# K013342: Excelsior Test Strips, for Use with the Home Diagnostics, Inc.

- Pathway: 510(k) (Traditional)
- Applicant: Chay Medical, LLC
- Decided: Feb 15, 2002 after 129 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Source page: https://510kreport.com/device/K013342
Methodology: https://510kreport.com/methodology