510(k) · Cleared
Recalled · Class II · 2023Advia Chemistry Triglycerides_2 (Trig_2) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Nov 22, 2013 as substantially equivalent to K010871 (Dade Behring, Inc., 2001) after a 56-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 3 times.
- Decided
- Nov 22, 2013
- Review
- 56 days
- Class
- Class I
- Product code
- CDT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010871 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010871 TGL Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
- This deviceK133067 Advia Chemistry Triglycerides_2 (Trig_2) ReagentSiemens Healthcare Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010871 | TGL Flex Reagent Cartridge | Dade Behring, Inc. | 2001 | 1 |
| 0 (this device) | K133067 | Advia Chemistry Triglycerides_2 (Trig_2) Reagent | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CDT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010871 | TGL Flex Reagent CartridgeSummary page 2…valence Information: Predicate device name: Dimension Clinical Chemistry Triglycerides FLEX Reagent cartridge Predicate K number: k0 10871 Comparison with Predicate: Item New Device: Pred… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2023 | Class II | Z-1270-2023 | Under Investigation by firm | 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 | Device Design | 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 depressed results may occur on samples… |
| Mar 7, 2016 | Class II | Z-1670-2016 | Under Investigation by firm | 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 range as it approaches end of shelf life… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K010871.
How does its category compare?
All CDT devicesCDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CDT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · CDT
Too few CDT 510(k)s in any year since 2007 to give a median.
Recalls per year · CDT
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDT
12in 2025
MAUDE reports naming product code CDT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 0 | — | 3 | 12 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133067: Advia Chemistry Triglycerides_2 (Trig_2) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026