(854 days)
Not Found
No
The description focuses on NMR spectroscopy and signal deconvolution, which are traditional signal processing techniques, not AI/ML. There is no mention of AI, ML, or related concepts like training data or algorithms.
No.
The device is an in vitro diagnostic device used to measure lipoprotein particles for diagnostic purposes, not to provide therapy.
Yes
Explanation: The intended use states that the device is "intended to measure lipoprotein particles to quantify LDLp... to aid in the management of lipoprotein disorders associated with cardiovascular disease." This directly indicates a diagnostic purpose.
No
The device description explicitly states that the AXINON® LDL-p Test System includes the AXINON® Analyzer, which is a clinical laboratory analyzer employing nuclear magnetic resonance spectroscopic detection. It also mentions an "NMR workstation" that controls magnet operations and hardware in the sample handler. While software is a component, the system relies on significant hardware for data acquisition (NMR spectroscopy) and sample handling.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is "intended to measure lipoprotein particles to quantify LDLp) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample." It also states that the results are used "in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease." This clearly indicates that the device is used to test a human sample (serum) in vitro (outside the body) to provide information for medical diagnosis and management.
- Sample Type: The device analyzes "human serum sample," which is a biological specimen taken from the human body.
- Measurement Method: It uses "nuclear magnetic resonance (NMR) spectroscopy" to measure analytes in the serum sample.
- Purpose: The results are used to "aid in the management of lipoprotein disorders associated with cardiovascular disease," which is a medical purpose.
- Professional Use: The statement "This test system is for professional use only" further supports its use in a clinical or laboratory setting for diagnostic purposes.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AXINON® LDL-p Test System is intended to measure lipoprotein particles to quantify LDL particle number (LDL-p) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values 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 system is for professional use only.
Product codes (comma separated list FDA assigned to the subject device)
MRR
Device Description
The AXINON® LDL-p Test System involves measurement of the 600 MHz proton NMR spectrum of a serum sample, deconvolution of the composite signal at approximately 0.85 ppm to produce signal amplitudes of lipoprotein subclass proportions that contribute to the composite serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The 0.85 ppm serum NMR signal arises mainly from the methyl group protons of the lipids carried in the VLDL, LDL and HDL subclasses of varying diameters. The NMR signals from the various lipids within the lipoprotein subclasses have unique and distinctive shapes and frequencies, uncovered by the granular decomposition of the composite serum signal. Each of these lipid signal representatives 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).
The AXINON® LDL-p Test System including the AXINON® Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically human serum.
The AXINON® Analyzer system is distributed across two separate computers:
The workstation running AXINON® Software is the main host of the system. It controls user interfaces, data handling, results calculation, schedules and manages all activities required to process a sample, and manages remote access to the NMR system.
In addition, AXINON® Analyzer comes with the optional software utility AXINON® Sample Wizard that supports manual sample preparation procedures.
The NMR workstation controls all magnet operations and the hardware in the sample handler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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)
Linearity:
The measurement procedure shows linearity for the interval from 300 to 3100 nmol/L.
- Deviations from linearity: within ± 10% for the range from 800 to 3100 nmol/L, and within ± 80 nmol/L for the range from 300 to 800 nmol/L.
- Study Sample: 11 levels and five replicates for each level.
- Maximum observed % deviation from linearity: 23.2% (at 219 nmol/L).
- Maximum observed absolute deviation: 126.7 nmol/L (at 3285 nmol/L).
Precision:
- Study Type: Within-run imprecision and within-lab precision.
- Study Design: Six concentration levels, measured in duplicates in two runs each day over a period of 20 days with three lots of reagents.
- Key Results:
- Repeatability (Within-run precision):
- Sample Pool2 (653.8 nmol/L): SD 14.88-21.51, %CV 2.28-3.25 across 3 lots.
- Sample Pool4 (1001.2-1026.3 nmol/L): SD 20.34-22.95, %CV 2.02-2.24 across 3 lots.
