# K981622: Dade Tru-Liquid Cardiac Control

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 8, 1998 after 32 days
- Product code: JJX (Single (Specified) Analyte 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: 1 generation back to K961828 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K982591: Dade Tru-Liquid Cardiac Control (1998), 0 descendants of its own

## Indications for use
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.

Source page: https://510kreport.com/device/K981622
Methodology: https://510kreport.com/methodology