# K160944: ACCU-CHEK Guide Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diabetes Care, Inc.
- Decided: Aug 31, 2016 after 148 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010362 (2001). 7 ancestors in all.
3 later devices descend from it; 3 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)
- K141867: Accu-Chek Aviva Connect Blood Glucose Monitoring System, Roche Diagnostics (2015) Summary page 5.
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 5.

## Most influential descendants
- K213131: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (2023), 0 descendants of its own
- K203711: IWL2020 Blood Glucose Monitoring System (2022), 0 descendants of its own
- K181131: Accu-Chek Guide Me Blood Glucose Monitoring System (2018), 0 descendants of its own

## Recalls of this device
- May 13, 2024 · Class II · Z-2174-2024: The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting
- Sep 30, 2019 · Class II · Z-0747-2020: Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.

## Indications for use
The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips. The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K160944
Methodology: https://510kreport.com/methodology