# K161867: On Call Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Acon Laboratories
- Decided: Aug 5, 2016 after 29 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 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm and palm. The On Call Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices. The On call Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) should only be done during steady-state times (when glucese is not changing rapidly). The On Call Pro Blood Glucose Test Strips are used with the On Call Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.

Source page: https://510kreport.com/device/K161867
Methodology: https://510kreport.com/methodology