# K034000: Vitalab Triglycerides Reagent and Vitalab Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Mar 10, 2004 after 77 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Triglycerides Reagent Kit, product no. 445850: named in the summary without a submission number
- (no number) Synchron Multi-Calibrator, product no. 442600: named in the summary without a submission number

## Indications for use
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.

Source page: https://510kreport.com/device/K034000
Methodology: https://510kreport.com/methodology