reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

While not explicitly stated in this document, for blood glucose monitoring systems, the "ground truth" would almost certainly be established by a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods using a central lab analyzer), not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Sample Size for Training Set: Not specified. This submission focuses on "substantial equivalence" to a predicate, not on a de novo device with an explicit training dataset. The device is a hardware/software system, and "training set" would typically refer to data used to develop or calibrate the algorithm, which is not detailed here.

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

This information is not specified in the provided document. If a training set was used for algorithmic development, the ground truth would similarly be established by a laboratory reference method, as mentioned in point 7.

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 K103116

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-2000, AP-2000multi, AP-2010multi, AP-2020, and AP-2020multi 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-2000 Blood Glucose Monitoring System

The AP-2000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000 Blood Glucose Test Strips must be used with the AP-2000 Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for

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diabetes mellitus, and is not intended for use on neonates.

The AP-2000 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000 Blood Glucose Test Strips must be used the AP-2000 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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.

MAJOR Level I/Level II Control Solution are for use with AP-2000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.2 AP-2000multi Blood Glucose Monitoring System

The AP-2000multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000multi Blood Glucose Test Strips must be used with the AP-2000multi Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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-2000multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000multi Blood Glucose Test Strips must be used the AP-2000multi Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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-2000multi meter and AP-2000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.3 AP-2010 Blood Glucose Monitoring System

The AP-2010 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010 Blood Glucose Test Strips must be used with the AP-2010 Meter. It is indicated for use at home {over the counter} [OTC] by a single patient with diabetes and should not be shared, as an 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-2010 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010 Blood Glucose Test Strips must be used the AP-2010 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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.

MAJOR Level I/Level II Control Solution are for use with AP-2010 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.4 AP-2010multi Blood Glucose Monitoring System

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The AP-2010multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010multi Blood Glucose Test Strips must be used with the AP-2010multi Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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-2010multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010multi Blood Glucose Test Strips must be used the AP-2010multi Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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-2010multi meter and AP-2010multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.5 AP-2020 Blood Glucose Monitoring System

The AP-2020 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020 Blood Glucose Test Strips must be used with the AP-2020 Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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-2020 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020 Blood Glucose Test Strips must be used the AP-2020 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an 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.

MAJOR Level I/Level II Control Solution are for use with AP-2020 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

3.6 AP-2020multi Blood Glucose Monitoring System

The AP-2020multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020multi Blood Glucose Test Strips must be used with the AP-2020multi Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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.

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The AP-2020multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020multi Blood Glucose Test Strips must be used the AP-2020multi Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The 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-2020multi meter and AP-2020multi 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
B. Predicate K number: K090389
C. Comparison with predicate:

The modified AP-2000, AP-2000multi, AP-2010multi, AP-2020, and AP-2020multi 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,

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same shelf life
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
different power source-batteries and software change
the printed circuit board (PCB) was changed
the software was modified
the addition of a speaking function

6. Test Principle

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

7. Performance Characteristics

AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System and the currently marketed AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020multi Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi Blood Glucose Monitoring System are equivalent to the predicate device.

8. Conclusion

Based on the information provided in this submission, the AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi 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

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

MAR 1 3 2012

Re: K103116

Trade Name: AP-2000/AP-2000multi, AP-2010/AP-2010multi, and AP-2020/AP-2020multi Blood Glucose Monitoring Systems Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, CGA, JJX Dated: February 23, 2012 Received: March 2, 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 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good

{6}------------------------------------------------

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/Resourcesfor You/Industry/default.htm

Sincerely yours.

Courtney 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: _k103116

Device Name: __AP-2000 Blood Glucose Monitoring System

Indications for Use:

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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-2000 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in The AP-2000 Blood Glucose Test Strips are Thenable Ter Colorse Test Strips must be used the AP-2000 Blood
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MAJOR Level I/Level I/Level II Control Solution are for use with AP-2000 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)

Qutle Chealer

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

510(k) K103116

Page 1 of b

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

510(k) Number: k103116

Device Name: _ AP-2000multi Blood Glucose Monitoring System

Indications for Use:

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MAJOR Level I/Level II Control Solution is for use with AP-2000multi meter and AP-2000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use______________________________________________________________________________________________________________________________________________________________ V And/Or

(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)

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

K103116 510(k)

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

510(k) Number: K103116

Device Name: AP-2010 Blood Glucose Monitoring System

Indications for Use:

The AP-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose f firesh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for in hesn capilary whole blood from the might ell be indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes Shifele patient with thoughts of or sharts not of the engine for diabetes mellitus, and is not intended for use on neonates.

