# K060120: Teco CX3 Reagent Set for Synchron CX System

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Mar 27, 2006 after 69 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 K863926 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981106: Urea Nitrogen (Bun) Liquid Reagent, Teco Diagnostics (1998) Summary page 2.
- K864741: Cresolphthalein Complexone, Calcium, Tech-Co, Inc. (1987) Summary page 2.
- K880629: Creatinine, Tech-Co, Inc. (1988) Summary page 2.
- K863926: Glucose Oxidase, Tech-Co, Inc. (1986) Summary page 2.

## Indications for use
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K060120
Methodology: https://510kreport.com/methodology