# K990649: Glucometer Elite XL Blood Glucose Meter, Glucometer Elite Blood Glucose Test Systems

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 9, 1999 after 130 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) GLUCOMETER ENCORE® QA+ Blood Glucose Test System: named in the summary without a submission number

## Indications for use
The GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blodd glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K990649
Methodology: https://510kreport.com/methodology