# K123010: ON Call Vivid Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 14, 2012 after 78 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: 1 generation back to K002134 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.

## Indications for use
The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto-disabling lancing devices. The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger. The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K123010
Methodology: https://510kreport.com/methodology