The NMR LipoProfile® test, when used with the NMR Profiler, 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. This test is performed and provided as a service by LipoScience Laboratory.

Device Description

The NMR LipoProfile® test and NMR Profiler involves measurement of the 400 MHz proton NMR spectrum of a plasma/serum sample, deconvolution of the composite signal at approximately 0.8 ppm to produce signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma/serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The ~0.8 ppm plasma NMR signal arises from the methyl group protons of the lipids carried in the LDL, HDL and VLDL subclasses of varying diameters. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which is accounted for in the deconvolution analysis model. Each subclass signal amplitude is proportional to the number of subclass particles emitting the signal, which enables subclass particle concentrations to be calculated from the subclass signal amplitudes derived from the spectral deconvolution analysis. LDL subclass particle concentrations, in units of nanomoles of particles per liter (nmol/L), are summed to give the reported total LDL particle concentration (LDL-P). By employing conversion factors assuming that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document focuses on analytical performance rather than clinical acceptance criteria. The acceptance criteria for the analytical evaluation (sensitivity, precision, linearity, and method comparison) are largely implied through the reported performance metrics and the use of CLSI guidelines. The document does not explicitly state pre-defined acceptance criteria values for bias or CVs in a standalone table, but rather presents the reported performance data.

Table 1: Acceptance Criteria and Reported Device Performance (Analytical)

Performance Metric	Analyte	Acceptance Criteria (Implied)	Reported Device Performance
Analytical Sensitivity (LOQ)	LDL-P	Lowest concentration with acceptable precision and accuracy (Total error ≤20%)	300 nmol/L
	HDL-C	Lowest concentration with acceptable precision and accuracy (Total error ≤20%)	10 mg/dL
	Triglycerides	Lowest concentration with acceptable precision and accuracy (Total error ≤20%)	25 mg/dL
Within-run Precision (%CV)	LDL-P	(Not explicitly stated, but typical for diagnostic assays)	3.7% - 5.0%
	HDL-C	(Not explicitly stated)	0.9% - 2.0%
	Triglycerides	(Not explicitly stated)	1.3% - 2.6%
Within-laboratory Precision (%CV)	LDL-P	(Not explicitly stated)	4.3% - 7.7%
	HDL-C	(Not explicitly stated)	1.8% - 3.3%
	Triglycerides	(Not explicitly stated)	2.5% - 3.6%
Linearity (Measuring Range)	LDL-P	(Not explicitly stated, but implied to be within acceptable non-linearity goal)	300-3500 nmol/L
	HDL-C	(Not explicitly stated, but implied to be within acceptable non-linearity goal)	7-140 mg/dL
	Triglycerides	(Not explicitly stated, but implied to be within acceptable non-linearity goal)	5-1100 mg/dL
Method Comparison (Correlation with Predicate)	LDL-P	Strong positive correlation (e.g., r > 0.95 or 0.97)	r = 0.970
	HDL-C	Strong positive correlation (e.g., r > 0.95 or 0.99)	r = 0.999
	Triglycerides	Strong positive correlation (e.g., r > 0.95 or 0.99)	r = 1.00
Interfering Substances	Endogenous agents & exogenous drugs	No significant interference	Tested (results not detailed, but implied acceptable)

Study Details

The provided text describes analytical performance studies designed to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:

Analytical Sensitivity (LOQ): "20 replicates of each were analyzed" for serially diluted serum specimens with low concentrations. The number of unique patient samples used for initial dilution is not specified.
Assay Precision:
- Within-run: 20 replicates of three patient serum pools.
- Within-laboratory: 20 different runs over 20 days using three patient serum pools (n=80 for each pool across runs).
Linearity: Four replicates of each of eleven (for LDL-P) or twelve (for TG and HDL-C) different samples derived from three serum pools.
Method Comparison:
- LDL-P: n=1555 serum samples
- HDL-C: n=1599 serum samples
- Triglycerides: n=1597 serum samples
Interfering Substances: "Five endogenous agents and twenty two drugs were screened". No sample size for patient samples is given, but likely spiked samples.

Data Provenance: The document does not explicitly state the country of origin. The samples are described as "patient serum pools" and "serum samples," implying they are from human subjects, likely in a clinical laboratory setting. The terms "retrospective" or "prospective" are not used; these appear to be analytical validation studies on collected samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these analytical studies is based on quantitative measurements (e.g., predicate device measurements for method comparison, or target values established through dilution for linearity and sensitivity). This is not an image-based or clinical diagnostic study requiring expert interpretation.

