Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard NMR spectral analysis and deconvolution techniques, without mentioning AI or ML algorithms for data processing or interpretation.

Therapeutic

No
The device is an automated laboratory test analyzer used for diagnostic purposes by measuring analytes in clinical samples; it does not provide any therapeutic function.

Diagnostic

Yes

The device measures multiple analytes from clinical samples to aid in the management of lipoprotein disorders associated with cardiovascular disease, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Vantera Clinical Analyzer system design is divided into 3 major subassemblies: a sample handling assembly, an NMR subassembly, and an enclosure, in addition to the software components. This indicates the presence of significant hardware.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is an "automated laboratory test analyzer which measures... clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration." It is used with "NMR based assays to detect multiple analytes from clinical samples." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Specific Test: The description of the NMR LipoProfile test further clarifies its IVD nature. It measures lipoprotein particles (LDL-P, HDL-C, triglycerides) in human serum and plasma, and these measurements are 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 clear diagnostic purpose.
Device Description: The device description confirms it analyzes "biological fluid specimens, specifically blood plasma and serum," which are clinical samples.
Performance Studies and Key Metrics: The inclusion of analytical validation performance testing, including precision, method comparison, linearity, limits of detection, interference, and carryover studies, along with key metrics like measuring range, LoB, LoD, LoQ, linearity, precision, and method comparison results, are all standard elements of IVD device documentation to demonstrate analytical performance for diagnostic use.
Predicate Device: The mention of a predicate device (K113830; NMR LipoProfile test on Vantera Clinical Analyzer) further indicates that this device is being compared to a previously cleared IVD.

In summary, the device's intended use, the specific test it performs on clinical samples for diagnostic purposes, and the type of performance data provided all strongly indicate that it is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

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

NSU, MRR, LBS, CDT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Nuclear magnetic resonance (NMR) spectroscopy

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Automated laboratory test 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

Not Found

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

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

LDL-P (nmol/L) - Candidate Device

Measuring Range: 300-3500
LoB: 0
LoD: 50.1
LoQ: 154.7
Linearity Regression: y= 0.99x + 106.6
Linearity R²: 0.997
Linear Range: 290 - 3524
Within-Run Precision (Level 1 Mean/SD/CV%): 706.2/54.63/7.7
Within-Run Precision (Level 2 Mean/SD/CV%): 1308.6/72.85/5.5
Within-Run Precision (Level 3 Mean/SD/CV%): 2249.9/58.35/2.6
Within-Lab Precision (Level 1 Mean/SD/CV%): 729.0/50.8/7.0
Within-Lab Precision (Level 2 Mean/SD/CV%): 1338.2/88.69/6.8
Within-Lab Precision (Level 3 Mean/SD/CV%): 2234.4/59.92/2.7
Method Comparison: Deming fit: y= 43.44 + 0.98x r = 0.988
Medical Decision Limits: same [as predicate: 1000, 1300 and 1600]
Sample Type: same [as predicate: Serum and Plasma]
Carryover: same [as predicate: No significant trending of the results and no persistent bias relative to the reference mean for either the low or high pools]
Interference Study: 7 Endogenous and 23 Exogenous substances were tested. Clopidogrel (Plavix) interferes with test results at the therapeutic doses of 95.7 µmol/L. Salicylic acid interferes with test results at therapeutic doses of 1.3 mmol/L. Fenofibrate interferes with test results at therapeutic doses of 31 µmol/L. Menhaden oil interferes with test results at therapeutic doses of 0.6 mg/mL. for either the low or high pools.

TG (mg/dL) - Candidate Device

Measuring Range: 10 - 1100
LoB: 1.2
LoD: 2.3
LoQ: 4.8
Linearity Regression: y= 1.01x - 1.7
Linearity R²: 1.0
Linear Range: 4 - 1355
Within-Run Precision (Level 1 Mean/SD/CV%): 72.4/1.93/2.7
Within-Run Precision (Level 2 Mean/SD/CV%): 168.3/1.55/0.9
Within-Run Precision (Level 3 Mean/SD/CV%): 286.1/1.62/0.6
Within-Lab Precision (Level 1 Mean/SD/CV%): 71.4/2.39/3.3
Within-Lab Precision (Level 2 Mean/SD/CV%): 162.4/2.44/1.5
Within-Lab Precision (Level 3 Mean/SD/CV%): 274.9/6.94/2.5
Method Comparison: Deming fit: Y= 1.01x +0.30 r=1.00
Sample Type: Serum and Plasma
Carryover: same [as predicate: No significant trending of the results and no persistent bias relative to the reference mean for either the low or high pools.]
Interference Study: same [as predicate: 7 Endogenous and 23 Exogenous substances were tested, no interference was found]

HDL-C (mg/dL) - Candidate Device

Measuring Range: 7 - 140
LoB: 3.2
LoD: 4.4
LoQ: 4.4
Linearity Regression: y= 1.02x - 0.63
Linearity R²: 1.0
Linear Range: 5 - 168
Within-Run Precision (Level 1 Mean/SD/CV%): 28.75/0.44/1.5
Within-Run Precision (Level 2 Mean/SD/CV%): 55.2/0.41/0.7
Within-Run Precision (Level 3 Mean/SD/CV%): 90.0/1.62/1.8
Within-Lab Precision (Level 1 Mean/SD/CV%): 27.0/0.71/2.7
Within-Lab Precision (Level 2 Mean/SD/CV%): 52.4/1.02/1.9
Within-Lab Precision (Level 3 Mean/SD/CV%): 87.9/2.52/2.9
Method Comparison: Deming fit: y= -1.36 + 1.01x - r=0.998
Sample Type: Serum and Plasma
Carryover: same [as predicate: No significant trending of the results and no persistent bias relative to the reference mean for either the low or high pools.]
Interference Study: same [as predicate: 7 Endogenous and 23 Exogenous substances were tested, no interference was found.]

