# K092051: Thermo Scientific Mas  Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Sep 21, 2009 after 76 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
Longest line of descent: 1 generation back to K030942 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030942: Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control, Medical Analysis Systems, Inc. (2003) Summary page 2.
- (no number) MAS® chemTRAK® H: named in the summary without a submission number
- (no number) DADE® Moni-Trol® H: named in the summary without a submission number

## Most influential descendants
- K110738: Thermo Scientific Mas Omni-Core (2011), 0 descendants of its own

## Indications for use
chemTRAK ® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum 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 instrument. 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 Moni-Trol ® H with patient serum 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 instrument.

Source page: https://510kreport.com/device/K092051
Methodology: https://510kreport.com/methodology