510(k) · Cleared
ClearedElitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seppim S.A.S. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on May 19, 2011 as substantially equivalent to K060854 (Horiba Abx, 2006) and 2 other predicates after a 223-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 19, 2011
- Review
- 223 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K933930 (1994). 21 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 4 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 3 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 2 generations backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- 1 generation backK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
- This deviceK102993 Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems…Seppim S.A.S. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −4 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −3 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −2 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| −1 | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | 2 |
| 0 (this device) | K102993 | Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems… | Seppim S.A.S. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K060854 | Abx Pentra 400: LipoproteinsSummary page 1…t system (Sec.862.1705) Product code CDT - Lipase Hydrolysis/Glycerol kinase enzyme, Triglycerides Predicate device ABX PENTRA TRIGLYCERIDES CP (K060854) Device description The device for this submission is available as kit only. It consists of 1… | 2006 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 6…1150) Product code JIX- Calibrator, multi-analyte mixture Predicate device Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) Device description ELiTech Clinical Systems ELICAL 2 is a lyophilized calibrator based on… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 7…862.1660) Product code JJY Multi-analyte controls - all kinds Predicate device Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U (K041227) Device description ELITech… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- 2 other devices also cite its predicate K060854.
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. 2011, 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?
ELiTech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELiTech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nelphrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine…
Read the full statement (182 words)
ELiTech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELiTech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nelphrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
ELiTech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers.
ELiTech Clinical Systems ELITROL I & ELITROL 11are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102993: Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102993
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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