Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard NMR spectroscopy and data analysis techniques, with no mention of AI or ML algorithms for spectral deconvolution or analyte quantification.

Therapeutic

No.
This device is an automated laboratory test analyzer used to quantify analytes in clinical samples, which aids in diagnosis and management of conditions, rather than directly treating them.

Diagnostic

Yes

The device measures analyte concentrations to aid in the management of lipoprotein disorders associated with cardiovascular disease, which directly contributes to the diagnosis or management of a disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Vantera Clinical Analyzer includes hardware components such as a sample handling assembly, an NMR subassembly, and an enclosure, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device "measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration." It also mentions being used with "NMR based assays to detect multiple analytes from clinical samples." This clearly indicates the device is used to perform tests on biological samples (clinical samples) to obtain diagnostic information (analyte concentration).
Specific Test: The description of the NMR LipoProfile test further reinforces this by stating it "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." These measurements are then used "in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease." This is a classic example of an in vitro diagnostic test.
Device Description: The device is described as a "clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum." This aligns with the definition of an IVD device used in a clinical laboratory setting.
Clinical Samples: The device is designed to analyze "clinical samples," specifically "blood plasma and serum," which are biological specimens taken from the human body.
Analyte Measurement: The core function is to measure "analyte concentration," which is a key characteristic of IVD devices.

The information provided strongly supports the classification of the Vantera Clinical Analyzer and the NMR LipoProfile test as In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the Instrument
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 by technologists trained in laboratory techniques, procedures and on the use of the analyzer.

For the Assay
The NMR LipoProfiletest, 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.

Product codes (comma separated list FDA assigned to the subject device)

NSU, MRR, LBS, CDT

Device Description

For the Instrument
The Vantera Clinical Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum.

The Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure. The Vantera Clinical Analyzer control system is distributed across three separate computers:

. The Host (1U) controls user interface, data handling, results calculation, system startup and shutdown.
. The Process Control (4U) schedules and manages all activities required to process a sample, controls all hardware in the sample handling subsystem, and manages remote access to the system.
. The NMR Control Computer controls all magnet operations.

Two of these computers are contained within the Sample Handling Subassembly (1U and 4U) and one in the NMR Subassembly (NMR Console).

For the Assay
The NMR LipoProfile test 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Nuclear magnetic resonance (NMR) spectrum

Anatomical Site

Not Found

Indicated Patient Age Range

ranging from 18 to 84 years

Intended User / Care Setting

technologists trained in laboratory techniques, procedures and on the use of the analyzer.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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. Limits of quantification (LoQ), Limit of Blank (LoB) and Limit of Detection (LoD) for LDL-P, HDL-C and Triglycerides following EP17-A are listed

LDL-P

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for LDL-P by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoO = 132 nmol/L.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for LDL-P and determined to be: LoB = 0.0 nmol/L.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for LDL-P and determined to be: LoD = 40.7 nmol/L.

HDL-C

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for HDL-C by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoO = 4 mg/dL.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for HDL-C and determined to be: LoB = 2.7 mg/dL.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for HDL-C and determined to be: LoD = 3.5 mg/dL.

Triglycerides

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for Triglycerides by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoQ = 4 mg/dL.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for Triglycerides and determined to be: LoB = 1.1 mg/dL.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for Triglycerides and determined to be: LoD = 2.4 mg/dL.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Limits of quantification (LoQ), Limit of Blank (LoB) and Limit of Detection (LoD) for LDL-P, HDL-C and Triglycerides following EP17-A are listed

LDL-P

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for LDL-P by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoO = 132 nmol/L.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for LDL-P and determined to be: LoB = 0.0 nmol/L.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for LDL-P and determined to be: LoD = 40.7 nmol/L.

HDL-C

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for HDL-C by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoO = 4 mg/dL.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for HDL-C and determined to be: LoB = 2.7 mg/dL.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for HDL-C and determined to be: LoD = 3.5 mg/dL.

