# K030942: Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Apr 28, 2003 after 33 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K092051: Thermo Scientific Mas  Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158 (2009), 1 descendant of its own
- K110738: Thermo Scientific Mas Omni-Core (2011), 0 descendants of its own
- K050983: Irma Trupoint Creatinine Control Kit (2005), 0 descendants of its own

## Indications for use
The MAS® chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. The DADE® Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trol® H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Source page: https://510kreport.com/device/K030942
Methodology: https://510kreport.com/methodology