- Sample Pool3 (1065.9-1081.6 nmol/L): SD 20.92-23.16, %CV 1.96-2.14 across 3 lots.
- Sample Pool1 (1098.0-1117.0 nmol/L): SD 16.95-24.04, %CV 1.54-2.18 across 3 lots.
- Sample Pool5 (1424.9-1474.5 nmol/L): SD 23.41-24.28, %CV 1.59-1.70 across 3 lots.
- Sample Pool6 (2857.3-2909.5 nmol/L): SD 28.61-35.76, %CV 0.99-1.25 across 3 lots.
- Within-laboratory precision:
- Sample Pool2: SD 29.16-36.26, %CV 4.46-5.38.
- Sample Pool4: SD 31.72-40.14, %CV 3.09-4.01.
- Sample Pool3: SD 32.28-38.22, %CV 3.03-3.53.
- Sample Pool1: SD 33.37-40.39, %CV 3.04-3.65.
- Sample Pool5: SD 37.17-45.41, %CV 2.61-3.14.
- Sample Pool6: SD 104.63-116.15, %CV 3.60-4.07.
- Repeatability (Within-run precision):
Method comparison:
- Study Sample: 102 samples from volunteers.
- Study Design: Comparison against a comparative method distributed over three different sites.
- Key Results:
- Passing-Bablok regression slopes: 1.12, 0.99, 1.06 (combined 1.07), deviating less than 15% from 1.0.
- Estimated mean relative bias:
- Overall: -1.04%
- Different sites: -2.14%, -0.99%, and 0.01%.
- Pearson's r correlation coefficient: 0.955.
Limit of quantification (LoQ):
- Study Sample: 20 replicates from 4 different serum pools of low concentration.
- Study Design: Measured within 3 days on a single instrument with three lots of reagents.
- Key Result: 139.7 nmol/L (lowest concentration meeting total CV of
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2023
numares AG Stefanie Dukorn Head of Quality and Regulatory Affairs Am BioPark 9 D-93053 Regensburg Germany
Re: K210801
Trade/Device Name: AXINON® LDL-p Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, subject to limitations of exemptions per 21 CFR 862.9(c)(4) Product Code: MRR Dated: November 18 2022 Received: November 18, 2022
Dear Stefanie Dukorn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Paula V. Caposino -2
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210801
Device Name AXINON® LDL-p Test System
Indications for Use (Describe)
The AXINON® LDL-o Test System is intended to measure lipoprotein particles to quantify LDLp) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values 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 system is for professional use only.
| 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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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K210801.
| 807.92 (a)(1): | Name: | numares AG |
|---|---|---|
| Address: | Am BioPark 9, 93053 Regensburg, Germany | |
| Phone: | +49 941 280 949-00 | |
| Email: | info@numares.com | |
| Contact: | Dr. Stefanie Dukorn, direct line +49 941 280 949-22, email stefanie.dukorn@numares.com |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name: AXINON® LDL-p Test System
Common Name: AXINON® LDL-p Test System
Classification Names:
Lipoprotein test system, 21 CFR 862.1475, Product Code MRR
807.92 (a)(3): Identification of the legally marketed predicate devices
The AXINON® LDL-p Test System is substantially equivalent to the NMR Lipoprofile Assay (K063841).
807.92 (a)(4): Device Description
The AXINON® LDL-p Test System involves measurement of the 600 MHz proton NMR spectrum of a serum sample, deconvolution of the composite signal at approximately 0.85 ppm to produce signal amplitudes of lipoprotein subclass proportions that contribute to the composite serum signal, and conversion of these subclass signal amplitudes to lipoprotein subclass concentrations. The 0.85 ppm serum NMR signal arises mainly from the methyl group protons of the lipids carried in the VLDL, LDL and HDL subclasses of varying diameters. The NMR signals from the various lipids within the lipoprotein subclasses have unique and distinctive shapes and frequencies, uncovered by the granular decomposition of the composite serum signal. Each of these lipid signal representatives 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).
