510(k) · Cleared
ClearedExtended Lipid Panel Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratory Corporation of America Holdings · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Oct 18, 2018 as substantially equivalent to K012286 (Roche Diagnostics Corp., 2001) and 3 other predicates after a 147-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 18, 2018
- Review
- 147 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K023158 (2002). 10 ancestors in all, the oldest K860894 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK023158 Randox Apolipoprotein CalibratorRandox Laboratories, Ltd. · 2002
- 2 generations backK041870 N Apolipoprotein Standard SerumDade Behring, Inc. · 2004
- 1 generation backK063608 Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1…Dade Behring, Inc. · 2007
- This deviceK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023158 | Randox Apolipoprotein Calibrator | Randox Laboratories, Ltd. | 2002 | — |
| −2 | K041870 | N Apolipoprotein Standard Serum | Dade Behring, Inc. | 2004 | — |
| −1 | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1… | Dade Behring, Inc. | 2007 | — |
| 0 (this device) | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K012286 | Modification to:Cobas Integra HDL-Cholesterol Plus 2ND GenerationSummary page 4…Clinical Chemistry (75) 5) Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Roche Diagnostics HDL-Cholesterol plus 2nd Generation - k012286 Roche Diagnostics COBAS Integra Cholesterol Gen.2 - k031824 Roche Diagnostics Triglycerides GPO Without Free Glycerol - k… | 2001 |
| * | K031824 | Cobas Integra Cholesterol Gen. 2Summary page 4…ch Equivalence is Claimed (Predicate Device) Roche Diagnostics HDL-Cholesterol plus 2nd Generation - k012286 Roche Diagnostics COBAS Integra Cholesterol Gen.2 - k031824 Roche Diagnostics Triglycerides GPO Without Free Glycerol - k873049 Dimension Vista Apolipoprotein B Flex reagent cartrid… | 2003 |
| * | K873049 | Triglycerides Gpo Without Free GlycerolSummary page 4…Cholesterol plus 2nd Generation - k012286 Roche Diagnostics COBAS Integra Cholesterol Gen.2 - k031824 Roche Diagnostics Triglycerides GPO Without Free Glycerol - k873049 Dimension Vista Apolipoprotein B Flex reagent cartridge - k063608 LabCorp… | 1987 |
| * | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Summary page 4…Integra Cholesterol Gen.2 - k031824 Roche Diagnostics Triglycerides GPO Without Free Glycerol - k873049 Dimension Vista Apolipoprotein B Flex reagent cartridge - k063608 LabCorp Page 8.1 Premarket Notification 510… | 2007 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 10 ancestors have a recall of any class.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and plasma, and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer. • Total Cholesterol measurements are used in the diagnosis and…
Read the full statement (147 words)
The Extended Lipid Panel Assay is an in vitro diagnostic test for quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human serum and plasma, and Apolipoprotein B in human serum. Values for Total Cholesterol, High Density Lipoprotein Cholesterol, Triglycerides and Apolipoprotein B are calculated by the Vantera® Clinical Analyzer.
• Total Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.
• High Density Lipoprotein Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
• Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181373: Extended Lipid Panel Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181373
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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