# K982076: Amira Medical Atlast Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Amira Medical, Inc.
- Decided: Dec 10, 1998 after 181 days
- Product code: CGA (Glucose Oxidase, 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
Longest line of descent: 1 generation back to K922888 (1992). 2 ancestors in all.
34 later devices descend from it; 2 cite it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922888: One Touch Iib Blood Glucose Meter, Lifescan, Inc. (1992) Summary page 1.
- K923048: Accu-Chek Easy Blood Glucose System, Boehringer Mannheim Corp. (1992) Summary page 1.

## Most influential descendants
- K992684: Freestyle Blood Glucose Monitoring System (2000), 33 descendants of its own
- K012014: Modification to Blood Glucose Monitoring System (2001), 23 descendants of its own
- K020866: Freestyle Tracker Diabetes Management System (2002), 22 descendants of its own
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), 18 descendants of its own
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own

## Indications for use
The Amira Medical ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children). The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

Source page: https://510kreport.com/device/K982076
Methodology: https://510kreport.com/methodology