4
The AXINON® LDL-p Test System including the AXINON® Analyzer is a clinical laboratory analyzer that employs nuclear magnetic resonance spectroscopic detection to quantify multiple analytes in biological fluid specimens, specifically human serum.
The AXINON® Analyzer system is distributed across two separate computers:
The workstation running AXINON® Software is the main host of the system. It controls user interfaces, data handling, results calculation, schedules and manages all activities required to process a sample, and manages remote access to the NMR system.
In addition, AXINON® Analyzer comes with the optional software utility AXINON® Sample Wizard that supports manual sample preparation procedures.
The NMR workstation controls all magnet operations and the hardware in the sample handler.
807.92 (a)(5): Intended Use
The AXINON® LDL-p Test System is intended to measure lipoprotein particles to quantify LDL particle number (LDL-p) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values 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 system is for professional use only.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
The AXINON® LDL-p Test System is as safe and effective as the predicate device, K063841. The minor technological differences between the AXINON® LDL-p Test System and the predicate device (spectrometer frequency) raise no new issues of safety or effectiveness. The restriction of AXINON® LDL-p to a single output parameter (without HD-C and Triglycerides) does not raise new issues of safety of effectiveness, as these are readily available in routine diagnostic and all results are used in conjunction with other lipid measurements and clinical evaluation.
5
Comparison with predicate
| | Predicate NMR Lipoprofile-2
Assay and NMR Profiler Test
System | Proposed AXINON® LDL-p Test
System |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K063841 | K210801 |
| Intended Use /
Indications for
Use | The NMR LipoProfile® -2 test, used
with the NMR Profiler, an automated
NMR spectrometer, measures
lipoprotein particles to quantify LDL
particle number (LDL-P), HDL
cholesterol (HDL-C), and
triglycerides in serum and plasma
using nuclear magnetic resonance
(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. | The AXINON® LDL-p Test
System is intended to measure
lipoprotein particles to quantify
LDL particle number (LDL-p)
using nuclear magnetic resonance
(NMR) spectroscopy that
measures the 600 MHz proton
nuclear magnetic resonance
(NMR) spectrum of a human
serum sample. LDL-p
concentration values 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
system is for professional use
only. |
| Technology | Nuclear magnetic resonance | Same |
| Multi- analyte | No | Same |
| Detection Method | 400 MHz proton NMR spectrum | 600 MHz proton NMR spectrum |
| Data Acquisition
Software | Possess data acquisition software and
software to process detected signals | Same |
| Patient
Population | General | Same |
| Instrument
Platform | NMR profiler | AXINON® Analyzer |
| Specimen | Human serum and plasma | Human serum |
| Analyzer | 400 MHz NMR Spectrometer | 600 MHz NMR Spectrometer |
| Spectral
Deconvolution
Computational
Processes | Linear least-squares with singular
value decomposition of the spectra
from each specimen | Similar |
| Reference Range | Distribution of LDL-p observed in a
general apparently healthy population
of men and women | Same |
We performed analytical validations to demonstrate that the AXINON® LDL-p test system is equivalent to the NMR LipoProfile® test on the Vantera Clinical Analyzer. The comparative analytical performance is shown in tables below.