4. Adjudication method for the test set: Not applicable. These are quantitative analytical studies, not studies requiring expert adjudication of results.

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. This is an analytical device for quantifying lipoprotein particles, not an AI-assisted diagnostic imaging device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the entire performance data section (Analytical Sensitivity, Assay Precision, Linearity, Interfering Substances, Method Comparison) represents standalone algorithm performance, as the device is an automated NMR spectrometer with deconvolution software. There is no human interpretation or intervention in the measurement process itself.

7. The type of ground truth used:

Analytical Sensitivity (LOQ): Target values from serial dilution.
Assay Precision: Mean values from repeated measurements of serum pools.
Linearity: Expected target values derived from mixing and diluting serum pools.
Method Comparison: Measurements from the legally marketed predicate device (NMR Profiler and NMR Lipoprofile Assay, K063841).
Interfering Substances: Pre-established target concentrations of potential interferents.

8. The sample size for the training set: Not applicable. This is an analytical device validation, not a machine learning model that undergoes a distinct training phase in the context of this 510(k) submission. The underlying deconvolution software likely had development and calibration phases, but those are not described as a "training set" in this document.

9. How the ground truth for the training set was established: Not applicable, as no training set is explicitly described for this 510(k) submission.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

NMR LipoProfile® test and NMR Profiler

510(k) SUMMARY

C LIVOSCIENCE

SEP 2 7 2011

510(k) Number: K111516 A.

Submitter Contact Information: B.

Submitter:

LipoScience, Inc. 2500 Sumner Boulevard Raleigh, NC 27616 Ph: (919) 256-1326 Fax: (919) 256-1149

Contact Person:

Suzette Warner Manager, Regulatory Affairs LipoScience, Inc. Ph: (919) 256-1326 Fax: (919) 256-1149 Suzette. Warner@liposcience.com

C. Device Name:

NMR LipoProfile® test and NMR Profiler Trade Name: NMR LipoProfile test and NMR Profiler Common Name: Classification Names: Lipoprotein test system, 21 CFR 862.1475, Product Code MRR and LBS Cholesterol test system 21 CFR 862.1175, Product Code LBS Triglyceride test system, 21 CFR 862.1705, Product Code CDT Quality Control material, 21 CFR 862.1660, Product Code JJY Calibrator, 21 CFR 862.1150, Product Code JIT Clinical Chemistry (75) Panel:

Legally Marketed Device to which Equivalence is Claimed (Predicate Device): D.

NMR Profiler and NMR Lipoprofile Assay, K063841

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E. Device Description:

SPECIMEN

Types of Specimen

Freshly drawn serum collected in the NMR LipoTube (manufactured by Greiner, Inc. Part #456293) is the preferred specimen. Freshly drawn serum collected in plain red-top blood collection tubes and plasma collected in EDTA or heparin tubes are also acceptable specimens. Serum or plasma specimens drawn in gel barrier collection tubes other than the NMR LipoTube are unsuitable for analysis and should not be used. The optimum specimen volume is ≥0.5 mL. Patient fasting is not necessary prior to the blood draw, except for determination of fasting triglyceride concentrations.

Specimen Storage and Stability

Specimens collected in the NMR LipoTube should be held upright at room . temperature for 20 to 30 minutes and allowed to clot and then refrigerated at 2-8°C. The specimens should be centrifuged within 24 hours of collection and then stored in the original collection tube at 2-8°C for up to 5 days prior to testing.
It is recommended that blood samples be centrifuged within 6 hours of collection . and the serum or plasma removed to a transfer tube and stored at 2-8℃ for up to 5 days prior to testing.
. Serum or plasma should not remain at room temperature longer than 6 hours. If assays are not completed within 6 hours, specimens should be stored at 2-8℃ for up to 5 days prior to testing.
Serum or plasma specimens are stable for up to 5 days at 2-8℃. Samples may be . frozen at -80℃ for up to 5 days prior to testing.

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REAGENTS AND MATERIALS

Diluent 1 (NMR LipoProfile® test) aqueous solution containing Na2EDTA . (5.0mM), CaCl2 (1.0mM), KCL (120mM), Na2HPO4 (50mM), pH 7.4.
WASH (NMR Fluidics System Solution) Triton X-100-0.1%v/v, Liqui Nox . 0.1% v/v in deionized water, pH 10.0.
NMR Reference Standard 0.2% w/v aqueous solution of Trimethyl Acetate . (TMA) disodium salt (15.0 mM) containing Na2EDTA (5.0 mM), CaCl2 (3.0 mM) KCl (120 nM), D2O 10% v/v.
NMR LipoProfile® test Quality Control material two levels of pooled human . serum-based control material, labeled Control A and Control B, with predetermined target ranges, containing 0.02% sodium azide as a preservative.
NMR Profiler 400 MHz proton nuclear magnetic resonance spectrometer . interfaced with a liquid sample handler, deconvolution software and provided with a system Operator's Manual.

