# K012243: MCC Uricheck Assayed Liquid Urine Multiconstituent Control

- Pathway: 510(k) (Traditional)
- Applicant: Hematronix, Inc.
- Decided: Aug 20, 2001 after 34 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent quality control material for use in the clinical laboratory environment. MCC™ URICHECK™ is intended to monitor the precision and accuracy of instrument and reagent methods when run as a patient sample and is ready to use. Expected ranges used in the monitoring of quantitative constituents, qualitative methods and physical properties of MCC™ URICHECK™ can be found on the package insert for routine chemistry analysis.

Source page: https://510kreport.com/device/K012243
Methodology: https://510kreport.com/methodology