(509 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities, image processing, or details about training/test sets which are typical indicators of AI/ML use.
No
The device is a Blood Glucose Monitoring System, intended for measuring glucose levels to aid in monitoring diabetes control. It is explicitly stated that it is "not intended for the diagnosis of or screening for diabetes mellitus," and its function is to measure, not to treat or provide therapy.
No
The intended use explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus..." This clarifies that while it measures glucose, its purpose is for monitoring effectiveness of diabetes control, not for initial diagnosis.
No
The device description explicitly states that the system consists of a meter, test strip, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use)." This phrase is repeated for all listed models (AP-2000, AP-2000multi, AP-2010, AP-2010multi, AP-2020, and AP-2020multi).
In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. Blood glucose monitoring systems fit this definition as they measure glucose levels in a blood sample outside of the body.
N/A
Intended Use / Indications for Use
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-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 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 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.
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-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.
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-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 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.
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-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.
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-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 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.
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.
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.
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.
Product codes
CGA, NBW, JJX
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-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-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for fresh capillary whole blood)
Indicated Patient Age Range
Not intended for use on neonates. No specific lower age limit for other patients is mentioned.
Intended User / Care Setting
AP-2000, AP-2010, AP-2020: at home (over the counter) [OTC] by a single patient with diabetes
AP-2000multi, AP-2010multi, AP-2020multi: multi-patient use in a professional healthcare setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 System
21 CFR Section 862.1660, Quality Control Material |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| B Classification: | Class II for 862.1345
Class I for 862.1660 |
| C. Product Code: | CGA, Glucose Oxidase, Glucose
NBW, System, Test, Blood Glucose, Over The Counter
JJX, Quality Control Material (assayed and unassayed) |
| D. Panel: | Chemistry (75) |
3. Intended Use
3.1 AP-2000 Blood Glucose Monitoring System
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-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
1
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 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-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 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-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 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-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 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-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 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.
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.
3
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
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-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-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.
5. Substantial Equivalence Information
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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,
4
- 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
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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/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
7
510(k) Number: _k103116
Device Name: __AP-2000 Blood Glucose Monitoring System
Indications for Use:
The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glocosed is c The AP-2000 Blood Glucose Montoning System is in AP-2000 Blood Glucose Monitoring Systems is intended for in Tresh capillary whole blood from the might The indicated for use at home (over the counter) [OTC] by a testing busine the booy in vitro dibgrissic coo, in aid to monitor the effectiveness of faiabetes single patient with thebetes and should not a screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole The AP-2000 Meter is thended for use in the quarterial of the AP-2000 Meter. Us indicated blood from the linger. AP-2000 blood Greesse rest and should not be shared, as an aid
for use at home (over the counter) [OTC] by a single patient with diagracia of arcerespi for use at home (over the counter) [0 re] a) a single p
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
fresh capillary whole blood from the finger. AP-2000 Blood Globacchi fresh capillary whole blood from the linge. At 2008 block even entier) [OTC] by a single patient with diabetes and Glucose weell. It is mulcated for ase at nomb (vote off diabetes control. It is not intended for the should hot be entired) a 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-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:
The AP-2000multi Blood Glucose Monitoring System is intended for use in the quantitative Systems in The Ar-2000nludi Blood Glacose Montoning Systems in AP-2000multi Blood Glucose Monitoring Systems is a intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in and Interior of testing, outside the book (in The effectiveness of diabetes control. The system is only professional nearthcare secting, as an also newsed for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000multi Meter is intended for use in the quantitative measurement of glucose in fresh capitaly the AP-200mwill The AP-2000nuti Weeks is mended for ass in the quese Test Strips must be used with the AP-2000multi White blood from the might in Esoumstil on a professional healthcare setting, as an aid to monitor the Mecel. It is nitended for multipation as only used with single-use, auto-disabling lancing devices. It is enectivelies of 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 The Ar-2000nulti Blood Glood Global Child Child Clucose Test Strips must be used the fresh capillary whole blood from the linger. The Louine and a professional healthcaresetting, as anto disabling Ar-2000matt blood clacese metel. The system is only used with single-use, auto-disabling this only instance for an are to monitor the chectivelies of 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.
Prescription Use______________________________________________________________________________________________________________________________________________________________ V 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)
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.
The AP-2010 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole The AP-2010 Meter 15 thenada for ass arose Test Strips must be used with the AP-2010 Meter. It is indicated blood nom the migen in "Euster) [OTC] by a single patient with diabetes and should not be shared, as an aid for use at home (over the counter) [0] 3] a small particles 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 me Ar-2010 Blood Glasse Tax be finger. AP-2010 Blood Glucose Test Strips must be used the AP-2010 Blood iresn capillary while blood from the angel in the counter) [OTC] by a single patient with diabetes and Oldeds welling it is morator 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-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
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)
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:
The AP-2020multi Blood Glucose Monitoring System is intended for use in the quantitative Systement of The Ar-2020nuld Blood Glacose Montering System The AP-2020multi Blood Glucose Monitoring Systems is a glucose in nest capillary whole blood from the magin use). It is intended for multi-patient use in a intended for testing, as an aid to monitor the effectiveness of diabetes control. The system is only professional nealincale setting, as an are to monter the diagnosis of or the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
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