F. Indications for Use

G. Technological Characteristics and Substantial Equivalence:

The NMR LipoProfile test, when used with the NMR Profiler is as safe and effective as the previously cleared NMR LipoProfile test and NMR Profiler. The NMR LipoProfile test has the same intended use and indication for use as well as the same principle of operation as the predicate device. The minor technological differences between the NMR LipoProfile test and the predicate device raise no new issues of safety or effectiveness. Performance data further demonstrate that the NMR LipoProfile test is as safe and effective as its predicate device. Thus, the NMR LipoProfile test, when used with the NMR Profiler is substantially equivalent to the predicate device.

Similarity to the Predicate Device

As with the predicate test, the NMR LipoProfile test is intended for the separation and quantification of LDL-P, HDL-C and triglycerides in serum and plasma, measurements

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of which are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

Therefore, substantial equivalence of the NMR LipoProtein test to the claimed predicate device is based upon the following:

1. Both devices have the same intended use and indications for use statements.
1. Both devices use the same clinical test specimen (human serum and plasma).
1. Both devices provide the same analytical test result.
1. Both devices have substantially similar safety and effectiveness when used as intended.
1. Both devices utilize the same signal generation and signal processing algorithm.
1. Both devices have the same reference range.

Differences from the Predicate Device

The NMR LipoProfile test differs from its predicate in two ways:

The Gen 2.1 software used with the NMR LipoProfile® test and NMR Profiler 1. is a modified version of the predicate software which enhances the curve fit of the software algorithm used for calculating LDL-P results.
1. The modular software architecture utilizes updated Assay Server software and is designed to allow interface with multiple Data Analysis Software that calculates individual analyte values. The modified architecture enables separate modules for analytes which allows for modules to change and new modules to be added with no impact to the signal generation or to other unmodified analytes.

Substantial Equivalence Summary

The proposed NMR LipoProfile® test and NMR Profiler is substantially equivalent to the predicate device. There are no significant differences which would affect safety and effectiveness of the proposed device.

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Performance Data - Non-Clinical: H.

Analytical Sensitivity

The analytical sensitivity of the NMR LipoProfile test measurements of LDL-P, HDL-C, and triglycerides was determined as the lowest concentration measurable with acceptable precision and accuracy. Serum specimens with low initial concentrations LDL-P, HDL-C, and triglycerides were serially diluted and 20 replicates of each were analyzed. CV s and % bias between observed and target values were determined and acceptance criteria are based on total error ≤20%. Limits of quantification (LOQ) are 300 nmol/L for LDL-P, 10 mg/dL for HDL-C, and 25 mg/dL for triglycerides.

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 20 different runs over 20 days. The pools were analyzed according to EP-5A. The results of this testing are summarized below:

Within-run Precision (n=20)

	Pool #1				Pool #2				Pool #3
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
LDL-P,nmol/L	908	45.4	5.0%	1493	64.8	4.3%	1967*	72.8	3.7%
HDL-C,mg/dL	23.7	0.5	2.0%	54.9*	1.0	1.9%	95.1	0.9	0.9%
Triglycerides,mg/dL	81.0	2.1	2.6%	140.6	2.5	1.8%	649.5	8.7	1.3%

*One replicate of the medium and high pool produced no data resulting in a n=19

Within-Laboratory Precision (n=80)

	Pool #1			Pool #2			Pool #3
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
LDL-P,nmol/L	920.4	70.5	7.7%	1508.3	67.7	4.5%	1991.8	84.6	4.3%
HDL-C,mg/dL	23.7	0.8	3.3%	56.7	1.1	2.0%	96.1	1.7	1.8%
Triglycerides,mg/dL	78.4	2.8	3.6%	145.4	3.7	2.6%	624.6	15.4	2.5%

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Linearity

Three serum pools were prepared from patient specimens with low, medium and high values of LDL-P, HDL-C and Triglycerides as determined by NMR LipoProfile test. Each were mixed and diluted in different proportions to produce eleven (for LDL-P) or Twelve (12) (TG and HDL-C) 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. Tables and regression plots of the linearity data for LDL-P, HDL-P and Triglycerides are given below:

