# K192175: On Call Express II Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 17, 2019 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The On Call® Express II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly). The On Call® Express II Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Express II Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Express II Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

Source page: https://510kreport.com/device/K192175
Methodology: https://510kreport.com/methodology