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MAJOR Level I/Level I/Level II Control Solution are for use with AP-2010 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_ V (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)

Ruth Cireler

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

K103116 510(k)

Page 3 of 6

{10}------------------------------------------------

510(k) Number: K103116

Device Name: __AP-2010multi Blood Glucose Monitoring System

Indications for Use:

The AP-2010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of The AP-2010marti Blood Glood from the finger. The AP-2010multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a meended for testing outside the boain to monitor the effectiveness of diabetes control. The system is only prolessional neathedre secting as an all to not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-2010multi Meter is intended for use in the quantitative measurement of glucose in fresh apillary rrie Al-2010multi Meter 15 meenage 16 Blood Glucose Test Strips must be used with the AP-2010multi whole blood from the might in a professional healthcare setting, as an aid to monitor the wices. It is "intended" for the mail. The system is only used with single-use, auto-disabling lancing devices. It is encerest of the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-2010multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in The Ar-2010mant Diood Clause less of Apart AP-2010multi Blood Glucose Test Strips must be used the fresh 'oppliary where theou for multi-patient use in a professional healthcare setting, as At 2020multi Blood Glacose Mister is is a beter is only used with single-use, auto-disabling an and to monton the Chectressor 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-2010multi meter and AP-2010multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use_ V And/Or

Over the Counter Use_ V (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)

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

K103116 510(k)

Page 4 of 6

{11}------------------------------------------------

510(k) Number: K103116

Device Name: _ AP-2020 Blood Glucose Monitoring System

Indications for Use:

The AP-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose rne Al-2020 Blood Glucose Montoning System The AP-2020 Blood Glucose Monitoring Systems is intended for in fresh capillary while blog wont are to the indicated for use at home (over the counter) [OTC] by a testing outline with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes single patient with thinks and and one of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-2020 Meter is intended for use in the quantitative measurement of glucose in freeh capillary whole The AP-2020 Meter is Thenada Glucose Test Strips must be used with the AP-2020 Meter. It is indicated blood from the miger. Ar 2020 the counter) [OTC] by a single patient with diabetes and should not be shared, as and for use at none (over the counter) [075] 3] a crogic in the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-2020 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucos in The AP-2020 Blood Glacose Test Strips are interesal to Glucose Test Strips must be used the AP-2020 Blood
fresh capillary whole blood from the finger. AP-2020 Blood Glucose a n en capillary while brood new at home (over the counter) [OTC] by a single patient with diabetes and Ghouse week. It is marated for as onitor 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.

MAJOR Level I/Level I/Level II Control Solution are for use with AP-2020 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use_

And/Or

(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)

Rute C. Chealen

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

K103116 510(K)

Page 5 of 6

{12}------------------------------------------------

510(k) Number: K103116

Device Name: __AP-2020multi Blood Glucose Monitoring System

Indications for Use:

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The AP-2020multi Meter is intended for use in the quantitative measurement of glucose in fresh apillary The AP-2020riulti Meer is Intended for ass in the quality.
whole blood from the finger. AP-2020multi Blood Glucose Test Strips must be used to moster the whole blood from the mige. An a professional healthcare setting, as an aid to monitor the Meter. It is Intended for multi-patent use in a professional nisely and other lancing devices. It is
effectiveness of diabetes control. The system is only used with single of effectivelies of ulabetes control. The System's Grilly association of thended for use on neonates.
not intended for the diagnosis of or screening for diabetes mellitus, and i

The AP-2020multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in The AP-2020multi Blood Glocose lest Schps are incentual is Blood Glucose Text Strips must be used the rresh Capillary whole blood from the linger in a professional healthcarse setting, as and disabling AP-2020multi Blood Glucose Meter. It is thenoca for make psee with single-use, auto-disabling
an aid to monitor the effectiveness of diabetes control. The system is not in no an alo to monitor the enectiveness of albectes control 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-2020multi meter and AP-2020multi Blood Glucose MASON Lever If Ecver if Control Celeck to verify the accuracy of blood glucose test results.

Prescription Use_ V And/Or

Over the Counter Use_ V (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)

Rute Chosler

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

510(k) K103116

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.