# K993829: Accu-Chek Simplicity System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 9, 1999 after 27 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K971876: Accu-Chek Simplicity Test Strip. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3.

## Most influential descendants
- K014167: Liberty Blood Glucose Monitoring System (2002), 0 descendants of its own

## Indications for use
The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Source page: https://510kreport.com/device/K993829
Methodology: https://510kreport.com/methodology