# K021498: Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 24, 2002 after 15 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- 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: 3 generations back to K961828 (1996). 3 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012656: Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648, Bio-Rad (2001) Summary page 1.
- K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688), Bio-Rad (1996) Summary page 1.

## Most influential descendants
- K040277: Liquichek Cardiac Marker Control LT (2004), 11 descendants of its own
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus (2005), 8 descendants of its own
- K123663: Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak (2012), 1 descendant of its own
- K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge (2012), 1 descendant of its own
- K112161: AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge.. (2012), 1 descendant of its own

## Indications for use
Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

Source page: https://510kreport.com/device/K021498
Methodology: https://510kreport.com/methodology
