# K021827: Modification to Accu-Chek Active System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 3, 2002 after 29 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945887 (1995). 15 ancestors in all.
1 later device descends 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)
- K021448: Modification to Accu-Chek Active System, Roche Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- K163087: PixoTest Blood Glucose Monitoring System (2017), 0 descendants of its own

## Recalls of this device
- May 13, 2009 · Not classified · Z-1591-2009: The lancet cap may be missing, which could result in an unintended lancet stick to the user.

## 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, calf and palm.

Source page: https://510kreport.com/device/K021827
Methodology: https://510kreport.com/methodology