Who is the manufacturer of VANTERA CLINICAL ANALYZER?

Liposcience filed the 510(k) submission for VANTERA CLINICAL ANALYZER (K113830).

What is the FDA product code for VANTERA CLINICAL ANALYZER?

CDT. It is classified under 21 CFR 862.1705 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for VANTERA CLINICAL ANALYZER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VANTERA CLINICAL ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VANTERA CLINICAL ANALYZER

Q: What are the predicate devices for VANTERA CLINICAL ANALYZER?

NMR Profiler and NMR Lipoprofile test (k111516); Luminex LX 100/200 Instrument (k073506).

K113830 · Liposcience · CDT · Aug 30, 2012 · Clinical Chemistry

Device Facts

Record ID	K113830
Device Name	VANTERA CLINICAL ANALYZER
Applicant	Liposcience
Product Code	CDT · Clinical Chemistry
Decision Date	Aug 30, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1705
Device Class	Class 1

Intended 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. 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 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.

Device Story

Vantera Clinical Analyzer is an automated 400 MHz proton NMR spectrometer; processes human serum/plasma samples. System includes sample handling assembly, NMR subassembly, and enclosure. Input: clinical samples; system performs automated dilution and spectral measurement. Operation: NMR spectrum deconvolution at ~0.8 ppm (methyl group protons) to produce signal amplitudes for lipoprotein subclasses; conversion to analyte concentrations. Output: LDL-P, HDL-C, and triglyceride levels. Used in clinical laboratories; operated by lab personnel. Results used by clinicians alongside other lipid measurements for cardiovascular disease management. Benefits: provides lipoprotein particle quantification to aid in managing lipid disorders.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2; linearity per EP6-A; interference per EP7-A2. Method comparison study (n=1482-1520 samples) against predicate NMR Profiler showed high correlation (r=0.978-0.998) and low bias (<5%) across medical decision limits. Matrix comparison (n=50) confirmed performance across LipoTube, plain serum, and EDTA plasma. Reference range study (n=452) established LDL-P distributions in healthy adults.

Technological Characteristics

400 MHz proton NMR spectrometer; automated sample handling with onboard dilution. Materials: glass/plastic sample containers, aqueous NMR diluent, TMA calibrator. Connectivity: networked control system (Host, Process Control, NMR Control computers). Software: spectral deconvolution algorithm. Sterilization: N/A (clinical analyzer).

Indications for Use

Indicated for use by trained laboratory technologists to measure lipoprotein particles (LDL-P, HDL-C, triglycerides) in human serum and plasma to aid in the management of lipoprotein disorders associated with cardiovascular disease. No specific age or gender contraindications noted.

Regulatory Classification

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.

Predicate Devices

NMR Profiler and NMR Lipoprofile test (k111516)
Luminex LX 100/200 Instrument (k073506)

Related Devices

K133849 — VANTERA CLINICAL ANALYZER · Liposcience · Oct 22, 2014
K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER · Liposcience, Inc. · Sep 27, 2011
K210801 — AXINON® LDL-p Test System · Numares AG · Jul 19, 2023

Submission Summary (Full Text)

