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 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.

Device Description

The Extended Lipid Panel Assay involves the acquisition of a 400 MHz proton NMR spectrum of serum or plasma, passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model. The proton NMR spectrum of serum and plasma is replete with information from the lipids packaged in lipoproteins. The spectrum consists of multiple proton signals emanating from the TG, cholesteryl esters and free cholesterol present in chylomicrons, VLDL, LDL and HDL, out of which the methylene and methyl proton signals are the most abundant. NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured. Using a PLS regression routine, the spectral information in the combined methylene and methyl region (0.56 - 1.40 ppm) was trained against the chemical measurements where the information is connected through latent variables. Cross-validation was performed with PRESS statistics to optimize the regression model with an appropriate number of latent variables. Once trained with sufficient number of specimens, for any test specimen spectrum, the spectral information is then converted into lipid or ApoB concentrations through the optimum number of 24 to 27 latent variables for which the regression coefficients were known from the predictor matrix.

AI/ML Overview

The Extended Lipid Panel Assay is an in vitro diagnostic test for the quantitative determination of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein B (ApoB) in human serum and plasma. The device uses Nuclear Magnetic Resonance (NMR) technology to derive analyte concentrations.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through various analytical performance studies. The document does not explicitly state pre-defined acceptance criteria in a dedicated table with pass/fail results against specific thresholds for each performance metric, but rather presents the results of these studies. Based on the provided performance data, the implicit acceptance criteria would be for the device to show good analytical sensitivity, precision, linearity, and minimal interference, and to demonstrate substantial equivalence to predicate devices through method comparison studies.

Below is a table summarizing the reported device performance, which implicitly demonstrates it meets the necessary criteria for "substantial equivalence" based on the FDA's assessment in the 510(k) clearance.

Performance Metric	Analyte	Reported Device Performance	Implicit Acceptance Standard (Inferred from predicates/regulatory guidance for clinical chemistry tests)
Analytical Sensitivity (LoQ)	TC	24 mg/dL	Lowest concentration measurable with acceptable precision and accuracy (implicitly deemed acceptable by FDA)
	TG	15 mg/dL	Lowest concentration measurable with acceptable precision and accuracy
	HDL-C	13 mg/dL	Lowest concentration measurable with acceptable precision and accuracy
	ApoB	18 mg/dL	Lowest concentration measurable with acceptable precision and accuracy
Within-run Precision (%CV) (n=20)	TC	0.9 - 1.6%	Low %CV indicating high within-run precision (typically < 5% or < 10% depending on analyte/concentration)
	TG	1.0 - 1.0%	Low %CV indicating high within-run precision
	HDL-C	1.3 - 2.4%	Low %CV indicating high within-run precision
	ApoB	1.1 - 1.2%	Low %CV indicating high within-run precision
Within-Laboratory Precision (%CV) (n=80)	TC	1.1 - 1.6%	Low %CV indicating high within-laboratory precision (typically < 5% or < 10%)
	TG	1.0 - 1.4%	Low %CV indicating high within-laboratory precision
	HDL-C	1.4 - 2.8%	Low %CV indicating high within-laboratory precision
	ApoB	1.9 - 2.4%	Low %CV indicating high within-laboratory precision
Reproducibility (%CV)	TC	2.1 - 3.6%	Low %CV across multiple sites/runs (typically < 10%)
	TG	2.1 - 3.4%	Low %CV across multiple sites/runs
	HDL-C	2.1 - 4.6%	Low %CV across multiple sites/runs
	ApoB	3.7 - 6.7%	Low %CV across multiple sites/runs
Linearity (R²)	TC	1.000	R² close to 1 indicates excellent linearity over the measuring range
	TG	1.000	R² close to 1 indicates excellent linearity over the measuring range
	HDL-C	1.000	R² close to 1 indicates excellent linearity over the measuring range
	ApoB	0.999	R² close to 1 indicates excellent linearity over the measuring range
Linearity (Measuring Range)	TC	66-868 mg/dL	Broad medically relevant measuring range
	TG	35-950 mg/dL	Broad medically relevant measuring range
	HDL-C	14-152 mg/dL	Broad medically relevant measuring range
	ApoB	35-366 mg/dL	Broad medically relevant measuring range
Interfering Substances	Endogenous/Exogenous	No significant interference observed for numerous agents at specified concentrations.	No clinically significant bias from common interferents.
Method Comparison (Correlation with Predicate)	TC	r = 0.994	High correlation (r > 0.975 typically sought) and Deming regression slope/intercept close to 1 and 0, respectively.
	TG	r = 0.9805 (implied from y= -3.858 + 0.9805x and visual)	High correlation
	HDL-C	r = 0.985	High correlation
	ApoB	r = 0.980	High correlation