Level	1	2	3	4	5	6	7	8	9
Targetvalue	184.0	247.7	874.2	1373.2	1875.9	2371.1	2870.1	3369.1	3868.0
ObservedMean	179.3	280.3	839.3	1309.8	1825.5	2309.3	2737.8	3309.3	3868.5
Non-linearity	35.4	30.3	-10.5	-29.7	-37.2	-32.9	-16.8	10.9	50.4
Nonlinearitygoal	52.1	52.1	87.4	137.3	187.6	237.1	287.0	336.9	386.8

LDL-P Measuring Range: 300-3500 nmol/L

Image /page/5/Figure/6 description: The image is a linearity plot showing the relationship between LDL-P (nmol/L) and Target LDL-P (nmol/L). The plot includes a linear fit with the equation y = 0.9843x - 11.994 and an R-squared value of 0.9974. Additionally, a polynomial fit is shown with the equation (39.48 +0.8929x +2.3585E-005x²). The x and y axis both range from 0 to 4000.

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Level	1	2	3	4	5	6	7	8	9	10	11	12
Targetvalue	6.3	9.4	10.9	28.0	43.4	59.0	74.4	89.8	105.3	120.8	170.3	204.4
ObservedMean	6.5	9.3	10.8	26.8	41.8	58.0	74.0	90.0	106.0	121.3	169.3	205.3
Nonlinearitygoal	0.7	0.9	1.1	2.8	4.3	5.9	7.40	9.0	10.5	12.1	17.0	20.4

HDL-C Measuring Range: 7-140 mg/dL

Image /page/6/Figure/4 description: The image is a linearity plot showing the relationship between target HDL-C and HDL-C. The x-axis represents the target HDL-C in mg/dL, and the y-axis represents the HDL-C in mg/dL. A linear fit line is plotted on the graph, and the equation of the line is y=1.004x-0.5956, with an R-squared value of 0.9998.

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Level	1	2	3	4	5	6	7	8	9	10	11
Targetvalue	5.4	10.9	21.8	43.6	79.5	133.4	223.2	492.7	941.8	1390.9	1840
Observedaverage	5	11.3	22.1	48.6	88	143.1	232	513.7	964.9	1414	1857
Nonlinearitygoal	2.6	2.6	2.6	4.3	8.0	13.5	22.7	50.2	96.2	142.1	188.0

Triglycerides Measuring Range: 5-1100 mg/dL

Image /page/7/Figure/4 description: The image is a linearity plot showing TG (mg/dL) on the y-axis and Target TG (mg/dL) on the x-axis. The plot includes two trendlines: a linear fit represented by the equation (2.057 + 1.006x) and a polynomial fit represented by the equation (0.4374 + 1.003x +3.5192E-005x² - 1.9654E-008x³). The data points appear to follow a linear relationship, as both trendlines closely overlap.

Linear Regression analysis: y=1.006x + 2.057 R2=0.9998

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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 NMR LipoProfile® test by LipoScience. Five endogenous agents and twenty two drugs were screened for potential interfering effects to NMR LipoProfile test using concentrations in accordance to CLSI EP7-A2 guidelines.

Endogenous		Exogenous (OTC drugs, etc.)
Potential Interferent	Test Concentration	Potential Interferent	Test Concentration
Hemoglobin	2 mg/mL	Simvastatin	48 µg/mL
Bilirubin, unconj.	200 µg/mL	Fenofibrate	45 µg/mL
Creatinine	50 µg/mL	Nicotinic Acid Sodium salt	1.2 mg/mL
Urea	2.6 mg/mL	Acetylsalicylic acid	652 µg/mL
Uric acid	235 µg/ml	Acetaminophen	200 µg/mL
		Naproxen Sodium	547 µg/mL
		Ibuprofen Sodium salt	2101, 702µg/mL
		Piroxicam	60 µg/mL
		Hydrochlorothiazide	6.0 µg/mL
		Triamterene	8.9 µg/mL
		Pravastatin	48 µg/mL
		Furosemide	60 µg/mL
		Metoprolol tartrate	6.4 µg/mL
		Nifedipine	400 µg/mL
		Enalaprilat Dihydrate	0.3 µg/mL
		Hydralazine hydrochloride	180 µg/mL
		Isosorbide dinitrate (lactosemixture 2:3)	375 µg/mL
		Clopidogrel hydrogensulfate	360 µg/mL
		Glipizide	2.0 µg/mL
		Metformin Hydrochloride	600 µg/mL
		Pioglitazone hydrochloride	27 µg/mL
		Atorvastatin	48 µg/mL

For LDL-P and HDL-C

2 Test results for triglycerides were ~4 to 6% lower at the 140 and 210 µg/mL concentrations of ibuprofen

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Method Comparison - Non-Clinical: H.

