# K012324: Accu-Chek Active Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 5, 2001 after 135 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 K945887 (1995). 13 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.
- K001993: Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control Solutions, Abbott Laboratories (2000) Summary page 1.
- K992684: Freestyle Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2000) Summary page 1.
- K001427: Modification to Fasttake Compact Blood Glucose Monitoring System, Selfcare, Inc. (2000) Summary page 1.

## Most influential descendants
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek (2008), 2 descendants of its own
- K021448: Modification to Accu-Chek Active System (2002), 2 descendants of its own
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (2013), 1 descendant of its own
- K021827: Modification to Accu-Chek Active System (2002), 1 descendant of its own
- K163087: PixoTest Blood Glucose Monitoring System (2017), 0 descendants 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/K012324
Methodology: https://510kreport.com/methodology