VANTERA CLINICAL ANALYZER

K133849 · Liposcience · NSU · Oct 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133849
• Device Name: VANTERA CLINICAL ANALYZER
• Applicant: Liposcience
• Product Code: NSU · Clinical Chemistry
• Decision Date: Oct 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

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; fully automated in vitro diagnostic system; utilizes NMR spectroscopy for analyte measurement in human serum/plasma. Modification includes updates to NMR console (magnet, probe, RF transmitter/receiver), fluidics system, software version, sample handling, cryogen monitor, WASH barcode reader, and addition of rinse pump tachometer. Operated by trained laboratory professionals in clinical laboratory environments. Device transforms NMR signals into qualitative/semi-quantitative analyte data. Output used by clinicians for diagnostic decision-making. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and comparative performance verification between modified and predicate systems.

Technological Characteristics

NMR spectroscopy-based analyzer. Components: NMR console (magnet, probe, RF transmitter/receiver), fluidics system, sample handling system, cryogen monitor, barcode reader, rinse pump tachometer. Risk management per ISO 14971. Software-controlled automation.

Indications for Use

Indicated for use in clinical laboratories to measure lipoprotein particles (LDL-P, HDL-C, and triglycerides) in human serum and plasma to aid in the management of lipoprotein disorders associated with cardiovascular disease.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an 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. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Vantera Clinical Analyzer (K113830)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 22, 2014

LIPOSCIENCE, INC. SUZETTE WARNER SENIOR MANAGER, REGULATORY AFFAIRS 2500 SUMNER BLVD. RALEIGH NC 27616

Re: K133849

Trade/Device 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: II Product Code: NSU, MRR, LBS, CDT Dated: September 19, 2014 Received: September 22, 2014

Dear Ms. Suzette Warner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K133849

#### Device Name

Vantera® Clinical Analyzer, NMR LipoProfile® test on Vantera® Clinical Analyzer

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|--|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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#### 510(k) Summary K133849

## C LIPOSCIENCE

#### I. SUBMITTER

LipoScience, Inc. 2500 Sumner Boulevard Raleigh, NC 27616

Phone: [phone] Fax: [phone]

Contact Person: Suzette Warner

Date Prepared: September 18, 2014

## II. DEVICE

Name of Device: Vantera® Clinical Analyzer Common Name: NMR LipoProfile® test on Vantera® Clinical Analyzer 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 Triglyceride test system, 21 CFR 862.1705, Product Code CDT

Clinical Chemistry (75) Panel:

#### III. PREDICATE DEVICE

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

NMR LipoProfile test on Vantera Clinical Analyzer k113830

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# IV. DEVICE DESCRIPTION

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 (1 U) 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.
- The NMR Control Computer controls all magnet operations. Two of these computers are contained within the Sample Handling Subassembly (1 U and 4U) and one in the NMR Subassembly (NMR Console).

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.

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# V. 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.

## For the Asaay

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 NMRderived 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.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modified Vantera Clinical Analyzer is as safe and effective as the predicate device, k113830. The Vantera has the same intended use as the predicate device. The differences between the candidate device and the predicate device raise no new issues of safety or effectiveness.

