# K150300: Liquichek Cardiac Markers Plus Control LT

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Dec 11, 2015 after 308 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: 6 generations back to K961828 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus, Bio-Rad (2005) Summary page 4.

## Indications for use
Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. The following analytes are listed in the package insert: B-type Natriuretic Peptide (BNP) CK-MB Isoenzyme C-Reactive Protein (CRP) Creatine Kinase (CK) D-dimer Digitoxin Homocysteine Myeloperoxidase (MPO) Myoglobin N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Troponin I Troponin T

Source page: https://510kreport.com/device/K150300
Methodology: https://510kreport.com/methodology