# K011738: Accu-Chek Active System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 20, 2001 after 15 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices 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) Accu-Chek Simplicity System: named in the summary without a submission number

## Most influential descendants
- K060706: Liberty Normal Glucose Control Solution (2006), 8 descendants of its own
- K070506: SMS Multi Glucose Control, Model 2120049 (2007), 5 descendants of its own
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek (2008), 2 descendants of its own
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (2013), 1 descendant of its own
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 (2008), 1 descendant of its own

## Indications for use
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

Source page: https://510kreport.com/device/K011738
Methodology: https://510kreport.com/methodology