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| | Vantera Clinical Analyzer<br>(Predicate) | Vantera Clinical Analyzer<br>(Candidate Device) |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Similarities | | |
| 510(k) Number | K113830 | K133849 |
| Intended Use /<br>Indications for<br>Use (Assay) | The NMR LipoProfile® test, when used<br>with the Vantera® Clinical Analyzer, an<br>automated NMR spectrometer, measures<br>lipoprotein particles to quantify LDL<br>particle number (LDL-P), HDL<br>cholesterol (HDL-C), and triglycerides in<br>human serum and plasma using nuclear<br>magnetic resonance (NMR) spectroscopy.<br>LDL-P and these NMR-derived<br>concentrations of HDL-C and<br>triglycerides are used in conjunction with<br>other lipid measurements and clinical<br>evaluation to aid in the management of<br>lipoprotein disorders associated with<br>cardiovascular disease. | same |
| Instrument<br>Intended Use | The Vantera® Clinical Analyzer is an<br>automated laboratory test analyzer which<br>measures the 400 MHz proton nuclear<br>magnetic resonance (NMR) spectrum of<br>clinical samples to produce signal<br>amplitudes, converting these signal<br>amplitudes to analyte concentration. The<br>device includes a 400 MHz NMR<br>spectrometer and software to analyze<br>digitized spectral data. This<br>instrumentation is intended to be used<br>with NMR based assays to detect<br>multiple analytes from clinical samples. | same |
| Technology | Nuclear magnetic resonance | same |
| User Interface | Touch Screen GUI | same |
| System Bulk<br>Fluids | Stored on board | same |
| Specimen<br>Sampling and<br>Handling | Serum/Plasma Samples are diluted<br>onboard system | same |
| System Calibration | System calibration required to assess and<br>correct homogeneity of the magnetic field | same |
| | Vantera Clinical Analyzer<br>(Predicate) | Vantera Clinical<br>Analyzer<br>(Candidate Device) |
| Safety Standards<br>for Electrical<br>Equipment | IEC 61010-1: 2001 2nd Edition | same |
| Specimen<br>Identification | Barcode reader entry of sample ID | same |
| Materials<br>(Consumables) | Diluent 1, WASH, NMR Reference<br>Standard, Liquicheck Lipid Controls | same |
| | Differences | |
| NMR Console | MR-400 | MR-400-DD2 |
| NMR Control<br>Software | VnmrJ Software v3.0<br>Operating System: Linux 5.3 | VnmrJ Software v3.2<br>Operating System: Linux<br>RHEL6.3 |
| Instrument<br>Enclosure | Sheet Metal and Fiberglass | Sheet Metal and<br>polyurethane |
| Cryogen Monitor | Separate helium and nitrogen monitors | Combination of helium<br>monitor and nitrogen<br>monitor into one unit |
| Fluidics Daughter<br>Board | No rinse pump feedback monitoring | Rinse pump tachometer<br>used to monitor rinse<br>pump |

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Performance data further demonstrate that the Vantera Clinical Analyzer is as safe and effective as its predicate, k11383.

| LDL-P (nmol/L) | Vantera Clinical Analyzer<br>(Predicate Device) k113830 | Vantera Clinical Analyzer<br>(Candidate Device) | | | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| Measuring Range | 300 - 3500 | 300-3500 | | | | |
| LoB | 0 | 0 | | | | |
| LoD | 40.7 | 50.1 | | | | |
| LoQ | 132 | 154.7 | | | | |
| Linearity Regression | y= 1.02x + 7.82 | y= 0.99x + 106.6 | | | | |
| Linearity R² | 0.995 | 0.997 | | | | |
| Linear Range | 225 - 4322 | 290 - 3524 | | | | |
| Within-Run Precision | Level 1 | Level 2 | Level 3 | Level<br>1 | Level 2 | Level 3 |
| Mean | 842.6 | 1309.5 | 1837.7 | 706.2 | 1308.6 | 2249.9 |
| SD | 48.5 | 39.1 | 50.3 | 54.63 | 72.85 | 58.35 |
| CV% | 5.8 | 3.0 | 2.7 | 7.7 | 5.5 | 2.6 |
| Within-Lab Precision | Level 1 | Level 2 | Level 3 | Level<br>1 | Level 2 | Level 3 |
| Mean | 988.6 | 1266.7 | 1943.5 | 729.0 | 1338.2 | 2234.4 |
| SD | 48.84 | 32.57 | 63.42 | 50.8 | 88.69 | 59.92 |
| CV% | 5.3 | 4.0 | 3.9 | 7.0 | 6.8 | 2.7 |
| Method Comparison | Linear regression:<br>y=1.03x - 36.60, r=0.978 | | | Deming fit:<br>y= 43.44 + 0.98x r = 0.988 | | |
| Medical Decision Limits | 1000, 1300 and 1600 | | | same | | |
| Sample Type | Serum and Plasma | | | same | | |
| Carryover | No significant trending of the<br>results and no persistent bias<br>relative to the reference mean<br>for either the low or high pools | | | same | | |
| Interference Study | 7 Endogenous and 23<br>Exogenous substances were<br>tested. Salicylic acid at ≥<br>1.3mmol/L was determined to<br>interfere with LDL-P and<br>Clopidogrel hydrogensulfate at<br>≥ 95.7 µmol/L was determined<br>to interfere with LDL-P | | | 7 Endogenous and 23 Exogenous<br>substances were tested.<br>Clopidogrel (Plavix) interferes with<br>test results at the therapeutic doses<br>of 95.7 µmol/L<br>Salicylic acid interferes with test<br>results at therapeutic doses of 1.3<br>mmol/L.<br>Fenofibrate interferes with test<br>results at therapeutic doses of 31<br>µmol/L.<br>Menhaden oil interferes with test<br>results at therapeutic doses of 0.6<br>mg/mL. for either the low or high pools | | |

