# K180196: On Call Express Mobile Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Mar 7, 2018 after 42 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 Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly) The On Call® Express Mobile 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 Mobile 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 Mobile Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

Source page: https://510kreport.com/device/K180196
Methodology: https://510kreport.com/methodology