# K113137: Glucose Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Jan 6, 2012 after 74 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: 4 generations back to K010362 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System, Roche Diagnostics (2011) Summary page 1.

## Recalls of this device
- Jul 28, 2021 · Class II · Z-2353-2021: 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
- Mar 16, 2021 · Class II · Z-1942-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Mar 12, 2012 · Not classified · Z-1386-2012: Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through e

## Indications for use
The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The ACCU-CHEK SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Source page: https://510kreport.com/device/K113137
Methodology: https://510kreport.com/methodology