# K043311: Ascensia Elite Diabetes Care System

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 22, 2004 after 21 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: 1 generation back to K964630 (1997). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020208: Glucometer Elite Diabetes Care System (Modified), Bayer Group Diagnostics (2002) Summary page 1.
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 1.

## Most influential descendants
- K062538: Easy Check Blood Glucose Monitoring System (2007), 6 descendants of its own
- K090389: AP-1000 Blood Glucose Monitoring System (2009), 4 descendants of its own
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 (2008), 1 descendant of its own
- K123966: Glucose Meter-Check Solution for Bayer (2013), 0 descendants of its own
- K103230: AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution (2012), 0 descendants of its own

## Indications for use
The Ascensia ELITE Blood Glucose Meter is used with Ascensia ELITE Blood Glucose Test Strips, and Ascensia ELITE Controls for the measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The Ascensia ELITE Diabetes Care System is an Over-The-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K043311
Methodology: https://510kreport.com/methodology