Method Comparison – LDL-P

Method comparison was evaluated by using serum samples across the reportable range of the NMR LipoProfile test for LDL-P on the NMR Profiler. LDL-P concentrations ranged from 315to 3497 nmol/L.

Image /page/9/Figure/5 description: This image is a scatter plot with a linear fit. The x-axis is labeled LP2 LDL-P, and the y-axis is labeled LP3.1 LDL-P. The plot shows a strong positive correlation between the two variables, with most of the data points clustered around the linear fit line. The equation for the linear fit is y=0.98x+46.42, and the correlation coefficient is r=0.970.

LDL-P (GEN2.1) vs. LDL-P (Predicate) Linear Regression (n=1555)

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Method Comparison – HDL-C

Method comparison was evaluated by using serum samples across the reportable range of the NMR LipoProfile test for HDL-C on the NMR Profiler. HDL-C concentrations ranged from 12 to 140 mg/dL.

Image /page/10/Figure/4 description: This image is a scatter plot that shows the linear regression of HDL-C (GEN2.1) vs. HDL-C (LP2 Predicate) with n=1599. The x-axis represents HDL-C (LP2 Predicate) values ranging from 0 to 150, while the y-axis represents HDL-C (GEN2.1) values ranging from 0 to 160. The plot includes an identity line, a linear fit line represented by the equation (0.03 + 1.00x), and 95% confidence interval bands.

Linear regression analysis: y = 1.00x +0.03 r = 0.999

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Method comparison Triglycerides

Method comparison was evaluated by using serum samples across the reportable range of the NMR LipoProfile test for Triglycerides on the NMR Profiler. Triglyceride concentrations ranged from 20 to 925 mg/dL.

Image /page/11/Figure/4 description: The image is a scatter plot with a linear fit, titled "TG (GEN2.1) vs. TG (LP2 Predicate) Linear Regression Chart (n=1597)". The x-axis is labeled "TG (LP2)" and the y-axis is labeled "TG". The plot shows a strong positive correlation between the two variables, with the data points clustered closely around the linear fit line. The linear fit equation is shown as (1.17 + 1.00x), and there is a legend indicating the identity and 95% CI bands.

Linear regression analysis: y = 1.00x +1.17 r = 1.00

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K. Standard/Guidance Document Referenced (if applicable):

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

CLSI EPS-A2. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.

CLSI EP9-A2. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.

CLSI EP17-A. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.

CLSI EP6-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

CLSI C28-A3. Defining Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline

This device has not been tested by the Cholesterol Reference Method Laboratory Network.

M. Clinical Studies:

Clinical Sensitivity: છે.
Not Applicable
b. Clinical specificity:
Not Applicable
Other clinical supportive data (when a. and b. are not applicable): C.
Not Applicable
1. Clinical cut-off:
  Not Applicable

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2. Expected values/Reference range:

Distribution of LDL-P Observed in a Reference Population – Multi-Ethnic Study of Atherosclerosis (MESA)

	All(n=5,362)	Men(n=2,529)	Women(n=2,833)
Percentile	LDL-P(nmol/L)	LDL-P(nmol/L)	LDL-P(nmol/L)
5	770	800	760
10	870	900	850
20	1000	1040	970
30	1100	1150	1060
40	1190	1250	1150
50	1280	1330	1230
60	1380	1430	1330
70	1480	1530	1440
80	1610	1640	1570
90	1790	1820	1760
95	1980	1990	1970

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Image /page/14/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized bird symbol in the center. The text around the perimeter reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The bird symbol is composed of three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

LipoScience, Inc. c/o Suzette Warner Regulatory Affairs Manager 2500 Sumner Boulevard Raleigh. NC 27616

Re: K111516

SEP 27 201

Trade/Device Name: NMR LipoProfile Test and NMR Profiler Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, subject to limitation of exemption in 21 CFR 862.9(c)(4) Product Code: MRR, LBS, CDT Dated: August 11, 2011 Received: August 15, 2011

Dear Ms. 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 10 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. 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.

ff your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number:

k111516_______________________________________________________________________________________________________________________________________________________________________

Device Name:

NMR LipoProfile® test and NMR Profiler

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Qutl C. Anlen

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

Page 1 of 1_

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.