6
| | LDL-p
Detection
capability | AXINON® LDL-p Test System | Predicate Device | | | | | | | |
|------|--------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|--------|--------|------|-----------------------------------------------|--|
| | LoB | 0 nmol/L | n.d. | | | | | | | |
| | LoD | 99 nmol/L | n.d. | | | | | | | |
| | LoQ | 139.7 nmol/L | 300 nmol/L | | | | | | | |
| | Measuring
range | 300 - 3100 nmol/L | 300 - 3500 nmol/L | | | | | | | |
| | Linearity
regression | y = 1.05x - 28.33 | n.d. | | | | | | | |
| | Linearity R2 | 0.998 | n.d. | | | | | | | |
| | Within-run
precision
(Repeatability) | LV 1 | LV 2 | LV 3 | LV 4 | LV 5 | LV 6 | LV 1 | LV 2 | |
| Mean | Lot1 | 653.8 | 1006.8 | 1069.0 | 1098.0 | 1424.9 | 2857.3 | | | |
| | Lot2 | 674.2 | 1026.3 | 1081.6 | 1117.0 | 1474.5 | 2909.5 | 2222 | 1042 | |
| | Lot3 | 656.2 | 1001.2 | 1065.9 | 1105.2 | 1447.8 | 2875.4 | | | |
| SD | Lot1 | 14.88 | 20.34 | 22.54 | 16.95 | 24.28 | 35.76 | | | |
| | Lot2 | 21.51 | 22.95 | 23.16 | 22.07 | 23.41 | 33.02 | 49,1 | 47.7 | |
| | Lot3 | 21.33 | 21.25 | 20.92 | 24.04 | 23.93 | 28.61 | | | |
| CV % | Lot1 | 2.28 | 2.02 | 2.11 | 1.54 | 1.70 | 1.25 | | | |
| | Lot2 | 3.19 | 2.24 | 2.14 | 1.98 | 1.59 | 1.13 | 2.2% | 4.6% | |
| | Lot3 | 3.25 | 2.12 | 1.96 | 2.18 | 1.65 | 0.99 | | | |
| | Within-lab
Precision | LV 1 | LV 2 | LV 3 | LV 4 | LV 5 | LV 6 | LV 1 | LV 2 | |
| Mean | Lot1 | 653.8 | 1006.8 | 1069.0 | 1098.0 | 1424.9 | 2857.3 | | | |
| | Lot2 | 674.2 | 1026.3 | 1081.6 | 1117.0 | 1474.5 | 2909.5 | 1925 | 1053 | |
| | Lot3 | 656.2 | 1001.2 | 1065.9 | 1105.2 | 1447.8 | 2875.4 | | | |
| SD | Lot1 | 29.16 | 32.93 | 36.75 | 33.37 | 37.17 | 116.15 | | | |
| | Lot2 | 36.26 | 31.72 | 38.22 | 34.22 | 39.67 | 104.63 | 66.7 | 68.4 | |
| | Lot3 | 34.22 | 40.14 | 32.28 | 40.39 | 45.41 | 112.62 | | | |
| CV% | Lot1 | 4.46 | 3.27 | 3.44 | 3.04 | 2.61 | 4.07 | | | |
| | Lot2 | 5.38 | 3.09 | 3.53 | 3.06 | 2.69 | 3.60 | 3.5% | 6.5% | |
| | Lot3 | 5.22 | 4.01 | 3.03 | 3.65 | 3.14 | 3.92 | | | |
| | Method
comparison | | Linear regression
y = 1.07x -90.16, R=0.955 | clinical | | | | | | |
| | Interference
study | | 10 Endogenous and 26 Exogenous were tested.
Naproxen (sodium salt) at above 0.55 mmol/L
may cause falsely low results.
1-propanol at concentrations above 1 mmol/L
may cause missing or falsely low results. | | | | | | 5 Endogenous and 20
Exogenous were tested. | |
| | Specimen
stability | | Prepared serum:
Refrigerated Stability 5 days | | | | | | NMR Lipotube: freshly
draw serum | |
807.92 (b)(1): Brief Description of Nonclinical Data
7
Linearity: For LDL-p, the measurement procedure shows linearity for the interval from 300 to 3100 nmol/L, with deviations from linearity within ± 10% for the range from 800 nmol/L to 3100 nmol/L and within ± 80 nmol/L for the range from 300 nmol/L to 800 nmol/L. In a study with 11 levels and five replicates for each level, the maximum observed % deviation from linearity was 23.2% (at 219 nmol/L) and the maximum observed absolute deviation was 126.7 nmol/L (at 3285 nmol/L).