Triglycerides

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Quantification (LoQ) was mathematically calculated for Triglycerides by plotting the %CV on the Y-axis against low concentration pools and determined to be: LoQ = 4 mg/dL.

Non-lipoprotein specimens were analyzed 60 consecutive times for 3 days. The Limit of Blank (LoB) was calculated non-parametrically for Triglycerides and determined to be: LoB = 1.1 mg/dL.

Five serum pools containing very low concentration were tested in replicates of 4 for 3 days. The Limit of Detection (LoD) was calculated parametrically for Triglycerides and determined to be: LoD = 2.4 mg/dL.

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	842.6	48.5	5.8	1309.5	39.1	3.0	1837.7	50.3	2.7
HDL-C, mg/dL	29.1	1.17	4.0	51.1	1.43	2.8	86.9	2.29	2.6
Triglycerides, mg/dL	70.1	1.6	2.3	169.2	3.5	2.1	356.1	4.2	1.2

Within-Laboratory Precision (n=80)

	Pool #1			Pool #2			Pool #3
	Mean	SD	%CV	Mean	SD	%CV	Mean	SD	%CV
LDL-P, nmol/L	988.6	52.20	5.3	1266.7	50.08	4.0	1943.5	75.11	3.9
HDL-C, mg/dL	28.9	0.80	2.8	50.7	1.02	2.0	85.2	1.51	1.8
Triglycerides, mg/dL	68.8	1.59	2.3	166.3	3.92	2.4	352.2	9.36	2.7

Reproducibility

A reproducibility study was conducted in accordance to EPS-A2 at 3 sites 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.

	LDL-P (nmol/L)
Pool #	1	11	7	3	9
NMR 8001	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (nmol/L)	513.4	1129.4	1361.6	1957.7	3286.5
n	60	60	60	59	60
SD (nmol/L)	32.86	65.60	87.36	103.55	197.94
CV (%)	6.4	5.8	6.4	5.3	6.0
min (nmol/L)	431	988	1163	1641	2938
max (nmol/L)	573	1318	1510	2179	3636
median (nmol/L)	517	1127	1380.5	1962	3288.5
NMR 8002	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (nmol/L)	566.7	1260.6	1364.5	2050.7	3204.7
n	59	60	59	59	60
SD (nmol/L)	39.22	38.00	76.99	65.41	85.41
CV (%)	6.9	3.0	5.6	3.2	2.7
min (nmol/L)	457	1168	1155	1843	3036
max (nmol/L)	660	1346	1555	2176	3419
median (nmol/L)	574	1258.5	1366	2050	3197
NMR 8003	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (nmol/L)	479.8	1156.3	1304.4	1980.6	3153.3
n	58	60	60	60	60
SD (nmol/L)	45.00	70.60	113.21	91.78	165.47
CV (%)	9.4	6.1	8.7	4.6	5.2
min (nmol/L)	388	871	891	1671	2561
max (nmol/L)	558	1255	1491	2136	3386
median (nmol/L)	485.5	1167	1337	1999	3192
All	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (nmol/L)	520.2	1182.1	1343.4	1996.2	3214.8
n	177	180	179	178	180
SD (nmol/L)	52.94	82.19	97.37	96.39	165.44
95% CI (nmol/L)	47.94-59.11	74.48-91.68	88.22-108.66	87.31-107.59	149.93-184.55
CV (%)	10.2	7.0	7.2	4.8	5.1
min (nmol/L)	388	871	891	1641	2561
max (nmol/L)	660	1346	1555	2179	3636
median (nmol/L)	491	1165	1330	2006	3179

