# K121679: Accu-Chek Inform II Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 11, 2012 after 126 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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: 2 generations back to K010362 (2001). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003846: Accu-Chek Inform Meter, Roche Diagnostics Corp. (2001) Summary page 1.
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.
- K060345: Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions, Nova Biomedical Corp. (2006) Summary page 1.

## Most influential descendants
- K133741: ACCU-CHEK Performa Blood Glucose Monitoring System (2014), 3 descendants of its own
- K170079: Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System (2017), 2 descendants of its own
- K182046: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (2018), 0 descendants of its own
- K182047: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (2018), 0 descendants of its own
- K130138: Super Sani-Cloth/ Accu-Chek Inform II System (2013), 0 descendants of its own

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2354-2021: Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentiall
- Feb 11, 2016 · Class II · Z-1172-2016: Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to th
- Mar 6, 2013 · Class II · Z-1113-2013: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barco

## Indications for use
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The 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 used with single-use, auto-disabling lancing devices. The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips. The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.

Source page: https://510kreport.com/device/K121679
Methodology: https://510kreport.com/methodology