ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K121679

Name: FDA 510(k) clearance K121679
Creator: U.S. Food and Drug Administration
Published: 2012-10-11

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K121679 for ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-10-11. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code NBW
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2012-06-07
Decision date: 2012-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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 →

Recalls naming K121679

K-number listed on FDA's recall record

Z-2354-2021 — Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001Class II·Ongoing·Roche Diabetes Care, Inc.·20210728
Z-1172-2016 — Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.Class II·Terminated·Roche Diagnostics Operations, Inc.·20160211
Z-1113-2013 — ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).Class II·Terminated·Roche Diagnostics Operations, Inc.·20130306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121679.

Data sourced from openFDA. This site is unofficial and independent of the FDA.