2. Sample sizes used for the test set and the data provenance

Analytical Sensitivity (LoQ): Not specified how "LoQ" was determined by sample size, but indicates "lowest concentration measurable with acceptable precision and accuracy."
Assay Precision (Within-run and Within-laboratory): 20 replicates for within-run and 80 replicates (for n=80, it means 40 total runs over 20 days with 2 replicates per run on 1 instrument) for within-laboratory precision, using three patient serum pools (low, medium, high). The provenance is "patient serum pools."
Reproducibility: Five levels of serum panels were tested for 5 days, 6 runs per day, 2 replicates per run at 3 sites. This results in 5 (levels) * 5 (days) * 6 (runs/day) * 2 (replicates/run) * 3 (sites) = 900 measurements per analyte. The provenance is from "serum panels," presumably patient-derived.
Linearity: "Reference serum pools were prepared from patient specimens with low to high values" and "mean values from analysis of four replicates of each pool" were used. The exact number of 'pools' created for each analyte is not explicitly stated but implies multiple points across the range. The provenance is "patient specimens."
Interfering Substances: "samples with spiked concentrations of interferent" were used. The number of samples is not specified, but it covered "Eight endogenous agents and thirty drugs."
Method Comparison:
- TC: n=281 pooled serum samples
- TG: n=270 pooled serum samples
- HDL-C: n=15575 (This number seems exceptionally high compared to other n values; it might be a typo or represent cumulative data points over various experiments) pooled serum samples
- ApoB: n=266 pooled serum samples
  The data provenance for method comparison is "pooled serum samples across the reportable range" of the device. All studies appear to be retrospective using banked or prepared samples, as typical for analytical performance studies of this nature. The country of origin is not specified but is presumably the US given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a clinical chemistry assay for quantifying specific analytes (TC, TG, HDL-C, ApoB) rather than an imaging or diagnostic AI device that interprets qualitative information and requires human expert consensus for ground truth.

Ground Truth for Method Comparison: The "ground truth" for the method comparison studies was established by predicate clinical chemistry devices (biochemical assays like enzymatic colorimetric assay or nephelometric immunoassay). These are established methods that serve as the comparative standard. No human experts were involved in establishing the ground truth for the values themselves, as it's a quantitative measurement.
Qualifications of Experts: Not applicable in the context of establishing ground truth for quantitative chemical measurements. However, the development, validation, and regulatory submission would have been overseen by qualified scientists and regulatory affairs professionals.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative diagnostic devices where human interpretation might differ, and an expert panel resolves discrepancies to establish ground truth. For quantitative clinical chemistry assays, the reference method (predicate device in this case) provides the "adjudicated" ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are designed for evaluating diagnostic devices that involve human interpretation of images or other qualitative data, often with AI assistance, to assess the impact of AI on reader performance. This device is a standalone clinical chemistry analyzer that provides quantitative measurements; it does not involve human "readers" or AI assistance in a diagnostic interpretation workflow.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this device is inherently a standalone algorithm. The Extended Lipid Panel Assay is described as utilizing "passing the spectral information through a Partial Least Squares (PLS) regression model, and deriving analyte concentrations from the spectrum based on the trained PLS model." This process is entirely automated and does not involve human intervention in the result generation once the sample is run on the Vantera® Clinical Analyzer. The performance studies (precision, linearity, method comparison) directly evaluate this standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for evaluating the Extended Lipid Panel Assay was based on measurements obtained from legally marketed predicate clinical chemistry devices. These predicate devices are established methods for quantifying the specific lipid and lipoprotein analytes (TC, TG, HDL-C, ApoB).