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

See "Summary of Performance Studies" for detailed precision, linearity, and method comparison results including SD, CV%, regression equations, and R² values.

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.

K113830

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.2570 Instrumentation for clinical multiplex test systems.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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.

1

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K133849

C LIPOSCIENCE

I. SUBMITTER

LipoScience, Inc. 2500 Sumner Boulevard Raleigh, NC 27616

Phone: (919) 256-1326 Fax: (919) 256-1149

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

4

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.

5

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.

6

| | Vantera Clinical Analyzer
(Predicate) | Vantera Clinical Analyzer
(Candidate Device) |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Similarities | | |
| 510(k) Number | K113830 | K133849 |
| Intended Use /
Indications for
Use (Assay) | 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. | same |
| Instrument
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. | same |
| Technology | Nuclear magnetic resonance | same |
| User Interface | Touch Screen GUI | same |
| System Bulk
Fluids | Stored on board | same |
| Specimen
Sampling and
Handling | Serum/Plasma Samples are diluted
onboard system | same |
| System Calibration | System calibration required to assess and
correct homogeneity of the magnetic field | same |
| | Vantera Clinical Analyzer
(Predicate) | Vantera Clinical
Analyzer
(Candidate Device) |
| Safety Standards
for Electrical
Equipment | IEC 61010-1: 2001 2nd Edition | same |
| Specimen
Identification | Barcode reader entry of sample ID | same |
| Materials
(Consumables) | Diluent 1, WASH, NMR Reference
Standard, Liquicheck Lipid Controls | same |
| | Differences | |
| NMR Console | MR-400 | MR-400-DD2 |
| NMR Control
Software | VnmrJ Software v3.0
Operating System: Linux 5.3 | VnmrJ Software v3.2
Operating System: Linux
RHEL6.3 |
| Instrument
Enclosure | Sheet Metal and Fiberglass | Sheet Metal and
polyurethane |
| Cryogen Monitor | Separate helium and nitrogen monitors | Combination of helium
monitor and nitrogen
monitor into one unit |
| Fluidics Daughter
Board | No rinse pump feedback monitoring | Rinse pump tachometer
used to monitor rinse
pump |

7

8

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

| LDL-P (nmol/L) (Predicate Device) relative to the reference mean
for either the low or high pools | Interference Study Exogenous substances were
tested. Salicylic 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 | substances were tested.
Clopidogrel (Plavix) interferes test results at the therapeutic of 95.7 µmol/L
Salicylic acid interferes results at therapeutic mmol/L.
Fenofibrate interferes with test
results at therapeutic doses of 31
µmol/L.
Menhaden oil interferes with test
results at therapeutic mg/mL. for either the low or high pools | | Vantera Clinical Analyzer
href="https://510k.innolitics.com/search/K113830" target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K113830 | Vantera Clinical Analyzer
| | |
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| 300-3500 | | | | |
| 0 | | | | |
| 50.1 | | | | |
| 154.7 | | | | |
| y= 1.02x + 7.82 | y= 0.99x + 106.6 | | | | |
| 0.997 | | | | |
| 290 - 3524 | | | | |
| Level 2 | Level 3 | Level
| Level 2 | Level 3 |
| 1309.5 | 1837.7 | 706.2 | 1308.6 | 2249.9 |
| 39.1 | 50.3 | 54.63 | 72.85 | 58.35 |
| 3.0 | 2.7 | 7.7 | 5.5 | 2.6 |
| Level 2 | Level 3 | Level
| Level 2 | Level 3 |
| 1266.7 | 1943.5 | 729.0 | 1338.2 | 2234.4 |
| 32.57 | 63.42 | 50.8 | 88.69 | 59.92 |
| 4.0 | 3.9 | 7.0 | 6.8 | 2.7 |
| Linear regression:
| | | Deming fit:
| | |
| 1000, 1300 and 1600 | | | same | | |
| Serum and Plasma | | | same | | |
| No significant trending of the
| | | same | | |
| 7 Endogenous and 23
| | 7 Endogenous and 23 Exogenous
with
doses
with test
doses of 1.3
doses of 0.6
| |

9

| TG (mg/dL) | | Vantera Clinical Analyzer
(Predicate Device) K113830 | Vantera Clinical Analyzer
(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
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
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:
$y=1.00x + 0.92, r=0.998$ | | | Deming fit:
$Y= 1.01x +0.30 r=1.00$ | | |
| Sample Type | | Serum and Plasma | | | Serum and Plasma | | |
| Carryover | | No significant trending of the results
and no persistent bias relative to the
reference mean for either the low or
high pools. | | | same | | |
| Interference Study | | 7 Endogenous and 23 Exogenous
substances were tested, no
interference was found | | | same | | |

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| HDL-C (mg/dL) | Vantera Clinical Analyzer
(Predicate Device) K113830 | Vantera Clinical Analyzer
(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:
$y=1.04x-1.20, r=0.989$ | | | Deming fit:
$y= -1.36 + 1.01x - r=0.998$ | | |
| Sample Type | Serum and Plasma | | | Serum and Plasma | | |
| Carryover | No significant trending of the
results and no persistent bias
relative to the reference mean for
either the low or high pools. | | | same | | |
| Interference Study | 7 Endogenous and 23 Exogenous
substances were tested, no
interference was found. | | | same | | |

11

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.