# K971324: Triglycerides, TG, or Trig

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: Jun 20, 1997 after 71 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls (2008), 4 descendants of its own
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), 2 descendants of its own
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K210801: AXINON® LDL-p Test System (2023), 0 descendants of its own
- K133849: Vantera Clinical Analyzer (2014), 0 descendants of its own

## Indications for use
The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical Systems. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.

Source page: https://510kreport.com/device/K971324
Methodology: https://510kreport.com/methodology