# K031441: Urichemtrak Liquid Assayed Urine Control

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Jul 1, 2003 after 56 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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
MAS@UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. Bayer Urine Control For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS@

Source page: https://510kreport.com/device/K031441
Methodology: https://510kreport.com/methodology