ACCU-CHECK COMBO SYSTEM— 510(k) K111353

Clearance details

Applicant

Roche Diagnostics

Product code

Code LZG

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2011-05-16

Decision date

2012-07-17

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Indianapolis, IN, US

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• K260046 — Elecsys Anti-HBc II2026-04-07
• K260048 — Elecsys Anti-HAV IgM2026-04-07

Death

104

Injury

12,022

Malfunction

135,004

Other

1

Total

147,131

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1733-2015 — AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.Class II·Terminated·Roche Diabetes Care, Inc.·20150422
• Z-0146-2015 — ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It 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.Class II·Terminated·Roche Diagnostics Operations, Inc.·20140925
• Z-0385-2014 — ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ 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.Class II·Terminated·Roche Diagnostics Operations, Inc.·20131025

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111353.