8. The sample size for the training set

For the Partial Least Squares (PLS) regression model: "NMR spectra were recorded for several hundred to several thousand representative serum specimens for which the TG, TC, HDL-C and ApoB were chemically measured." The exact number is not precisely stated but indicates a substantial training dataset.

9. How the ground truth for the training set was established

The ground truth for the training set was established by chemical measurements (presumably using standard, often wet-chemistry or enzymatic reference methods) for TG, TC, HDL-C, and ApoB on the "several hundred to several thousand representative serum specimens." These chemical measurements served as the target values for the PLS regression model to learn the relationship between the NMR spectra and the analyte concentrations.

Summary

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October 18, 2018

Laboratory Corporation of America Holdings Suzette Warner Director, Quality Assurance and Regulatory Affairs 500 Perimeter Park Drive Morrisville, NC 27560

Re: K181373

Trade/Device Name: Extended Lipid Panel Assay Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation to the exemption 21 CFR 862.9 (c)(4) Product Code: CHH, CDT, LBS, MSJ Dated: September 12, 2018 Received: September 13, 2018

Dear Suzette Warner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. K

for Courtnev H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181373

Device Name Extended Lipid Panel Assay

Indications for Use (Describe)

· 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.

· Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary per 21CFR §807.92

1) 510(k) Number:

2) Submitted By

Laboratory Corporation of America Holdings 500 Perimeter Park Drive Morrisville, NC 27560 VTAC@labcorp.com

Contact Person: Suzette Warner Director, Quality Assurance and Regulatory Affairs LabCorp Ph: (919) 388-5539 warnes1@labcorp.com

3) Date Summary was Prepared:

October 1, 2018

4) Device Name(s)

Trade Name: Extended Lipid Panel Assay Common Name: Cholesterol Classification Names:

Triglyceride test system, 21 CFR 862.1705, Product Code CDT Cholesterol test system 21 CFR 862.1175, Product Code CHH Lipoprotein test system, 21 CFR 862.1475, Product Code LBS Lipoprotein test system, 21 CFR 862.1475, Product Code MSJ

Panel: 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 - K873049 Dimension Vista Apolipoprotein B Flex reagent cartridge - K063608

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6) Device Description

7) Indications for Use

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.

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8) Comparison to the Predicate

The proposed device, Extended Lipid Panel Assay, is substantially equivalent to the predicates (K012286, K031824, K873049, K013206). The substantial equivalence is supported by its similarity in its intended use, sample type, patient population and testing environment. The key features are summarized in the following tables:

	Total Cholesterol Assay(Predicate)	Extended Lipid Panel Assay(Proposed Device)
510(k) Number	K031824	K181373
Intended Use /Indications forUse	The cassette COBAS IntegraCholesterol Gen.2 (CHOL2)contains an in vitro diagnosticreagent system intended use foruse on COBAS Integra systemsfor the quantitativedetermination of totalcholesterol in serum andplasma.	The Extended Lipid Panel Assayis an in vitro diagnostic test forquantitative determination of TotalCholesterol, in human serum andplasma. Values are calculated bythe Vantera® Clinical Analyzer.
	Cholesterol measurements areused in the diagnosis andtreatment of disorders involvingexcess cholesterol in blood andlipid and lipoproteinmetabolism disorders.	Total Cholesterol measurementsare used in the diagnosis andtreatment of disorders involvingexcess cholesterol in the blood,lipid, and lipoprotein metabolismdisorders.
Technology	Enzymatic colorimetric assay	Nuclear magnetic resonance
Sample Type	Human Serum and Plasma	Human Serum and Plasma
Population	General	General
TestingEnvironment	Professional Use	Professional Use
Medical DecisionLimits	<200 and >240 mg/dL	<200 and >240 mg/dL
Sample size	2μL	150µL

