# K130138: Super Sani-Cloth/ Accu-Chek Inform II System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 15, 2013 after 56 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010362 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121679: Accu-Chek Inform II Blood Glucose Monitoring System, Roche Diagnostics (2012) Summary page 1.

## Indications for use
The ACCU-CHEK Inform IHTest strip is for use with the ACCU-CHEK Inform 11 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 11 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 11 Controls are intended for quality control performance checks on the ACCU-CHEK Inform It system with ACCU-CHEK Inform 11 test strips. The ACCU-CHEK Inform 11 Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform It system using ACCU-CHEK Inform 11 test strips.

Source page: https://510kreport.com/device/K130138
Methodology: https://510kreport.com/methodology