# K021513: Accu-Chek Advantage Module

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 11, 2002 after 33 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
No predicates in its family tree.
15 later devices descend from it; 8 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Accu-Chek Complete System: named in the summary without a submission number

## Most influential descendants
- K051285: Glucolab Blood Glucose Monitoring System (2005), 6 descendants of its own
- K091157: Gluco Lab Auto Coding, Model Igm-0022 (2009), 2 descendants of its own
- K113192: Healthpro Blood Glucose Monitoring System (2012), 1 descendant of its own
- K082201: G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A (2009), 1 descendant of its own
- K052469: Glucopack (2006), 1 descendant of its own

## Indications for use
The Accu-Chek Advantage Module 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/K021513
Methodology: https://510kreport.com/methodology