# K130332: Vitros Chemistry Products Trig Slides

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 31, 2013 after 109 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812029 (1981). 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)
- K812029: Kodak Ektachem Clin. Chem. Slides (Trig), Eastman Kodak Company (1981) Summary page 1.

## Most influential descendants
- K190490: VITROS XT Chemistry Products TRIG-CHOL Slides (2019), 0 descendants of its own

## Recalls of this device
- Aug 11, 2016 · Class II · Z-0091-2017: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, T
- Jun 12, 2013 · Class II · Z-0326-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K130332
Methodology: https://510kreport.com/methodology