{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) | Vantera clinical analyzer for use with the NMR LipoProfile test | Predicate Device k111516 | | | | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------|---------|---------|---------| | LoB | 0 | 0 | | | | | | LoD | 40.7 | 41 | | | | | | LoQ | 132 | 157 | | | | | | Measuring Range | 300-3500 nmol/L | 300-3500 nmol/L | | | | | | Linearity Regression | y=1.02x+7.82 | y=0.99x-22.37 | | | | | | Linearity R² | 0.9949 | 0.9979 | | | | | | Within-Run Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | | Mean | 842.6 | 1309.5 | 1837.7 | 908 | 1493 | 1967 | | SD | 48.5 | 39.1 | 50.3 | 45.4 | 64.8 | 72.8 | | CV% | 5.8% | 3.0% | 2.7% | 5.0% | 4.3% | 3.7% | | Within-Lab Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | | Mean | 988.6 | 1266.7 | 1943.5 | 920.4 | 1508.3 | 1991.8 | | SD | 48.84 | 32.57 | 63.42 | 70.5 | 67.7 | 84.6 | | CV% | 5.3% | 4.0% | 3.9% | 7.6% | 4.5% | 4.3% | | Method Comparison | Linear regression: y=1.03x-36.60, R=0.978 | Linearity Regression: y=0.98x+45.2, R=0.973 | | | | | | Medical Decision Limits | No change. | 1000, 1300 and 1600 nmol/L | | | | | | Interference Study | 7 Endogenous and 23 Exogenous were tested. Salicyclic acid at ≥ 1.3mmol/L was determined to interfere with LDL- P and Clopidogrel hydrogensulfate at ≥ 95.7 µmol/L was determined to interfere with LDL-P | 5 Endogenous and 22 Exogenous were tested, no interference was found. | | | | | | Specimen Stability | Lipotube: Refrigerated Stability: 6 days | Lipotube: Refrigerated Stability: 5 days | | | | | # 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 (<150) Borderline-High (150-199) High (200-499) Very High (≥500) | | | | Interference Study | 7 Endogenous and 23 Exogenous were tested, no interference was found. | | | 5 Endogenous and 22 Exogenous were tested, no interference was found except Ibuprofen may interfere with TG measurement at and above 210µg/mL. | | | | Specimen Stability | Lipotube: Refrigerated Stability: 6 days | | | Lipotube: Refrigerated Stability: 10 days | | | # Triglycerides Analytical Performance Summary {10}------------------------------------------------ | HDL-C (mg/dL) | | Vantera clinical analyzer for use with the NMR LipoProfile test | Predicate Device k111516 | | | | |-------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------|---------|---------| | LoB | | 2.7 | 4.3 | | | | | LoD | | 3.5 | 5.2 | | | | | LoQ | | 4 | 5.2 | | | | | Measuring Range | | 7-140 | 7-140 | | | | | Linearity Regression | | y=1.049x-0.3459 | y=1.004x-0.5956 | | | | | Linearity R2 | | 0.9961 | 0.9998 | | | | | Within-Run Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | | Mean | 29.1 | 51.1 | 86.9 | 23.7 | 54.9 | 95.1 | | SD | 1.17 | 1.43 | 2.29 | 0.5 | 1.0 | 0.9 | | CV% | 4.0% | 2.8% | 2.6% | 2.0% | 1.9% | 0.9% | | Within-Lab Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | | Mean | 28.9 | 50.7 | 85.2 | 23.7 | 56.7 | 96.1 | | SD | 0.80 | 1.02 | 1.51 | 0.8 | 1.1 | 1.7 | | CV% | 2.8% | 2.0% | 1.8% | 3.3% | 2.0% | 1.8% | | Method Comparison | Linear regression: y=1.04x-1.20, R=0.989 | | | Linear regression: y=1.00x+0.03, R=0.999 | | | | Medical Decision Limits | No change. | | | Low(<40), High(≥60) | | | | Interference Study | 7 Endogenous and 23 Exogenous were tested, no interference was found. | | | 5 Endogenous and 22 Exogenous were tested, no interference was found. | | | | Specimen Stability | Lipotube: Refrigerated Stability: 6 days | | | Lipotube: Refrigerated Stability: 10 days | | | HDL-C Analytical Performance Summary . {11}------------------------------------------------ #### 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 davs. 