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510(k) Data Aggregation
(35 days)
MRR
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(854 days)
MRR
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.
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.
Here's a breakdown of the acceptance criteria and study information for the AXINON® LDL-p Test System, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (AXINON® LDL-p Test System) | Predicate Device (NMR Lipoprofile® Assay) |
|---|---|---|
| Detection Capability | ||
| Limit of Blank (LoB) | 0 nmol/L | n.d. |
| Limit of Detection (LoD) | 99 nmol/L | n.d. |
| Limit of Quantitation (LoQ) | 139.7 nmol/L (total CV |
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(273 days)
MRR
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
Device Name: Direct LDL Cholesterol (LDL)
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Precision | Total CV % (within run, among run, among day) | Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels. | QC 1 (92.0 mg/dl): 5.9% total CV |
| QC 2 (135.9 mg/dl): 4.6% total CV | |||
| QC 3 (186.7 mg/dl): 4.4% total CV | |||
| Serum pool 1 (65.0 mg/dl): 5.9% total CV | |||
| Serum pool 2 (154.0 mg/dl): 5.0% total CV | |||
| Serum pool 3 (200.1 mg/dl): 5.0% total CV | |||
| Serum pool 4 (343.7 mg/dl): 5.3% total CV | |||
| Linearity/Reportable Range | Linear Regression Correlation Coefficient (r) | Close to 1.0 (indicating a strong linear relationship) | r = 0.997 |
| Reportable Range | Defined range where results are linear. | 21 - 740 mg/dl | |
| Detection Limit | Limit of Blank (LoB) | Very low, ideally close to zero, to ensure no signal from blank. | 1.94 mg/dl |
| Limit of Detection (LoD) | Low enough to reliably detect the analyte. | 3.19 mg/dl | |
| Limit of Quantitation (LoQ) | Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision). | 16.1 mg/dl (with ≤20% imprecision) | |
| Analytical Specificity | Interference (% of Control) | % of Control ± 10% for potential interferents at specified concentrations. | Hemoglobin: No significant interference up to 1000mg/dl. |
| Total Bilirubin: No significant interference up to 60mg/dl. | |||
| Conjugate Bilirubin: No significant interference up to 60mg/dl. | |||
| Triglycerides: No significant interference up to 500mg/dl. | |||
| Intralipid®: No significant interference up to 500mg/dl. | |||
| Ascorbic Acid: No significant interference up to 6mg/dl. | |||
| Method Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when compared to a predicate device, indicating substantial equivalence. | r = 0.998 (compared to predicate device) |
| Matrix Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices. | r = 0.998 (serum vs. lithium heparin plasma) |
| Traceability | Conformance to reference materials/standards | Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling). | Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN." |
Study Details
- Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g.,
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(89 days)
MRR
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance (S-Test LDL reagent with S40 Clinical Analyzer) |
|---|---|---|
| Precision | Not explicitly stated, but generally indicative of good clinical practice for quantitative assays. | Within-run CV: 1.2 to 2.2% (at three LDL levels over 22 days); 0.8 to 2.8% (at three POL sites over 5 days) |
| Total CV: 2.2 to 2.5% (at three LDL levels over 22 days); 1.2 to 2.8% (at three POL sites over 5 days) | ||
| Accuracy (Correlation to Comparative Method) | Not explicitly stated, but generally high correlation (e.g., R-value > 0.95) with acceptable bias and confidence intervals for slopes and intercepts are expected. | Correlation Coefficient: 0.996 (for 110 serum samples, 11-388 mg/dL) |
| Standard Error Estimate: 6.6 | ||
| Confidence Interval Slope: 0.948 to 0.982 | ||
| Confidence Interval Intercept: -1.7 to 3.4 | ||
| POL Site Correlations: 0.995 to 0.997 (correlation coefficients); 6.0 to 8.0 (standard error estimates); 0.895 to 0.967 (confidence interval slopes); -4.6 to 13.6 (confidence interval intercepts) | ||
| Sensitivity (Detection Limit) | Not explicitly stated, but a low detection limit is desirable for clinical utility, especially for lower values. | 1 mg/dL |
| Matrix Comparison (Serum vs. Plasma) | Not explicitly stated, but no statistically significant difference between serum and heparin plasma measurements is expected to demonstrate interchangeable use. | t-Statistic: 1.71 (for 34 paired samples, 13-350 mg/dL) |
| t-Critical Value: 2.03 at α = 0.05 | ||
| Conclusion: Not statistically significant difference between serum and plasma, confirming use of plasma. |
2. Sample Size and Data Provenance for the Test Set:
- Precision Studies:
- Main Study: Not explicitly stated, but "three LDL levels for 22 days" implies repeated measurements over time. The number of individual samples for within-run and total CV calculation would be based on these repeated measurements at each level.
