# K991480: Excel GE Blood Glucose Test Strips & Code Strip

- Pathway: 510(k) (Traditional)
- Applicant: Selfcare, Inc.
- Decided: Sep 17, 1999 after 142 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 K924499 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964630: Glucometer Elite Blood Glucose Meter, Bayer Corp. (1997) Summary page 1.
- K951537: Glucometer Elite M Blood Glucose Meter, Bayer Corp. (1995) Summary page 1.
- K924499: Elite Test Strips Glucometer, Heraeus Kulzer, Inc. (1992) Summary page 1.

## Indications for use
Excel™ GE Blood Glucose Test Strips quantitatively measure glucose in fresh capillary whole blood and give results that are comparable to laboratory methods. They are intended for in vitro diagnostic (external) use by people with diabetes for self-monitoring of blood glucose. The Excel™ GE Blood Glucose Test Strips are designed to be used with Glucometer Elite® Blood Glucose Meters only.

Source page: https://510kreport.com/device/K991480
Methodology: https://510kreport.com/methodology