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| TG (mg/dL) | | Vantera Clinical Analyzer<br>(Predicate Device) k113830 | Vantera Clinical Analyzer<br>(Candidate Device) | | | | |
|-------------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------|----------------------------------------|---------|--|
| Measuring Range | | 5- 1100 | 10 - 1100 | | | | |
| LoB | | 1.1 | 1.2 | | | | |
| LoD | | 2.3 | 2.3 | | | | |
| LoQ | | 4 | 4.8 | | | | |
| Linearity Regression | | $y= 1.01x - 0.40$ | $y= 1.01x - 1.7$ | | | | |
| Linearity R² | | 1.0 | 1.0 | | | | |
| Linear Range | | 4 - 1346 | 4 - 1355 | | | | |
| Within-Run<br>Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Mean | 70.1 | 169.2 | 356.1 | 72.4 | 168.3 | 286.1 | |
| SD | 1.6 | 3.5 | 4.2 | 1.93 | 1.55 | 1.62 | |
| CV% | 2.3 | 2.1 | 1.2 | 2.7 | 0.9 | 0.6 | |
| Within-Lab<br>Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Mean | 68.8 | 166.3 | 352.2 | 71.4 | 162.4 | 274.9 | |
| SD | 1.59 | 3.92 | 9.36 | 2.39 | 2.44 | 6.94 | |
| CV% | 2.3 | 2.4 | 2.7 | 3.3 | 1.5 | 2.5 | |
| Method Comparison | | Linear regression:<br>$y=1.00x + 0.92, r=0.998$ | | | Deming fit:<br>$Y= 1.01x +0.30 r=1.00$ | | |
| Sample Type | | Serum and Plasma | | | Serum and Plasma | | |
| Carryover | | No significant trending of the results<br>and no persistent bias relative to the<br>reference mean for either the low or<br>high pools. | | | same | | |
| Interference Study | | 7 Endogenous and 23 Exogenous<br>substances were tested, no<br>interference was found | | | same | | |

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| HDL-C (mg/dL) | Vantera Clinical Analyzer<br>(Predicate Device) k113830 | Vantera Clinical Analyzer<br>(Candidate Device) | | | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------|---------------------------------------------|---------|---------|
| Measuring Range | 7 - 140 | 7 - 140 | | | | |
| LoB | 2.7 | 3.2 | | | | |
| LoD | 3.5 | 4.4 | | | | |
| LoQ | 4 | 4.4 | | | | |
| Linearity Regression | $y= 1.04x - 0.35$ | $y= 1.02x - 0.63$ | | | | |
| Linearity R² | 1.0 | 1.0 | | | | |
| Linear Range | 6 - 148 | 5 - 168 | | | | |
| Within-Run Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean | 29.1 | 51.1 | 86.9 | 28.75 | 55.2 | 90.0 |
| SD | 1.17 | 1.43 | 2.29 | 0.44 | 0.41 | 1.62 |
| CV% | 4.0 | 2.8 | 2.6 | 1.5 | 0.7 | 1.8 |
| Within-Lab Precision | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean | 28.9 | 50.7 | 85.2 | 27.0 | 52.4 | 87.9 |
| SD | 0.80 | 1.02 | 1.51 | 0.71 | 1.02 | 2.52 |
| CV% | 2.8 | 2.0 | 1.8 | 2.7 | 1.9 | 2.9 |
| Method Comparison | Linear regression:<br>$y=1.04x-1.20, r=0.989$ | | | Deming fit:<br>$y= -1.36 + 1.01x - r=0.998$ | | |
| Sample Type | Serum and Plasma | | | Serum and Plasma | | |
| Carryover | No significant trending of the<br>results and no persistent bias<br>relative to the reference mean for<br>either the low or high pools. | | | same | | |
| Interference Study | 7 Endogenous and 23 Exogenous<br>substances were tested, no<br>interference was found. | | | same | | |

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# VII. CONCLUSION

A risk analysis was performed to identify any new risks due to the hardware and software modifications to device. Based on this risk analysis, verification and validation testing was performed that included software verification and validation testing, as well as analytical validation studies. This verification and validation testing included:

- . Software validation testing to ensure that hardware and software modifications to the device did not affect the sample handling performance of the device.
- Analytical validation performance testing to ensure that the hardware and . software modifications did not affect the accuracy of test results. This testing included precision, method comparison, linearity, limits of detection, interference and carry over studies.

The results of these verification and validation studies support that the performance of the modified device is substantially equivalent to that of the predicate device and that the differences in performance do not impact the safe use of the device.