510(k) · Cleared
ClearedTriglycerides, TG, or Trig
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carolina Liquid Chemistries Corp. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Jun 20, 1997 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 71 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK971324 Triglycerides, TG, or TrigCarolina Liquid Chemistries Corp. · 1997
- Descendant · cites it directly · 4 of its ownK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- Descendant · 2 generations on · 2 of its ownK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK113830 Vantera Clinical AnalyzerLiposcience · 2012
- Descendant · 2 generations on · 0 of its ownK210801 AXINON® LDL-p Test SystemNumares AG · 2023
- Descendant · 4 generations on · 0 of its ownK133849 Vantera Clinical AnalyzerLiposcience · 2014
Most influential descendants
Showing 5 of 5 · See all- K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008 · cites it directly4descendants
- K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011 · 2 generations on2descendants
- K113830Vantera Clinical AnalyzerLiposcience · 2012 · 3 generations on1descendant
- K210801AXINON® LDL-p Test SystemNumares AG · 2023 · 2 generations on0descendants
- K133849Vantera Clinical AnalyzerLiposcience · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971324 | Triglycerides, TG, or Trig | Carolina Liquid Chemistries Corp. | 1997 | — |
| +1 | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| +2 | K111516 | NMR Lipoprofile (R) Test and NMR Profiler | Liposcience, Inc. | 2011 | — |
| +3 | K113830 | Vantera Clinical Analyzer | Liposcience | 2012 | — |
| +2 | K210801 | AXINON® LDL-p Test System | Numares AG | 2023 | — |
| +4 | K133849 | Vantera Clinical Analyzer | Liposcience | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | 2008 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063841 (Liposcience, 2008) has gone furthest, with 4 descendants of its own.
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.
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?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971324: Triglycerides, TG, or Trig.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971324
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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