# K122110: Acon on Call Vivid Pal Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Nov 21, 2012 after 127 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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 Callo Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the, fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call@ Vivid Blood Pal 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 Vivid Blood Pal Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates. The On Call Vivid Pal Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm. The On Call Vivid Pal Blood Glucose Control Solution is for use with the On Call Vivid Pal Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K122110
Methodology: https://510kreport.com/methodology