	HDL-C (mg/dL)					TG (mg/dL)
Pool #	1	8	4	10	11	2	4	3	6	9
NMR 8001	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (mg/dL)	21.5	33.4	53.7	80.1	92.1	66.1	70.3	133.5	153.5	343.3
n	60	60	60	60	60	60	60	59	60	60
SD (mg/dL)	0.75	1.39	1.81	3.70	2.61	1.84	2.15	4.35	5.92	7.09
CV (%)	3.5	4.2	3.4	4.6	2.8	2.8	3.1	3.3	3.9	2.1
min (mg/dL)	20	30	49	74	87	61	64	120	129	321
max (mg/dL)	23	36	57	88	97	69	73	141	163	356
median (mg/dL)	21.5	34	54	78.5	92	66	71	134	155	345
NMR 8002	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (mg/dL)	19.4	29.2	52.3	72.9	87.5	70.3	74.6	141.4	169.7	361.1
n	59	60	60	60	60	59	60	59	60	60
SD (mg/dL)	0.68	1.13	1.34	1.49	1.28	1.30	1.59	3.03	3.10	5.01
CV (%)	3.5	3.9	2.6	2.0	1.5	1.8	2.1	2.1	1.8	1.4
min (mg/dL)	17	27	48	70	85	68	72	131	160	341
max (mg/dL)	21	31	56	76	90	74	82	149	176	372
median (mg/dL)	19	29	52	73	88	70	74	142	170	361
NMR 8003	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5
Mean (mg/dL)	19.4	28.3	49.9	74.4	84.9	66.5	70.4	134.3	160.9	339.8
n	58	60	60	60	60	60	60	60	60	60
SD (mg/dL)	0.90	1.41	2.36	4.26	3.39	2.70	3.44	4.77	7.10	18.50
CV (%)	4.6	5.0	4.7	5.7	4.0	4.1	4.9	3.5	4.4	5.4
min (mg/dL)	17	24	41	66	72	57	58	119	123	267
max (mg/dL)	21	31	53	83	89	71	74	145	169	357
median (mg/dL)	19	28	50	73	86	67	72	135	162	346
All	Panel 1	Panel 2	Panel 3	Panel 4	Panel 5	All	Panel 1	Panel 2	Panel 3	Panel 4
Mean (mg/dL)	20.1	30.3	52.0	75.8	88.2	67.6	71.8	136.4	161.4	348.0
n	177	180	180	180	180	179	180	178	180	180
SD (mg/dL)	1.26	2.60	2.45	4.56	3.91	2.76	3.21	5.41	8.66	14.99
95% CI (mg/dL)	1.14-1.41	2.35-2.90	2.22-2.73	4.14-5.09	3.55-4.36	2.50-3.08	2.91-3.59	4.90-6.03	7.75-9.66	13.59-16.72
CV (%)	6.3	8.6	4.7	6.0	4.4	4.1	4.5	4.0	5.4	4.3
min (mg/dL)	17	24	41	66	72	57	58	119	123	267
max (mg/dL)	23	36	57	88	97	74	82	149	176	372
median (mg/dL)	19	28	50	73	86	67	71	135	162	344

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	10	11
Target value	225.4	263.375	673.75	1039.25	1222	1473.28	1770.25	2291.41	2968.22	3645.03	4321.84
Observed Mean	248.8	243.8	682.0	1115.0	1285.8	1402.3	1829.8	2437.5	3032.3	3644.3	4442.8
% Bias	10.3	-7.5	1.2	7.3	5.2	-4.8	3.4	6.4	2.2	0.0	2.8

Y=1.0193x + 7.8226, R2 = 0.9949

Level	1	2	3	4	5	6	7	8	9
Target value	6.13	21.44	28.19	35.56	42.94	50.31	72.75	110.25	147.75
Observed Mean	5.00	22.50	29.25	36.25	43.25	50.75	81.50	117.25	151.50
% Bias	-	5.0	3.8	1.9	0.7	0.9	12.0	6.3	2.5

