# K970976: Cardioimmune Cardiac Marker Control, Levels 1,2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Apr 2, 1997 after 16 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 K961828 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688), Bio-Rad (1996) Summary page 1.

## Indications for use
Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations.

Source page: https://510kreport.com/device/K970976
Methodology: https://510kreport.com/methodology