# K983344: Dade Behring Quiklyte Metabolyte Cartridge, Model Dimension (R) XL or RXL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 22, 1999 after 272 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) FLEX reagent cartridges: named in the summary without a submission number

## Indications for use
Glucose Measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Urea Nitrogen Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K983344
Methodology: https://510kreport.com/methodology