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	HDL Cholesterol(Predicate)	Extended Lipid Panel Assay(Proposed Device)
510(k) Number	K012286	K181373
Intended Use /Indications forUse	The cassette COBAS IntegraHDL-Cholesterol plus 2ndGeneration (HDL-C) contains anin vitro diagnostic reagentsystem intended for use onCOBAS Integra systems for thequantitative determination ofHDL-cholesterol concentrationin serum and plasma.A lipoprotein test system is adevice intended to measurelipoprotein in serum and plasma.Lipoprotein measurements areused in the diagnosis andtreatment of lipid disorders (suchas diabetes mellitus),atherosclerosis and various liverand renal diseases.	The Extended Lipid Panel Assayis an in vitro diagnostic test forquantitative determination of HighDensity Lipoprotein Cholesterol(HDL-C), in human serum andplasma. Values are calculated bythe Vantera® Clinical Analyzer.High Density LipoproteinCholesterol measurements areused in the diagnosis andtreatment of lipid disorders (suchas diabetes mellitus),atherosclerosis, and various liverand renal diseases.
Technology	Enzymatic colorimetric assay	Nuclear magnetic resonance
Sample Type	Human Serum and Plasma	Human Serum and Plasma
Population	General	General
TestingEnvironment	Professional Use	Professional Use
Medical DecisionLimits	<40 and ≥60 mg/dL	<40 and ≥60 mg/dL
Sample size	2.5µL	150µL

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	Triglyceride(Predicate)	Extended Lipid Panel Assay(Proposed Device)
510(k) Number	K873049	K181373
Intended Use /Indications forUse	In vitro test for the quantitativedetermination of triglycerides inhuman serum and plasma.	The Extended Lipid Panel Assayis an in vitro diagnostic test forquantitative determination ofTriglycerides in human serum andplasma. Values are calculated bythe Vantera® Clinical Analyzer.
	The determination oftriglycerides is utilized in thediagnosis and treatment ofpatients having diabetes mellitus,nephrosis, liver obstruction, lipidmetabolism disorders andnumerous other endocrinediseases.	Triglyceride measurements areused in the diagnosis andtreatment of patients with diabetesmellitus, nephrosis, liverobstruction, other diseasesinvolving lipid metabolism, orvarious endocrine disorders.
Technology	Enzymatic colorimetric assay	Nuclear magnetic resonance
Sample Type	Human Serum and Plasma	Human Serum and Plasma
Population	General	General
TestingEnvironment	Professional Use	Professional Use
Medical DecisionLimits	<150 and >200 mg/dL	<150 and >200 mg/dL
Sample size	2uL	150μL

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	Apo B(Predicate)	Extended Lipid Panel Assay(Proposed Device)
510(k) Number	K063608	K181373
Intended Use /Indications forUse	An in vitro diagnostic test for thequantitative determination ofapolipoprotein B.	The Extended Lipid Panel Assayis an in vitro diagnostic test forquantitative determination ofApoB in human serum. Valuesare calculated by the Vantera®Clinical Analyzer.
	Measurements of apolipoproteinB aid in the diagnosis andtreatment of lipid disorders,various liver and renal diseases,and in the assessment of risk foratherosclerosis andcardiovascular disease.	Apolipoprotein B measurementsare used in the diagnosis andtreatment of lipid disorders andatherosclerosis
Technology	Nephelometric immunoassay	Nuclear magnetic resonance
Sample Type	Human Serum and Plasma	Human Serum
Population	General	General
TestingEnvironment	Professional Use	Professional Use
Medical DecisionLimits	<90 and >130 mg/dL	<90 and >130 mg/dL
Sample size	19.6μL	150μL

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9) Performance Data - Non-Clinical:

Analytical Sensitivity

The analytical sensitivity of the Extended Lipid Panel Assay was determined as the lowest concentration measurable with acceptable precision and accuracy. Limits of quantification (LoQ) are 24 mg/dL for TC, 15 mg/dL for TG, 13 mg/dL for HDL-C, and 18 mg/dL for ApoB.