Y=1.0486x - 0.3459, R2 = 0.9961

Level	1	2	3	4	5	6	7	8	9	10	11	12	13
Target value	3.8	5.1	9.2	29.0	82.5	134.6	178.1	221.5	308.4	531.0	802.6	1074.2	1345.7
Observed average	5.5	6.8	11.0	26.3	84.5	135.0	177.8	219.3	306.0	536.0	816.8	1079.0	1356.3
% Bias	43.1	31.7	19.2	-9.5	2.4	0.3	-0.2	-1.0	-0.8	0.9	1.8	0.5	0.8

= 0.9999 Y=1.008x-0.3979, F

Reportable Range

The following are the reportable ranges for LDL-P, HDL-C and Triglycerides:

LDL-P	300 - 3500 nmol/L
HDL-C	7 - 140 mg/dL
Triglycerides	5-1100 mg/dL

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. Seven endogenous agents and twenty three 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	0.5 g/dL	Acetaminophen	1324 µmol/L
Bilirubin, unconj.	342 µmol/L 20 mg/dL	Acetylsalicylic acid	3.62 mmol/L
Creatinine	442 µmol/L 5 mg/dL	Atorvastatin	600 µg Eq/L
Urea	42.9 mmol/L	Clopidogrel hydrogensulfate**	95.7 µmol/L
	260 mg/dL	Enalaprilat Dihydrate	0.86 µmol/L
Uric acid	1.4 mmol/L 23.5 mg/dL	Fenofibrate	125 µmol/L
Protein (albumin)	6 g/dL	Furosemide	181 µmol/L
	60g/L	Glipizide	4.48 µmol/L
Bilirubin, conj	342 µmol/L 28.9 mg/dL	Hydralazine hydrochloride	915.4 µmol/L
		Heparin	3000U/L
		Ibuprofen Sodium salt	2425 µmol/L
		Isosorbide dinitrate	636 nmol/L
		Menhaden oil (Fish Oil)	2.4 mg/mL
		*Salicyclic acid at ≥ 1.3mmol/L was determined to interfere with LDL-P
		**Clopidogrel hydrogensulfate at ≥ 95.7 µmol/L was determined to interfere with LDL-P
		Potential Interferent	Test Concentration
		Metformin Hydrochloride	3.62 mmol/L
		Metoprolol tartrate	18.7 µmol/L
		Naproxen Sodium	2170 µmol/L
		Nicotinic Acid Sodium salt	8.28 mmol/L
		Nifedipine	1156 nmol/L
		Pioglitazone hydrochloride	152.7µmol/L
		Piroxicam	181 µmol/L
		Pravastatin	107.5 µmol/L
		Salicylic Acid*	1.3 mmol/L
		Simvastatin	114.7 µmol/L

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 Vantera Clinical Analyzer. LDL-P concentrations ranged from 303.0 to 3505.0nmol/L.

Y=1.03x - 36.60 r=0.978

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 Vantera Clinical Analyzer. HDL-C concentrations ranged from 7.0 to 132 mg/dL.

Y=1.04x-1.20, and the correlation coefficient is r=0.989.

Method comparison Triglycerides

Method comparison was evaluated by using serum samples across the reportable range of the NMR LipoProfile test for Triglycerides on the Vantera Clinical Analyzer. Triglyceride concentrations ranged from 18.0 to 1095.0 mg/dL.

Y=1.00x + 0.92 r=0.998

M. Clinical Studies:
Clinical Sensitivity: a.
Not Applicable

Clinical specificity: b.
Not Applicable

Other clinical supportive data (when a. and b. are not applicable): c.
: .
Not Applicable

l. Clinical cut-off:
Not Applicable

Expected values/Reference range:
In order to determine the distribution of LDL-P levels expected in a representative sampling of the general population, serum samples (n=452) were analyzed from apparently healthy men (n=158) and women (n=294) (ranging from 18 to 84 years). The following table provides the concentrations of LDL-P by percentile in this reference population:

