# K022171: Accu-Chek Compact System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 23, 2002 after 20 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K004010 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004010: Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact Compact Controls, Roche Diagnostics Corp. (2001)

## Most influential descendants
- 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
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own

## Recalls of this device
- May 18, 2005 · Not classified · Z-0976-05: The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is ben
- May 18, 2005 · Not classified · Z-0977-05: The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is ben

## Indications for use
The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.

Source page: https://510kreport.com/device/K022171
Methodology: https://510kreport.com/methodology