# K181527: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 3, 2018 after 114 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: 3 generations back to K002134 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130284: ON Call Sharp Blood Glucose Monitoring System, ACON Laboratories, Inc. (2013) Summary page 5.

## Most influential descendants
- K200277: Livongo Blood Glucose Monitoring System (BG1000) (2020), 0 descendants of its own

## Indications for use
The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure 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 palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync 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 palm. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K181527
Methodology: https://510kreport.com/methodology