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. {12}------------------------------------------------ ### 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. {13}------------------------------------------------ | | 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 | ### Vantera® Clinical Analyzer for use with NMR LipoProfile® test Premarket Notification 510(k) Section 6 – 510(k) Summary · . {14}------------------------------------------------ | | HDL-C (mg/dL) | | | | | | TG (mg/dL) | | | | | |----------------|---------------|-----------|-----------|-----------|-----------|----------------|------------|-----------|-----------|-----------|-------------| | Pool # | 1 | 8 | 4 | 10 | 11 | Pool # | 2 | 4 | 3 | 6 | 9 | | NMR 8001 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | NMR 8001 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | | Mean (mg/dL) | 21.5 | 33.4 | 53.7 | 80.1 | 92.1 | Mean (mg/dL) | 66.1 | 70.3 | 133.5 | 153.5 | 343.3 | | n | 60 | 60 | 60 | 60 | 60 | n | 60 | 60 | 59 | 60 | 60 | | SD (mg/dL) | 0.75 | 1.39 | 1.81 | 3.70 | 2.61 | SD (mg/dL) | 1.84 | 2.15 | 4.35 | 5.92 | 7.09 | | CV (%) | 3.5 | 4.2 | 3.4 | 4.6 | 2.8 | CV (%) | 2.8 | 3.1 | 3.3 | 3.9 | 2.1 | | min (mg/dL) | 20 | 30 | 49 | 74 | 87 | min (mg/dL) | 61 | 64 | 120 | 129 | 321 | | max (mg/dL) | 23 | 36 | 57 | 88 | 97 | max (mg/dL) | 69 | 73 | 141 | 163 | 356 | | median (mg/dL) | 21.5 | 34 | 54 | 78.5 | 92 | median (mg/dL) | 66 | 71 | 134 | 155 | 345 | | NMR 8002 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | NMR 8002 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | | Mean (mg/dL) | 19.4 | 29.2 | 52.3 | 72.9 | 87.5 | Mean (mg/dL) | 70.3 | 74.6 | 141.4 | 169.7 | 361.1 | | n | 59 | 60 | 60 | 60 | 60 | n | 59 | 60 | 59 | 60 | 60 | | SD (mg/dL) | 0.68 | 1.13 | 1.34 | 1.49 | 1.28 | SD (mg/dL) | 1.30 | 1.59 | 3.03 | 3.10 | 5.01 | | CV (%) | 3.5 | 3.9 | 2.6 | 2.0 | 1.5 | CV (%) | 1.8 | 2.1 | 2.1 | 1.8 | 1.4 | | min (mg/dL) | 17 | 27 | 48 | 70 | 85 | min (mg/dL) | 68 | 72 | 131 | 160 | 341 | | max (mg/dL) | 21 | 31 | 56 | 76 | 90 | max (mg/dL) | 74 | 82 | 149 | 176 | 372 | | median (mg/dL) | 19 | 29 | 52 | 73 | 88 | median (mg/dL) | 70 | 74 | 142 | 170 | 361 | | NMR 8003 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | NMR 8003 | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | | Mean (mg/dL) | 19.4 | 28.3 | 49.9 | 74.4 | 84.9 | Mean (mg/dL) | 66.5 | 70.4 | 134.3 | 160.9 | 339.8 | | n | 58 | 60 | 60 | 60 | 60 | n | 60 | 60 | 60 | 60 | 60 | | SD (mg/dL) | 0.90 | 1.41 | 2.36 | 4.26 | 3.39 | SD (mg/dL) | 2.70 | 3.44 | 4.77 | 7.10 | 18.50 | | CV (%) | 4.6 | 5.0 | 4.7 | 5.7 | 4.0 | CV (%) | 4.1 | 4.9 | 3.5 | 4.4 | 5.4 | | min (mg/dL) | 17 | 24 | 41 | 66 | 72 | min (mg/dL) | 57 | 58 | 119 | 123 | 267 | | max (mg/dL) | 21 | 31 | 53 | 83 | 89 | max (mg/dL) | 71 | 74 | 145 | 169 | 357 | | median (mg/dL) | 19 | 28 | 50 | 73 | 86 | median (mg/dL) | 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 | Panel 5 | | Mean (mg/dL) | 20.1 | 30.3 | 52.0 | 75.8 | 88.2 | Mean (mg/dL) | 67.6 | 71.8 | 136.4 | 161.4 | 348.0 | | n | 177 | 180 | 180 | 180 | 180 | n | 179 | 180 | 178 | 180 | 180 | | SD (mg/dL) | 1.26 | 2.60 | 2.45 | 4.56 | 3.91 | SD (mg/dL) | 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 | 95% CI (mg/dL) | 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 | CV (%) | 4.1 | 4.5 | 4.0 | 5.4 | 4.3 | | min (mg/dL) | 17 | 24 | 41 | 66 | 72 | min (mg/dL) | 57 | 58 | 119 | 123 | 267 | | max (mg/dL) | 23 | 36 | 57 | 88 | 97 | max (mg/dL) | 74 | 82 | 149 | 176 | 372 | | median (mg/dL) | 19 | 28 | 50 | 73 | 86 | median (mg/dL) | 67 | 71 | 135 | 162 | 344 | #### Vantera® Clinical Analyzer for use with NMR LipoProfile® test Premarket Notification 510(k) Section 6 – 510(k) Summary {15}------------------------------------------------ ### Premarket Notification 510(k) Vantera® Clinical Analyzer for use with NMR LipoProfile® test Section 6 - 510(k) Summary ## 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: {16}------------------------------------------------ | 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 | Image /page/16/Figure/2 description: The image shows the measuring range for LDL-P, which is a type of cholesterol. The measuring range is from 300 to 3500 nmol/L. The text is in bold font. Image /page/16/Figure/3 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 line, with the equation Y=1.0193x + 7.8226 and an R-squared value of 0.9949. The x-axis represents the Target LDL-P (nmol/L) ranging from 0 to 4000, while the y-axis represents the LDL-P (nmol/L) ranging from 0 to 5000. Y=1.0193x + 7.8226, R2 = 0.9949 {17}------------------------------------------------ Vantera® Clinical Analyzer for use with NMR LipoProfile® test Premarket Notification 510(k) Section 6 - 510(k) Summary | 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 | | | HDL-C Measuring Range: 7-140 mg/dL | | | | |--|------------------------------------|--|--|--| |--|------------------------------------|--|--|--| Image /page/17/Figure/3 description: The image is a linearity plot showing HDL-C (mg/dL) on the y-axis and Target HDL-C (mg/dL) on the x-axis. There are two trendlines on the plot, one representing a linear fit with the equation (-0.3459 +1.049x) and the other representing a polynomial fit with the equation (-0.4884 +0.954x +0.003017x² -1.7074E-005x³). The equation Y= 1.0486x - 0.3459 and R² = 0.9961 are also included in the image. Y=1.0486x - 0.3459, R2 = 0.9961 {18}------------------------------------------------ | 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 | Image /page/18/Figure/2 description: The image shows the text "Triglycerides Measuring Range: 5-1100 mg/dL". This text indicates the range of values that can be measured for triglycerides, which are a type of fat in the blood. The measuring range is from 5 to 1100 milligrams per deciliter (mg/dL). Image /page/18/Figure/3 description: The image is a linearity plot showing the relationship between target TG and TG. The x-axis represents the target TG in mg/dL, ranging from 0 to 1400, while the y-axis represents TG in mg/dL, also ranging from 0 to 1400. The plot includes a linear fit with the equation y = -0.3979 + 1.008x and a polynomial fit with the equation y = 0.7793 + 0.9864x + 4.9793E-005x^2 - 2.6257E-008x^3. = 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 | LipoScience, Inc. {19}------------------------------------------------ Traceability, Stability, Assigned values (controls, calibrators) ### The NMR Reference Standard The NMR Reference Standard, TMA (Trimethylacetic acid, Sodium salt), is used as the NMR calibrator for the Vantera Clinical Analyzer. TMA is used routinely as a calibrator once daily during instrument startup to establish daily normalization factors. It also serves as a quality assessment tool to ensure quality NMR spectra are produced by the NMR analyzer. The stability of the TMA calibrator material and storage conditions was evaluated for a period of 18 months across multiple NMR Analyzers. It was stored at room temperature and refrigerated at 4°C, in glass bottles and plastic bottles. TMA samples were evaluated for TMA signal methyl integrals every other month. The quality of the TMA spectra was not affected by the storage conditions during the study. The NMR Reference Standard is stable for 18 months in either glass or plastic bottle regardless of room temperature or refrigerated storage. Liquichek™ Lipids Control Liquichek™ Lipids Control material for LDL-P is frozen human serum in two pools, Level 1 and Level 2, prepared and packaged by Bio-Rad Laboratories. To assign values, new lots of Liquicheck™ Lipids Control material are run on 3 qualified Vantera Clinical Analyzers in house for 3 days. Means. Standard Deviations and % CVs are computed and new values are assigned. The Liquicheck™ Lipids Control material is stable up to 6 months. Change in recovery over this period was estimated to be less than 0-6% for LDL-P. {20}------------------------------------------------ ## 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 | ・・。 {21}------------------------------------------------ #### 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. Vantera vs. NMR Profiler LDL-P Linear Regression Plot (n=1483) Image /page/21/Figure/5 description: This scatter plot compares Vantera LDL-P to NMR Profiler LDL-P, with values ranging from 0 to 4000 on both axes. The plot includes a line of identity and a linear fit line represented by the equation y = -36.60 + 1.03x. Additionally, the plot displays 95% confidence interval bands around the linear fit. Y=1.03x - 36.60 r=0.978 {22}------------------------------------------------ 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. Vantera vs. NMR Profiler HDL-C Linear Regression Plot (n=1518) Image /page/22/Figure/4 description: This image is a scatter plot with a linear fit. The x-axis is labeled "NMR Profiler HDL-C", and the y-axis is labeled "Vantera HDL-C". The plot shows a strong positive correlation between the two variables. The equation of the linear fit is Y=1.04x-1.20, and the correlation coefficient is r=0.989. . . {23}------------------------------------------------ ## 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. Image /page/23/Figure/3 description: The image shows the title of a plot. The title says "Vantera vs. NMR Profiler TG Linear Regression Plot (n=1520)". This indicates that the plot is a linear regression plot comparing Vantera and NMR Profiler for TG (triglycerides) with a sample size of 1520. Image /page/23/Figure/4 description: The image is a scatter plot titled "Scatter Plot with Fit". The x-axis is labeled "NMR Profiler TG" and ranges from 0 to 1200. The y-axis is labeled "Vantera TG" and ranges from 0 to 1200. The plot shows a strong positive correlation between the two variables, with data points clustered tightly around a linear fit line represented by the equation (0.92 + 1.00x). Y=1.00x + 0.92 r=0.998 {24}------------------------------------------------ #### Standard/Guidance Documents Referenced (if applicable): K. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approves Guideline - Second Edition EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition EP9-A2: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline EP14-A2: Evaluation of Matrix Effects: Approved Guideline - Second Edition C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical C53-A: Characterization and Oualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline IEC 61010-1:2001-2nd Edition: Safety requirements for electrical equipment for measurement, control and laboratory use Part: General requirements This device has not been tested by the Cholesterol Reference Method Laboratory Network. #### M. Clinical Studies: - Clinical Sensitivity: a. Not Applicable - Clinical specificity: b. Not Applicable {25}------------------------------------------------ - Other clinical supportive data (when a. and b. are not applicable): c. : . Not Applicable - l. Clinical cut-off: Not Applicable - 2. 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…

VANTERA CLINICAL ANALYZER

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

VANTERA CLINICAL ANALYZER

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!