# K103230: AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bestgen Biotech Corp.
- Decided: Apr 24, 2012 after 540 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 3.

## Indications for use
The AP-3000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary Whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. The AP-3000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control, It is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-3000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self.testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used with the AP-3000 Meter. The AP-3000 Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for use by lay users and should only be used by ai single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared, It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-3000 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes at home. AP-3000 Blood Glucose Test Strips must be used the AP-3000 Blood Glucose Meter The AP-3000 Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for uise by lay users and should only be used by a single patient as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared, It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. MAJOR Level I/Level 11Control Solution is for use with AP-3000 meter and AP-3000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. The AP-3000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. The AP-3000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-3000multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-3000multi Meter. AP-3000multi Meter is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-3000multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whore blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. AP-3000multi Blood Glucose Test Strips must be used with the AP-3000multi Meter. AP-3QO0multi Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. MAJOR Level I/Level 11Control Solution is for use with AP-3000multi meter and AP-3000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K103230
Methodology: https://510kreport.com/methodology