# K112653: ON Call Vivid Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Apr 9, 2012 after 210 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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.
7 later devices descend from it; 3 cite it directly.
0 of 9 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.

## Most influential descendants
- K130284: ON Call Sharp Blood Glucose Monitoring System (2013), 3 descendants of its own
- K181527: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System (2018), 1 descendant of its own
- K132086: ON Call Express Blood  Glucose Monitoring System (2013), 1 descendant of its own
- K193340: GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System (2020), 0 descendants of its own
- K200277: Livongo Blood Glucose Monitoring System (BG1000) (2020), 0 descendants of its own

## Indications for use
The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm 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®) Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. It is for in vitro diagnostic use only. The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use. The On Call® Vivid Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in fresh capillary blood from the fingertip, forearm, and palm. The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid Blood Glucose Meter and Test 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/K112653
Methodology: https://510kreport.com/methodology