# K991242: Glucometer Elite Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 30, 1999 after 79 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 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) GLUCOMETER ELITE® Test Strips: named in the summary without a submission number

## Most influential descendants
- K040848: EZ Smart (2004), 8 descendants of its own
- K052818: EZ Smart-168 Glucose Monitoring System (2006), 6 descendants of its own
- K062829: Diachex Blood Glucose Monitoring System (2006), 4 descendants of its own
- K073492: Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose Monitoring System (2008), 3 descendants of its own
- K090629: Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems (2009), 2 descendants of its own

## Indications for use
The GLUCOMETER ELITE® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K991242
Methodology: https://510kreport.com/methodology