Assay Precision

Within-run precision and within-laboratory precision were determined by testing 20 replicates of three patient serum pools in the same run and in 40 total different runs over 20 days on 1 instrument. The pools were analyzed according to EP-5A. The results of this testing are summarized below:

Within-run Precision (n=20)

	Low Pool			Medium Pool			High Pool
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
TC, mg/dL	159.3	2.6	1.6	196.3	2.6	1.3	275.8	2.6	0.9
TG, mg/dL	128.4	1.0	1.0	157.7	1.6	1.0	317.4	3.1	1.0
HDL-C,mg/dL	36.6	0.9	2.4	49.9	0.8	1.6	91.2	1.2	1.3
ApoB, mg/dL	76.7	0.9	1.2	105.5	1.1	1.1	133.8	1.4	1.1

Within-Laboratory Precision (n=80)

	Low Pool			Medium Pool			High Pool
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
TC, mg/dL	166.6	2.7	1.6	197.1	2.8	1.4	279.6	3.2	1.1
TG, mg/dL	130.6	1.8	1.4	160.9	1.9	1.2	320.3	3.1	1.0
HDL-C, mg/dL	36.7	1.0	2.8	49.3	1.2	2.3	91.7	1.3	1.4
ApoB, mg/dL	78.9	1.9	2.4	109.4	2.4	2.2	137.9	2.6	1.9

Reproducibility

A reproducibility study was conducted in accordance to EP5-A2 at 3 sites each having 1 instrument incorporating five levels of serum panels at or around the medical decision limits. The panels were tested for 5 days, 6 runs per day, 2 replicates per run. The overall precision estimates are described below.

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	Low Pool			Medium Pool			High Pool
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
TC, mg/dL	142	5.2	3.6	214	4.8	2.1	316	6.6	2.1
TG, mg/dL	107	3.7	3.4	170	5.1	3.0	296	6.2	2.1
HDL-C,mg/dL	36	1.7	4.6	52	2.2	4.2	80	2.4	2.1
ApoB, mg/dL	85	5.7	6.7	115	4.9	4.2	164	6.2	3.7

Precision from Reproducibility Study

Linearity

Reference serum pools were prepared from patient specimens with low to high values of TC, TG, HDL-C and ApoB as determined by the Extended Lipid Panel Assay. Each were mixed and diluted in different proportions to produce a range of different samples with widely varying target concentrations. Mean values from analysis of four replicates of each pool were compared to the expected target values to determine the percent bias for each sample. The serum pools were analyzed according to EP6-A. Regression plots of the linearity data for TC, TG, HDL-C and ApoB are given below:

TC Measuring Range: 66-868 mg/dL

Image /page/10/Figure/7 description: The image is a plot titled "TC Linearity Plot". The x-axis is labeled "Expected TC (mg/dL)" and ranges from 0 to 900. The y-axis is labeled "Measured TC (mg/dL)" and ranges from 0 to 900. A red line is plotted on the graph, and the equation for the line is "Y= 1.010x -1.851, R2= 1.000".

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TG Measuring Range: 35-950 mg/dL

Image /page/11/Figure/3 description: The image is a scatter plot titled "TG Linearity Plot". The x-axis is labeled "Expected TG (mg/dL)" and ranges from 0 to 1000. The y-axis is labeled "Measured TG (mg/dL)" and ranges from 0 to 1000. The plot shows a strong positive linear correlation between the expected and measured TG values, with the equation of the line being Y= 0.999x -1.086 and R^2= 1.000.

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HDL-C Measuring Range: 14-152 mg/dL

Image /page/12/Figure/3 description: The image is a plot titled "HDL-C Linearity Plot". The x-axis is labeled "Expected HDL-C (mg/dL)" and ranges from 0 to 160. The y-axis is labeled "Measured HDL-C (mg/dL)" and ranges from 0 to 160. The plot shows a linear relationship between the expected and measured HDL-C values, with the equation of the line being Y= 1.063x -1.925, R²= 1.000.

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Image /page/13/Figure/2 description: The image shows the measuring range for ApoB. The measuring range is from 35 to 366 mg/dL. The text is in bold font.