Precision: within-run imprecision and within-lab precision were determined at six concentration levels, measured in duplicates in two runs each day over a period of 20 days with three lots of reagents.
| Sample ID
(Description) | lot | Mean
Value | N | Repeatability | | Between-
Run | | Between-Day | | Within-
Laboratory | |
|------------------------------------------|-----|---------------|----|---------------|------|-----------------|------|-------------|------|-----------------------|------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Pool2
(pooled
patient
samples) | 1 | 653.8 | 80 | 14.88 | 2.28 | 25.07 | 3.83 | 0 | 0 | 29.16 | 4.46 |
| | 2 | 674.2 | 80 | 21.51 | 3.19 | 29.19 | 4.33 | 0 | 0 | 36.26 | 5.38 |
| | 3 | 656.2 | 80 | 21.33 | 3.25 | 26.76 | 4.08 | 0 | 0 | 34.22 | 5.22 |
| Pool 4
(pooled
patient
samples) | 1 | 1006.8 | 80 | 20.34 | 2.02 | 22.35 | 2.22 | 13.09 | 1.30 | 32.93 | 3.27 |
| | 2 | 1026.3 | 80 | 22.95 | 2.24 | 9.63 | 0.94 | 19.67 | 1.92 | 31.72 | 3.09 |
| | 3 | 1001.2 | 80 | 21.25 | 2.12 | 32.20 | 3.21 | 11.06 | 1.10 | 40.14 | 4.01 |
| Pool 3
(pooled
patient
samples) | 1 | 1069.0 | 80 | 22.54 | 2.11 | 25.71 | 2.41 | 13.47 | 1.26 | 36.75 | 3.44 |
| | 2 | 1081.6 | 80 | 23.16 | 2.14 | 21.72 | 2.01 | 21.28 | 1.97 | 38.22 | 3.53 |
| | 3 | 1065.9 | 80 | 20.92 | 1.96 | 20.84 | 1.95 | 13.05 | 1.22 | 32.28 | 3.03 |
| Pool 1
(pooled
patient
samples) | 1 | 1098.0 | 80 | 16.95 | 1.54 | 23.98 | 2.18 | 15.85 | 1.44 | 33.37 | 3.04 |
| | 2 | 1117.0 | 80 | 22.07 | 1.98 | 16.70 | 1.50 | 20.13 | 1.80 | 34.22 | 3.06 |
| | 3 | 1105.2 | 80 | 24.04 | 2.18 | 23.42 | 2.12 | 22.47 | 2.03 | 40.39 | 3.65 |
| Pool 5
(pooled
patient
samples) | 1 | 1424.9 | 80 | 24.28 | 1.70 | 22.35 | 1.57 | 17.12 | 1.20 | 37.17 | 2.61 |
| | 2 | 1474.5 | 80 | 23.41 | 1.59 | 24.86 | 1.69 | 20.19 | 1.37 | 39.67 | 2.69 |
| | 3 | 1447.8 | 80 | 23.93 | 1.65 | 25.72 | 1.78 | 28.78 | 1.99 | 45.41 | 3.14 |
| Pool 6
(commercial
control) | 1 | 2857.3 | 80 | 35.76 | 1.25 | 33.29 | 1.17 | 105.38 | 3.69 | 116.15 | 4.07 |
| | 2 | 2909.5 | 80 | 33.02 | 1.13 | 47.33 | 1.63 | 87.28 | 3.00 | 104.63 | 3.60 |
| | 3 | 2875.4 | 80 | 28.61 | 0.99 | 55.11 | 1.92 | 93.96 | 3.27 | 112.62 | 3.92 |
Method comparison: The experiment was performed on 102 samples from volunteers against the comparative method distributed over three different sites. Passing-Bablok regression slopes were found to deviate less than 15% from 1.0 for all sites (1.12, 0.99, 1.06; combined 1.07). The estimated mean relative bias with respect to the comparative method was found to be -1.04% overall and -2.14%. -0.99% and 0.01% for the different sites, respectively. The estimated mean relative bias therefore lies well within the (optional) acceptance criterion of