# K130284: ON Call Sharp Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Dec 20, 2013 after 318 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: 2 generations back to K002134 (2000). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112653: ON Call Vivid Blood Glucose Monitoring Systems, ACON Laboratories, Inc. (2012) Summary page 1.

## Most influential descendants
- K181527: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System (2018), 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 Sharp Blood Glucose Monitoring System is Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and pal by people with diabetes at home as an aid in monitoring the effttivenicss of diabetes control programs. Alternative silo testing should be done only during steady-state times (when blood glucose level is not changing rapidly), The On Call Sharp Blood Glucose Monitoring System Is intended to be used by a single patient and should not be shared. It is for in vito diagnostic use only. The On Call Sharp Blood Glucose Monitoring System In not intended for the diagnosis of or sunening for diabetes. nor Intended for use on neonates. The On Call Sharp Blood Gluicse Test Strips are used with dhe On Call Sharp Blood Glucose Matr in the quantitative measurement of glucose in capillary blood from the fingertips, forearm anid palm." The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that thre ma'to and test strips ame working together properly end the test is performing correctly.

Source page: https://510kreport.com/device/K130284
Methodology: https://510kreport.com/methodology