# K062521: Oxalate Urine Controls (Normal and Elevated)

- Pathway: 510(k) (Traditional)
- Applicant: Thermo-Electron Corp.
- Decided: Mar 16, 2007 after 200 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 Oxalate Normal and Elevated Controls are for use in the quality control of the Thermo Oxalate method for the quantitative determination of urine oxalate. The control is used for monitoring accuracy and precision on automated clinical chemistry analysers and for manual operations. It is for in vitro diagnostic use only. The Oxalate Standard is intended for the calibration of Oxalate assays using the Thermo Oxalate Reagent. It is for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K062521
Methodology: https://510kreport.com/methodology