# K012656: Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Sep 6, 2001 after 24 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: 2 generations back to K961828 (1996). 2 ancestors in all.
13 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)
- K980556: Liquichek Cardiac Markers Control LT, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K021498: Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel (2002), 12 descendants of its own
- 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

## Indications for use
An assayed quality control serum to monitor the precision cf laboratory teating procedures for analytes listed In the package insert.

Source page: https://510kreport.com/device/K012656
Methodology: https://510kreport.com/methodology