# K111353: Accu-Check Combo System - Pathway: 510(k) (Abbreviated) - Applicant: Roche Diagnostics - Decided: Jul 17, 2012 after 428 days - Product code: LZG (Pump, Infusion, Insulin) - Device class: 2 - Regulation: 21 CFR 880.5725 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K010362 (2001). 10 ancestors in all. 37 later devices descend from it; 3 cite it directly. 1 of 48 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa, Disetronic Medical Systems AG (2006) Summary page 1. - K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System, Roche Diagnostics (2011). Cleared while this submission was under review Summary page 1. - K082595: Modification to:Accu-Chek Pocket Compass Diabetes Management Software, Roche Diagnostics (2008) Summary page 1. ## Most influential descendants - K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own - K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own - K160629: InPen (2016), 21 descendants of its own - K190487: InPen Dose Calculator (2020), 10 descendants of its own - K161433: Insulia Diabetes Management Companion (2016), 8 descendants of its own ## Recalls of this device - Apr 22, 2015 · Class II · Z-1733-2015: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin p - Sep 25, 2014 · Class II · Z-0146-2015: The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default sett - Oct 25, 2013 · Class II · Z-0385-2014: There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving ## Indications for use The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 3600 Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings. The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system. The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control, the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. For in vitro diagnostic use The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared. Source page: https://510kreport.com/device/K111353 Methodology: https://510kreport.com/methodology