# K133067: Advia Chemistry Triglycerides_2 (Trig_2) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 22, 2013 after 56 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010871 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010871: TGL Flex Reagent Cartridge, Dade Behring, Inc. (2001) Summary page 2.

## Recalls of this device
- Jan 27, 2023 · Class II · Z-1270-2023: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
- Mar 17, 2016 · Class II · Z-1657-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre
- Mar 7, 2016 · Class II · Z-1670-2016: Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay ra

## Indications for use
For invitro diagnostic use in the quantitative measurement triglycerides in human serum or plasma on the ADVIA® Chemistry systems. Measurements obtained by this device 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/K133067
Methodology: https://510kreport.com/methodology