510(k) · Cleared
ClearedVantera Clinical Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liposcience · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Aug 30, 2012 as substantially equivalent to K111516 (Liposcience, Inc., 2011) and 1 other predicate after a 247-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Aug 30, 2012
- Review
- 247 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971573 (1997). 7 ancestors in all, the oldest K971162 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- 3 generations backK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
- 2 generations backK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- 1 generation backK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
- This deviceK113830 Vantera Clinical AnalyzerLiposcience · 2012
- Descendant · cites it directly · 0 of its ownK133849 Vantera Clinical AnalyzerLiposcience · 2014
Most influential descendants
Showing 1 of 1 · See all- K133849Vantera Clinical AnalyzerLiposcience · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| −3 | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 | Dade Behring, Inc. | 2002 | — |
| −2 | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| −1 | K111516 | NMR Lipoprofile (R) Test and NMR Profiler | Liposcience, Inc. | 2011 | — |
| 0 (this device) | K113830 | Vantera Clinical Analyzer | Liposcience | 2012 | — |
| +1 | K133849 | Vantera Clinical Analyzer | Liposcience | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K111516 | NMR Lipoprofile (R) Test and NMR ProfilerSummary page 1…Clinical Chemistry (75) D. Legally Marketed Device to which Equivalence is Claimed (Predicate Device): NMR Profiler and NMR Lipoprofile test k1 11516 Luminex LX 100/200 Instrument k073506 LipoScience, Inc.… | 2011 |
| * | K073506 | Luminex LX 100/200 InstrumentSummary page 1…quivalence is Claimed (Predicate Device): NMR Profiler and NMR Lipoprofile test k1 11516 Luminex LX 100/200 Instrument k073506 LipoScience, Inc. Page 6.1 Premnarket No… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133849 | Vantera Clinical Analyzer | 2014 | 0 |
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K133849 (Liposcience, 2014) has gone furthest, with 0 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. 2012, 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?
The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from…
Read the full statement (140 words)
The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples.
The NMR LipoProfile test, when used with the Vantera® Clinical Analyzer, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113830: Vantera Clinical Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113830
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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