# K012210: Modification to Accu-Chek Inform Meter

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 9, 2001 after 24 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Diagnostics Accu-Chek Advantage Meter: named in the summary without a submission number

## Recalls of this device
- Nov 19, 2004 · Not classified · Z-0372-05: A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
- Jun 30, 2004 · Not classified · Z-1060-04: Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
- Jun 30, 2004 · Not classified · Z-1061-04: Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

## Indications for use
The Accu-Chek Inform Meter is designed to quantitatively measure the concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus. The Accu-Chek Inform Meter is an addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter and Accu-Chek Complete Meter. The Accu-Chek Inform Meter is designed for use in conjunction with either the Accu-Chek Advantage or Accu-Chek Comfort Curve test strips.

Source page: https://510kreport.com/device/K012210
Methodology: https://510kreport.com/methodology