# K021448: Modification to Accu-Chek Active System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 3, 2002 after 28 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: 4 generations back to K945887 (1995). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012324: Accu-Chek Active Test System, Roche Diagnostics Corp. (2001) Summary page 1.

## Most influential descendants
- 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. The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf

Source page: https://510kreport.com/device/K021448
Methodology: https://510kreport.com/methodology