# K100437: AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bestgen Biotech Corp.
- Decided: Jan 12, 2012 after 694 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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 1.

## Indications for use
The AP-1000 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-1000 Blood Glucose Monitoring Systems is intended to be used by a single person and should not be shared. The AP-1000 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-1000 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-1000 Blood Glucose Test Strips must be used with the AP-1000 Meter. AP-1000 Meter is intended to be used by a single person and should not be shared. AP-1000 Meter is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-1000 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. AP-1000 Blood Glucose Test Strips must be used the AP-1000 Blood Glucose Meter. AP-1000 Blood Glucose Test Strips are intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-lOC0multi 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). The AP-lOC0multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing device. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-lOO0multi 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). AP-lOQ0multi Blood Glucose Test Strips must be used with the AP-lOO0multi Meter. AP-lOO0multi Meter is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP-iCO0multi 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). AP-lOO0multi Blood Glucose Test Strips must be used with the AP-iQO0multi Meter. AP-io00multi Blood Glucose Test Strips are intended for testing outside the body (in vitro diagnostic use) and are intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Source page: https://510kreport.com/device/K100437
Methodology: https://510kreport.com/methodology