# K040880: Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Apr 28, 2004 after 23 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K122291: Thermo Scientific Mas Omni-Cardio (2012), 0 descendants of its own

## Indications for use
The MAS® Cardionmmune ~ TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product with patient serum specimens when assaying for any of the listed constituents. Assay values arc 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/K040880
Methodology: https://510kreport.com/methodology