Image /page/13/Figure/3 description: The image is a scatter plot titled "ApoB Linearity Plot". The x-axis is labeled "Expected ApoB (mg/dL)" and ranges from 0 to 400. The y-axis is labeled "Measured ApoB (mg/dL)" and ranges from 0 to 400. The plot shows a linear relationship between the expected and measured ApoB values, with a regression equation of Y= 0.9853x -1.668 and an R-squared value of 0.999.

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Interfering Substances

Endogenous substances normally found in blood and exogenous substances (common and prescription drugs) were evaluated for potential interference with the Extended Lipid Panel Assay test results. Eight endogenous agents and thirty drugs were screened for potential interfering effects to Extended Lipid Panel Assay test using samples with spiked concentrations of interferent in accordance to CLSI EP7-A2 guidelines.

PotentialInterferent	HighestConcentrationTested (mg/dL)	Potential Interferent	HighestConcentrationTested (mg/dL)
Bilirubin, unconj.	20.	Atorvastatin	4.9
Bilirubin, conj.	34	Fenofibrate	4.5
Creatinine	5.5	Acetylsalicylic acid	66
Hemoglobin	219	Acetaminophen	20
Urea	263	Naproxen	28
Uric acid	24	Ibuprofen	44
Protein(albumin)	5986	Hydrochlorothiazide	0.65
Triglycerides(lipemic)	633	Metoprolol	1.5
		Nifedipine	0.04
		Enalaprilat	0.04
		Hydralazine	19
		Metformin	65
		Salicylic acid	61
		Clopidogrel	9.5
		Furosemide	6.3
		Glipizide	0.23
		Heparin	303533 mU/dL
		Isosorbide dinitrate	0.02
		Menhaden Oil	241
		Acetylcysteine	125

Ampicillin	6.1	Ascorbic Acid	6.2
Calcium Dobesilate	30	Cyclosporine	6.1
Cefoxitin	70	Levodopa(L-DOPA)	1.6
Methyldopa	1.6	Metronidazole	12
Doxycycline	3.1	Rifampin(Rifampicin)	34

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Endogenous			Exogenous (OTC drugs, etc.)
PotentialInterferent	HighestConcentrationTested(mg/dL)	PotentialInterferent	HighestConcentrationTested(mg/dL)	PotentialInterferent	HighestConcentrationTested(mg/dL)
Bilirubin,unconj.	20	Atorvastatin	4.9	Hydralazine	19
Bilirubin, conj.	34	Fenofibrate	4.5	Metformin	65
Creatinine	5.5	Acetylsalicylicacid	66	Salicylic acid	61
Hemoglobin	219	Acetaminophen	20	Clopidogrel	18
Urea	263	Naproxen	42	Furosemide	6.3
Uric acid	24	Ibuprofen	59	Glipizide	0.23
Protein(albumin)	5987	Hydrochlorothiazide	0.65	Heparin	303533 mU/dL
Triglycerides(lipemic)	500	Metoprolol	1.5	Isosorbidedinitrate	0.02
		Nifedipine	0.04	Menhaden Oil	241
		Enalaprilat	0.04

Substances tested in vitro that did not exhibit interference with TC test results.

Substances tested in vitro that did not exhibit interference with HDL-C test results.

Endogenous			Exogenous (OTC drugs, etc.)
PotentialInterferent	HighestConcentrationTested(mg/dL)	PotentialInterferent	HighestConcentrationTested(mg/dL)	PotentialInterferent	HighestConcentrationTested(mg/dL)
Bilirubin,unconj.	20	Atorvastatin	4.9	Hydralazine	19
Bilirubin, conj.	34	Fenofibrate	4.6	Metformin	65
Creatinine	5.5	Acetylsalicylicacid	66	Salicylic acid	61
Hemoglobin	219	Acetaminophen	20	Clopidogrel	18
Urea	263	Naproxen	28	Furosemide	6.3
Uric acid	24	Ibuprofen	44	Glipizide	0.23
Protein(albumin)	7493	Hydrochlorothiazide	0.65	Heparin	303533 mU/dL
Triglycerides(lipemic)	1135	Metoprolol	1.5	Isosorbidedinitrate	0.02
		Nifedipine	0.04	Menhaden Oil	242
		Enalaprilat	0.04

