(307 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Vantera Clinical Analyzer and NMR LipoProfile® test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113830) rather than explicitly stating pre-defined "acceptance criteria" for novel performance features. However, the comparisons in the tables serve as the de-facto acceptance criteria: the candidate device's performance must be comparable to or better than the predicate device across various analytical metrics.
| Metric (Analyte) | Predicate Device (K113830) Performance | Candidate Device Performance |
|---|---|---|
| LDL-P (nmol/L) | ||
| 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 (CV%) | Level 1: 5.8, Level 2: 3.0, Level 3: 2.7 | Level 1: 7.7, Level 2: 5.5, Level 3: 2.6 |
| Within-Lab Precision (CV%) | Level 1: 5.3, Level 2: 4.0, Level 3: 3.9 | Level 1: 7.0, Level 2: 6.8, Level 3: 2.7 |
| Method Comparison | Linear regression: y=1.03x - 36.60, r=0.978 | Deming fit: 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 results and no persistent bias | same |
| Interference Study | Salicylic acid at ≥ 1.3mmol/L, Clopidogrel hydrogensulfate at ≥ 95.7 µmol/L | Clopidogrel (Plavix) at 95.7 µmol/L, Salicylic acid at 1.3 mmol/L, Fenofibrate at 31 µmol/L, Menhaden oil at 0.6 mg/mL. (Note: Candidate device lists more interferences than predicate for LDL-P) |
| TG (mg/dL) | ||
| 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 (CV%) | Level 1: 2.3, Level 2: 2.1, Level 3: 1.2 | Level 1: 2.7, Level 2: 0.9, Level 3: 0.6 |
| Within-Lab Precision (CV%) | Level 1: 2.3, Level 2: 2.4, Level 3: 2.7 | Level 1: 3.3, Level 2: 1.5, Level 3: 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 | same |
| Carryover | No significant trending of results and no persistent bias | same |
| Interference Study | 7 Endogenous and 23 Exogenous substances tested, no interference found | same (no interference found with 7 Endogenous and 23 Exogenous substances) |
| HDL-C (mg/dL) | ||
| 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 (CV%) | Level 1: 4.0, Level 2: 2.8, Level 3: 2.6 | Level 1: 1.5, Level 2: 0.7, Level 3: 1.8 |
| Within-Lab Precision (CV%) | Level 1: 2.8, Level 2: 2.0, Level 3: 1.8 | Level 1: 2.7, Level 2: 1.9, Level 3: 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 | same |
| Carryover | No significant trending of results and no persistent bias | same |
| Interference Study | 7 Endogenous and 23 Exogenous substances tested, no interference found | same (no interference found with 7 Endogenous and 23 Exogenous substances) |
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the specific sample sizes for each analytical validation study for the "test set" in terms of number of patient samples. It mentions "Level 1, Level 2, Level 3" for precision studies, implying control samples at different concentrations. For linearity, there are ranges of values. For the method comparison, it gives regression parameters, which typically require a reasonable number of samples, but the exact count isn't specified.
The data provenance (country of origin, retrospective/prospective) is not provided in the document.
3. Number of Experts and Qualifications for Ground Truth of Test Set
This information is not applicable and not provided. The device (Vantera Clinical Analyzer with NMR LipoProfile® test) is an IVD for quantitative measurement of lipoprotein particles, HDL cholesterol, and triglycerides. The ground truth for these measurements in analytical validation studies would typically be established by:
- Reference methods (e.g., ultracentrifugation for lipoproteins, enzymatic assays for cholesterol/triglycerides).
- Certified reference materials.
- Highly qualified laboratory personnel following established protocols for the reference methods.
Experts in the sense of clinical reviewers (e.g., radiologists for imaging devices) are not typically involved in establishing ground truth for this type of analytical device.
4. Adjudication Method for the Test Set
Not applicable. This is not a human interpretation-based diagnostic device requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an automated analytical laboratory device, not an imaging or interpretation aid for human readers. Therefore, an MRMC study and effects of AI assistance on human readers are not relevant.
6. Standalone Performance Study
Yes, the studies presented are standalone (algorithm only) performance studies. The results in the tables (Measuring Range, LoB, LoD, LoQ, Linearity, Precision, Method Comparison, Carryover, Interference) directly reflect the performance of the Vantera Clinical Analyzer and NMR LipoProfile® test itself, without any human-in-the-loop interaction for interpretation, beyond the standard operation of an automated laboratory instrument.
7. Type of Ground Truth Used
The ground truth for the analytical validation studies would be established using reference methods or reference materials. For example:
- Method Comparison: Comparison against a recognized reference method for lipoprotein quantification, HDL-C, and triglycerides. While not explicitly stated, standard practice would involve a comparison to a well-characterized, clinically accepted method. The "Deming fit" and "Linear regression" indicate comparison to another quantitative measurement.
- Linearity, LoB, LoD, LoQ: These are typically established using characterized control materials (known concentrations) or serial dilutions of patient samples.