- POL Site Studies: "three separate Physician Office Laboratory (POL) sites over 5 days" at "three separate POL sites." Similar to the main study, number of individual samples would be based on repeated measurements at each POL site.
- Accuracy (Correlation Study): 110 serum samples with LDL values ranging from 11 to 388 mg/dL.
- Matrix Comparison (Serum vs. Plasma): 34 paired samples drawn from the same patients.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the submission is to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective in nature, as they involve performing tests on samples to evaluate device performance.
3. Number of Experts and Qualifications for Ground Truth:
The document describes performance studies comparing the S-Test LDL reagent to a "comparative method" or a "predicate device" (Alfa Wassermann ACE plus ISE/Clinical Chemistry System with ACE Low Density Lipoprotein Cholesterol Reagent K991733).
- Number of Experts: Not applicable. The ground truth for this type of IVD device is typically established by another established, validated reference method or device, rather than by human expert consensus or interpretation of images.
- Qualifications of Experts: Not applicable. The "ground truth" is analytical results from an established comparative method or predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The reported studies are analytical performance studies for an in vitro diagnostic (IVD) device, not studies involving human interpretation or adjudication. The "adjudication" is essentially the direct comparison of quantitative results between the candidate device and a comparative method using statistical analysis (e.g., least-squares regression, t-test).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images). The S-Test LDL Cholesterol Reagent is an automated in vitro diagnostic assay that provides a quantitative numerical result, not an image or output requiring human interpretation in the context of a "reader."
6. Standalone (Algorithm Only) Performance:
Yes, the studies described are standalone performance studies of the S-Test LDL Reagent used with the S40 Clinical Analyzer. The purpose is to demonstrate the analytical performance of the device itself (reagent and analyzer system) without human diagnostic interpretation being a variable in the performance assessment.
7. Type of Ground Truth Used:
The ground truth used was analytical measurements obtained from a comparative method or predicate device. This is a common approach for establishing the accuracy of new in vitro diagnostic assays by correlating their results with those of an already accepted and validated method.
8. Sample Size for the Training Set:
The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a traditional in vitro diagnostic reagent and analyzer system, not an AI-powered device that requires training data. The studies described are for analytical validation.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or AI model development in the provided text.
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(120 days)
MRR
The EasyRA dLDL reagent is intended for the quantitative determination of Low Density Lipoproteins in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The EasyRA dLDL calibrator facilitates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent. The dLDL calibrator is used to establish a point of reference that is used in the determination of values in the measurement of LDL Cholesterol in human serum.
The EasyRA EasyQC material validates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent and calibrator. The EasyQC is used to estimate test precision and to detect systemic analytical deviations that may arise from reagent or analytical instrument variation.
Not Found
This document is a 510(k) premarket notification from the FDA for a medical device called "EasyRA Direct Low Density Lipoproteins Cholesterol Reagent." It specifies the device's indications for use and mentions associated calibrators and quality control materials. However, it does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval (substantial equivalence) and product labeling, not on the performance study details themselves.
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(575 days)
MRR
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 NMR LipoProfile Test involves measurement of the 400 MHz proton NMR spectrum of a plasma or serum sample, deconvolution of the composite signal at ~0.8 ppm to produce the signal amplitudes of the lipoprotein subclasses that contribute to the composite plasma 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 VLDL, and HDL subclasses of varying diameter. The NMR signals from the various lipoprotein subclasses have unique and distinctive frequencies and lineshapes, each of which are 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 that assume that the various lipoprotein subclass particles have cholesterol and triglyceride contents characteristic of normolipidemic individuals, HDL cholesterol and triglyceride concentrations are also derived.
