# K061196: Cardioimmune XL Cardiac Marker Control

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 30, 2006 after 32 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- 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

## Recalls of this device
- Oct 20, 2014 · Class II · Z-0501-2015: MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
- Dec 14, 2011 · Not classified · Z-0637-2012: Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.

## Indications for use
Cardiolmmune®'XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

Source page: https://510kreport.com/device/K061196
Methodology: https://510kreport.com/methodology