- Precision: Established using control materials at different concentrations.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. This device is an analytical instrument based on Nuclear Magnetic Resonance (NMR) spectroscopy and a deconvolution analysis model. While the deconvolution model itself would have been developed and "trained" or optimized using a dataset of known NMR spectra and corresponding reference measurements, the document focuses on the validation of the integrated device. The details of the dataset used for the initial development/training of the deconvolution algorithm are not provided here.
9. How the Ground Truth for the Training Set Was Established
As above, the document does not provide details on the training set for the deconvolution model. However, for a device based on a physical principle like NMR spectroscopy, the ground truth for establishing the deconvolution model and conversion factors would likely involve:
- Carefully characterized samples with known concentrations of lipoproteins, HDL-C, and triglycerides, determined by highly accurate reference methods (e.g., ultracentrifugation for lipoprotein subfractions, established enzymatic methods for cholesterol and triglycerides).
- Spectral data from these characterized samples would be used to build and optimize the deconvolution algorithm (i.e., establish unique frequencies and lineshapes) and the conversion factors from signal amplitudes to concentrations.
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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 (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
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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(Predicate) | Vantera Clinical Analyzer(Candidate Device) | |
|---|---|---|
| Similarities | ||
| 510(k) Number | K113830 | K133849 |
| Intended Use /Indications forUse (Assay) | The NMR LipoProfile® test, when usedwith the Vantera® Clinical Analyzer, anautomated NMR spectrometer, measureslipoprotein particles to quantify LDLparticle number (LDL-P), HDLcholesterol (HDL-C), and triglycerides inhuman serum and plasma using nuclearmagnetic resonance (NMR) spectroscopy.LDL-P and these NMR-derivedconcentrations of HDL-C andtriglycerides are used in conjunction withother lipid measurements and clinicalevaluation to aid in the management oflipoprotein disorders associated withcardiovascular disease. | same |
| InstrumentIntended Use | The Vantera® Clinical Analyzer is anautomated laboratory test analyzer whichmeasures the 400 MHz proton nuclearmagnetic resonance (NMR) spectrum ofclinical samples to produce signalamplitudes, converting these signalamplitudes to analyte concentration. Thedevice includes a 400 MHz NMRspectrometer and software to analyzedigitized spectral data. Thisinstrumentation is intended to be usedwith NMR based assays to detectmultiple analytes from clinical samples. | same |
| Technology | Nuclear magnetic resonance | same |
| User Interface | Touch Screen GUI | same |
| System BulkFluids | Stored on board | same |
| SpecimenSampling andHandling | Serum/Plasma Samples are dilutedonboard system | same |
| System Calibration | System calibration required to assess andcorrect homogeneity of the magnetic field | same |
| Vantera Clinical Analyzer(Predicate) | Vantera ClinicalAnalyzer(Candidate Device) | |
| Safety Standardsfor ElectricalEquipment | IEC 61010-1: 2001 2nd Edition | same |
| SpecimenIdentification | Barcode reader entry of sample ID | same |
| Materials(Consumables) | Diluent 1, WASH, NMR ReferenceStandard, Liquicheck Lipid Controls | same |
| Differences | ||
| NMR Console | MR-400 | MR-400-DD2 |
| NMR ControlSoftware | VnmrJ Software v3.0Operating System: Linux 5.3 | VnmrJ Software v3.2Operating System: LinuxRHEL6.3 |
| InstrumentEnclosure | Sheet Metal and Fiberglass | Sheet Metal andpolyurethane |
| Cryogen Monitor | Separate helium and nitrogen monitors | Combination of heliummonitor and nitrogenmonitor into one unit |
| Fluidics DaughterBoard | No rinse pump feedback monitoring | Rinse pump tachometerused to monitor rinsepump |
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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(Predicate Device) K113830 | Vantera Clinical Analyzer(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 | Level1 | 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 | Level1 | 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:y=1.03x - 36.60, r=0.978 | Deming fit: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 theresults and no persistent biasrelative to the reference meanfor either the low or high pools | same | ||||
| Interference Study | 7 Endogenous and 23Exogenous substances weretested. Salicylic acid at ≥1.3mmol/L was determined tointerfere with LDL-P andClopidogrel hydrogensulfate at≥ 95.7 µmol/L was determinedto interfere with LDL-P | 7 Endogenous and 23 Exogenoussubstances were tested.Clopidogrel (Plavix) interferes withtest results at the therapeutic dosesof 95.7 µmol/LSalicylic acid interferes with testresults at therapeutic doses of 1.3mmol/L.Fenofibrate interferes with testresults at therapeutic doses of 31µmol/L.Menhaden oil interferes with testresults at therapeutic doses of 0.6mg/mL. for either the low or high pools |
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| 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-RunPrecision | 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-LabPrecision | 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 resultsand no persistent bias relative to thereference mean for either the low orhigh pools. | same | |||||
| Interference Study | 7 Endogenous and 23 Exogenoussubstances were tested, nointerference 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 theresults and no persistent biasrelative to the reference mean foreither the low or high pools. | same | ||||
| Interference Study | 7 Endogenous and 23 Exogenoussubstances were tested, nointerference 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.
§ 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.