# K103116: AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Bestgen Biotech Corp.
- Decided: Mar 13, 2012 after 509 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964630 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090389: AP-1000 Blood Glucose Monitoring System, Bestgen Biotech Corp. (2009) Summary page 4.

## 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 11Control Solution are for use with AP-2000 meter and 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 11Control Solution is for use with AP-2000mullti meter and AP-2000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. The A17-2010 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 11Control Solution are for use with AP-2010 meter and AP-2010 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. The AP-2Ol0multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2Ol0multi 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-2Ol0multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2Ol0multi Blood Glucose Test Strips must be used with the AP-2Ol0multi 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-2Ol0multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2Ol0multi Blood Glucose Test Strips must be used the AP-2Ol0multi 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 11Control Solution is for use with AP-2Ol0multi meter and AP-2Ol0multi 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 iiitended 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 11Control Solution are for use with AP-2020 meter and.AP-2020 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. The AP-2OZ0multi Blood Glucose monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2O2Omulti 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-2O2Omulti Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2O2Omulti Blood Glucose Test Strips must be used with the AP-2Omulti Meter. It is intended for multi-patient use in 6 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-2O2Omulti Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2O2Omulti Blood Glucose Test Strips must be used the AP-2O2Omulti 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 11Control Solution is for use with AP-2Omulti meter and AP-2O2Oimulti Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K103116
Methodology: https://510kreport.com/methodology