	All (n=452)	Men (n=158)	Women (n=294)	All (n=452)	Men (n=158)	Women (n=294)
Percentile	LDL-P (nmol/L)	LDL-P (nmol/L)	LDL-P (nmol/L)	LDL-C (mg/dL)	LDL-C (mg/dL)	LDL-C (mg/dL)
5	539	528	542	63	62	65
10	643	713	638	75	76	75
20	784	883	749	84	90	83
30	909	1004	863	94	100	91
40	1009	1087	970	102	107	98
50	1127	1241	1070	109	113	109
60	1248	1366	1202	118	128	115
70	1396	1505	1322	129	137	124
80	1572	1676	1482	140	147	136
90	1894	1941	1818	157	161	151
95	2047	2169	1986	169	171	169

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111516, K073506

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine 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.

Summary

0

510(k) Summary

LIPOSCIENCE
A.
KIL3830 510(k) Number:
AUG
30
2012

B. Submitter Contact Information:

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:

Vantera® Clinical Analyzer Trade Name: NMR LipoProfile® test on Vantera® Clinical Analyzer Common Name: Classification Names:

Instrumentation for clinical multiplex test system, 21 CFR 862.2570, Product Code NSU 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

Clinical Chemistry (75) Panel:

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

NMR Profiler and NMR Lipoprofile test	K111516
Luminex LX 100/200 Instrument	K073506

1

E. Device Description:

For the Instrument

The Vantera Clinical Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically blood plasma and serum.

The Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure. The Vantera Clinical Analyzer control system is distributed across three separate computers:

. The Host (1U) controls user interface, data handling, results calculation, system startup and shutdown.
. The Process Control (4U) schedules and manages all activities required to process a sample, controls all hardware in the sample handling subsystem, and manages remote access to the system.
. The NMR Control Computer controls all magnet operations.

Two of these computers are contained within the Sample Handling Subassembly (1U and 4U) and one in the NMR Subassembly (NMR Console).

For the Assay

The NMR LipoProfile test 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.

F. Indications for Use

For the Instrument

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

2

spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples by technologists trained in laboratory techniques, procedures and on the use of the analyzer.

For the Assay

The NMR LipoProfiletest, 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.

G. Technological Characteristics and Substantial Equivalence:

The Vantera Clinical Analyzer is as safe and effective as the predicate device, K073506. The Vantera has similar intended use and indication for use as well as the same multianalyte capability and the same system calibration requirement as the predicate device. The minor technological differences between the Vantera and the predicate device raise no new issues of safety or effectiveness.

3

	Instrument Comparison Table
--	-----------------------------	--

| | Luminex LX 100/200
Instrument
(Predicate) | Vantera Clinical Analyzer
(Proposed Device) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K073506 | Pending |
| Intended Use /
Indications for
Use | The Luminex LX
100/200 Instrument is a
clinical multiplex test
system intended to
measure and sort multiple
signals generated in an In
Vitro diagnostic assay
from a clinical sample.
This instrumentation is
used with a specific assay
to measure multiple
similar analytes that
establish a single
indicator to aid in
diagnosis. The device
includes a signal reader
unit, raw data storage
mechanisms, data
acquisition software and
software to process
detected signals. | similar |
| Technology | Bead based multiplexing | Nuclear magnetic
resonance |
| Multi-Analyte | Yes | same |
| Detection
Method | Fluorescent | 400 MHz proton NMR
Spectrum |
| System
Fluidics | Utilizes system fluidics to
deliver sample to the site
of sample analysis | same |
| Specimen
Sampling and
Handling | Samples are manually
prepared then presented to
system. | Serum/Plasma Samples are
diluted onboard system |
| System
Calibration | System calibration
required | same |
| | Luminex LX 100/200
Instrument
(Predicate) | Vantera Clinical Analyzer
(Proposed Device) |
| Quality
Control
Checks | System level quality
control checks available
e.g. Classification (CONI)
and reporter (CONII) | similar
E.g. Signal to noise ratio –
internal system check that
occur during system
calibration |
| Specimen
Identification | Barcode reader entry of
sample ID | same |
| Data
Acquisition
Software | Posses data acquisition
software and software to
process detected signals | same |

·

...

