# K090389: AP-1000 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bestgen Biotech Corp.
- Decided: Jul 14, 2009 after 147 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: 3 generations back to K964630 (1997). 4 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062538: Easy Check Blood Glucose Monitoring System, Diacare Corp. (2007) Summary page 1.

## Most influential descendants
- K103230: AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution (2012), 0 descendants of its own
- K103116: AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System (2012), 0 descendants of its own
- K103044: AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control Solution (2012), 0 descendants of its own
- K100437: AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control Solution (2012), 0 descendants of its own

## Indications for use
The AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, 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-1000 Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-.1 000 Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The AP-1000 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. MAJOR Level I/Level II Control Solution are for use with the AP-1000 meter and AP-1000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K090389
Methodology: https://510kreport.com/methodology