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Endogenous			Exogenous (OTC drugs, etc.)
PotentialInterferent	HighestConcentrationTested(mg/dL)	PotentialInterferent	HighestConcentrationTested (mg/dL)	PotentialInterferent	HighestConcentrationTested (mg/dL)
Bilirubin,unconj.	20	Atorvastatin	4.9	Hydralazine	19
Bilirubin, conj.	34	Fenofibrate	4.5	Metformin	65
Creatinine	5.5	Acetylsalicylic acid	66	Salicylic acid	61
Hemoglobin	219	Acetaminophen	20	Clopidogrel	18
Urea	263	Naproxen	56	Furosemide	6.3
Uric acid	24	Ibuprofen	29	Glipizide	0.23
Protein(albumin)	5987	Hydrochlorothiazide	0.65	Heparin	303533 mU/dL
		Metoprolol	1.5	Isosorbidedinitrate	0.02
		Nifedipine	0.04	Menhaden Oil	241
		Enalaprilat	0.04

Substances tested in vitro that did not exhibit interference with TG test results.

H. Method Comparison - Non-Clinical:

Method comparison was evaluated by using pooled serum samples across the reportable range of the Extended Lipid Panel Assay test for TC, TG, HDL-C and ApoB on the Vantera Clinical Analyzer. TC concentrations ranged from 71-859 mg/dL, TG concentrations ranged from 36 to 939.0 mg/dL, HDL-C concentrations ranged from 15 to 151.0 mg/dL and ApoB concentrations ranged from 36 to 344.0 mg/dL.

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Image /page/17/Figure/2 description: This image is a scatter plot comparing Vantera NMR TC to Predicate Device TC. The x-axis represents Predicate Device TC in mg/dL, ranging from 0 to 900, while the y-axis represents Vantera NMR TC, also ranging from 0 to 900. A Deming fit line is plotted with the equation y = 7.273 + 0.9737x, and the correlation coefficient r is 0.994. The plot also includes lines indicating the allowable difference of plus or minus 10 or 10% and a 95% confidence interval.

Vantera NMR (candidate device) vs. Predicate Device TC Regression Plot (n=281)

Vantera NMR (candidate device) vs. Predicate device TG Regression Plot (n=270)

Image /page/17/Figure/5 description: This image is a scatter plot comparing Vantera NMR TG values. The x and y axes both range from 0 to 1000. A Deming fit line is plotted with the equation y = -3.858 + 0.9805x, along with a 95% confidence interval and an allowable difference of ±10 or ±10%.

Predicate Device TG (mg/dL)

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Image /page/18/Figure/2 description: This image is a scatter plot comparing Vantera NMR HDL-C and Predicate Device HDL-C, both measured in mg/dL. The plot includes a Deming fit line represented by the equation y = 0.789 + 1x, with a correlation coefficient (r) of 0.985. The plot also shows lines indicating the allowable difference of plus or minus 10 or 10%, as well as 95% confidence intervals.

Vantera NMR (candidate device) vs. Predicate Device HDL-C Regression Plot (n=15575)

Vantera NMR (candidate device) vs. Comparator Device ApoB Regression Plot (n=266)

Image /page/18/Figure/5 description: The image is a scatter plot comparing Vantera NMR ApoB and Comparator Device ApoB, both measured in mg/dL. The plot includes a Deming fit line, represented by the equation y = -1.007 + 0.9699x, and a 95% confidence interval. The equation Y = 0.9699x - 1.007 and the correlation coefficient r = 0.980 are displayed on the plot, indicating a strong positive correlation between the two measurement methods. Allowable difference lines of plus or minus 10 or 10% are also shown.

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10) Conclusion:

The submitted information in this premarket notification provides the data necessary to demonstrate substantial equivalence based on analytical validations and predicate comparisons.

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1991 and the implementing regulation 21 CFR 807.92.

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.