4

Similarity to the Predicate Device (Assay)

Performance data further demonstrate that the Vantera Clinical Analyzer when used with the NMR LipoProfile test is as safe and effective as its predicate device, K111516. As with the predicate test, the NMR LipoProfile test on Vantera is intended for the separation and quantification of LDL-P, HDL-C and triglycerides in serum and plasma, measurements 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.

5

| | LipoScience
NMR LipoProfile® test
and NMR Profiler
(Predicate) | Vantera® Clinical
Analyzer for use with
NMR LipoProfile® test
(Proposed Device) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K111516 | Pending |
| Intended Use /
Indications for
Use | The NMR LipoProfile®
test, used with the NMR
Profiler, an automated
nuclear magnetic
resonance (NMR)
spectrometer, measures
lipoprotein particles to
quantify LDL particle
number (LDL-P), HDL
cholesterol (HDL-C), and
triglycerides in serum
and plasma using NMR
spectroscopy. LDL-P
and these NMR-derived
concentrations of
triglycerides and HDL-C
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. | similar |
| Patient
Population | General | same |
| Instrument
Platform | NMR Profiler | Vantera Clinical Analyzer |
| Specimen
Analyzer | Human serum and plasma | same |
| | 400 MHz NMR
Spectrometer | same |
| | LipoScience
NMR LipoProfile® test
and NMR Profiler
(Predicate) | Vantera® Clinical
Analyzer for use with
NMR LipoProfile® test
(Proposed Device) |
| Reagents and
Materials | NMR Diluent 1 - aqueous solution containing Na2EDTA (5.0mM), CaCl2 (1.0mM), KCL(120mM), Na2HPO4-7H20(50mM), (50mM), pH 7.4, 6.0 M NaOH, 1.0 M HCl. NMR WASH - Triton X-100-0.1%v/v, Liqui Nox 0.1% v/v in Type 2 water, pH 10.0, sodium bicarbonate (anhydrous), sodium carbonate (anhydrous), 6.0 M NaOH NMR Calibrator - aqueous solution of Trimethyl Acetate (TMA) disodium salt (15.0 mM) containing Na2EDTA (5.0 mM), CaC2 (3.0 mM), KCl (120 nM), D2O 10% v/v NMR LipoProfile Quality Control materials 1 and 2 contains two levels of pooled human serum-based control material, labeled Control 1 and Control 2, with pre-determined target ranges, containing sodium azide as a preservative. | Similar |
| | LipoScience
NMR LipoProfile® test
and NMR Profiler
(Predicate) | Vantera® Clinical
Analyzer for use with
NMR LipoProfile® test
(Proposed Device) |
| Spectral
Deconvolution
Computational
Process | Linear least-squares
with singular value
decomposition of the
spectra from each
specimen. | Same |
| Reference
Range | Distribution of LDL-P
Observed in Reference
population - MESA | Distribution of LDL-P
observed in a general
apparently healthy
population of men and
women |

Assay General Attributes

.

6

7

We performed analytical validations to demonstrate that the NMR LipoProfile® test on the Vantera Clinical Analyzer is equivalent to the NMR LipoProfile® test on the NMR Profiler. The comparative analytical performance is found in tables below.

·

8

Vantera® Clinical Analyzer for use with NMR LipoProfile® test Premarket Notification 510(k) Section 6 -- 510(k) Summary

| LDL-P (nmol/L) for use with the
NMR LipoProfile test |-------------------------|--- | LoB | 0 | LoD | 40.7 | LoQ | 132 | Measuring Range | Linearity Regression | Linearity R² | 0.9949 | Within-Run Precision | Level 1 | Mean | 842.6 | SD | 48.5 | CV% | 5.8% | Within-Lab Precision | Level 1 | Mean | 988.6 | SD | 48.84 | CV% | 5.3% | Method Comparison y=1.03x-36.60, R=0.978 y=0.98x+45.2, R=0.973 | Medical Decision Limits | No change. | Interference Study tested. Salicyclic acid was determined to interfere P and Clopidogrel hydrogensulfate ≥ 95.7 µmol/L was determined to
interfere with LDL-P were tested, no interference was
found. | | | | Specimen Stability Refrigerated Stability: 6 days Refrigerated Stability: 5 days | Vantera clinical analyzer
| Predicate Device K111516 | | | | |
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------|---------|---------|---------|
| 0 | | | | |
| 41 | | | | |
| 157 | | | | |
| 300-3500 nmol/L | 300-3500 nmol/L | | | | |
| y=1.02x+7.82 | y=0.99x-22.37 | | | | |
| 0.9979 | | | | |
| Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| 1309.5 | 1837.7 | 908 | 1493 | 1967 |
| 39.1 | 50.3 | 45.4 | 64.8 | 72.8 |
| 3.0% | 2.7% | 5.0% | 4.3% | 3.7% |
| Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| 1266.7 | 1943.5 | 920.4 | 1508.3 | 1991.8 |
| 32.57 | 63.42 | 70.5 | 67.7 | 84.6 |
| 4.0% | 3.9% | 7.6% | 4.5% | 4.3% |
| Linear regression:
| Linearity Regression:
| | | | |
| 1000, 1300 and 1600 nmol/L | | | | |
| 7 Endogenous and 23 Exogenous were
at ≥ 1.3mmol/L
with LDL-
at
| 5 Endogenous and 22 Exogenous
| |
| Lipotube:
| Lipotube:
| | | | |

Analytical Performance for LDL-P

.

9

Triglycerides Analytical Performance Summary
	Vantera clinical analyzer
for use with the
NMR LipoProfile test		Predicate Device K111516
TG (mg/dL)	LoB	1.1	1.4
	LoD	2.4	2.6
	LoQ	4	2.6
	Measuring Range	5	1100
	Linearity Regression	y=1.008x-0.3979	y=0.95x-12.21
	Linearity R2	0.9999	0.999
Within-Run Precision	Level 1	Level 2	Level 3	Level 1	Level 2	Level 3
Mean	70.1	169.2	356.1	81.0	140.6	649.5
SD	1.6	3.5	4.2	2.1	2.5	8.7
CV%	2.3%	2.1%	1.2%	2.6%	1.8%	1.3%
Within-Lab Precision	Level 1	Level 2	Level 3	Level 1	Level 2	Level 3
Mean	68.8	166.3	352.2	78.4	145.4	624.6
SD	1.59	3.92	9.36	2.8	3.7	15.4
CV%	2.3%	2.4%	2.7%	3.6%	2.6%	2.5%
Method Comparison	Linear regression:
y=1.00x+0.92, R=0.998			Linear regression:
y=1.00x+1.25, R=1.00
Medical Decision Limits	No change.			Normal ( Trade Name: Vantera® Clinical Analyzer; NMR LipoProfile® test on Vantera Clinical Analyzer Regulation Number: 21 CFR §862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: Class II Product Codes: NSU, MRR, LBS, CDT Dated: July 27, 2012 Received: July 30, 2012

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 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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).

29

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

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

Enclosure

30

Indication for Use

510(k) Number (if known):

KII 3830

Device Name:

Vantera® Clinical Analyzer

Indications for Use:

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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Ruta Clm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113830

Page 1 of 2

31

Indication for Use

k 113830

510(k) Number (if known):

Device Name:

NMR LipoProfile® test on Vantera® Clinical Analyzer

Indications for Use:

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 NMRplasma asing nacroal maginal can and triglycerides are used in conjunction with other livid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease.

Prescription Use X : (21 CFR Part 801 Subpart D) And/Or .

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Rute Chole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113830