AI Device Acceptance Criteria and Study Summary
Here's an analysis of the provided text regarding the NMR LipoProfile-2 Assay and NMR Profiler Instrument Test System:
1. Acceptance Criteria and Reported Device Performance
The document describes several analytical and clinical performance aspects. While explicit "acceptance criteria" for all metrics are not always stated with numerical thresholds, they are implied through the performance data and comparisons to predicate devices. For analytical sensitivity and linearity, specific ranges are provided.
Table 1: Acceptance Criteria (Implied/Stated) and Reported Device Performance
| Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity: | Acceptable precision and accuracy with total error ≤20%. | |
| - LDL-P (LOQ) | - | 300 nmol/L |
| - HDL-C (LOQ) | - | 10 mg/dL |
| - Triglycerides (LOQ) | - | 25 mg/dL |
| Assay Precision: | Acceptable intra-assay and inter-assay variability. (No explicit numeric criteria stated, but low CVs are implied as acceptable) | |
| - LDL-P (Intra-assay) | Pool 1: Mean 2222 nmol/L, SD 49.1, %CV 2.2; Pool 2: Mean 1042 nmol/L, SD 47.7, %CV 4.6 | |
| - LDL-P (Inter-assay) | Pool 1: Mean 1925 nmol/L, SD 66.7, %CV 3.5; Pool 2: Mean 1053 nmol/L, SD 68.4, %CV 6.5 | |
| - HDL-C (Intra-assay) | Pool 1: Mean 41 mg/dL, SD 0.54, %CV 1.3; Pool 2: Mean 57 mg/dL, SD 0.42, %CV 0.7 | |
| - HDL-C (Inter-assay) | Pool 1: Mean 42 mg/dL, SD 1.17, %CV 2.8; Pool 2: Mean 56 mg/dL, SD 0.83, %CV 1.5 | |
| - Trig (Intra-assay) | Pool 1: Mean 189 mg/dL, SD 2.0, %CV 1.1; Pool 2: Mean 75 mg/dL, SD 1.2, %CV 1.5 | |
| - Trig (Inter-assay) | Pool 1: Mean 219 mg/dL, SD 2.9, %CV 1.3; Pool 2: Mean 80 mg/dL, SD 1.7, %CV 2.1 | |
| Linearity: | Wide varying target concentrations with acceptable percent bias. | |
| - LDL-P (Linear Range) | - | 300-6000 nmol/L |
| - HDL-C (Linear Range) | - | 7-160 mg/dL |
| - Triglycerides (Linear Range) | - | 5-2700 mg/dL |
| Reportable Range: | - | |
| - LDL-P | - | 300 - 3500 nmol/L |
| - HDL-C | - | 7 - 140 mg/dL |
| - Triglycerides | - | 5 - 1100 mg/dL |
| Interfering Substances: | No appreciable interference at clinically relevant concentrations. | No appreciable interference by Endogenous substances (Bilirubin, Creatinine, Hemoglobin, Urea, Uric acid) or Exogenous substances (Acetaminophen, Aspirin, Clopidogrel, Enalapril, Fenofibrate, Furosemide, Glipizide, Hydralazine, Hydrochlorothiazide, Ibuprofen, Isosorbide dinitrate, Metformin, Metoprolol, Naproxen, Niacin, Nifedipine, Piroxicam, Simvastatin, Thiazolidinedione, Triamterene) at tested concentrations. The concentrations tested were representative of the highest blood concentrations expected for the highest therapeutic doses of these compounds. |
| Method Comparison (HDL-C): | Demonstrate substantial equivalence to a predicate chemistry analyzer system. (Implicit: strong correlation and similar mean values.) | 5,362 plasma samples tested. R-squared = 0.897. NMR LipoProfile mean: 50.7 mg/dL; Predicate mean: 51.3 mg/dL. |
| Method Comparison (Triglycerides): | Demonstrate substantial equivalence to a predicate chemistry analyzer system. (Implicit: strong correlation and similar mean values.) | 5,362 plasma samples tested. R-squared = 0.929. NMR LipoProfile mean: 128.7 mg/dL; Predicate mean: 123.9 mg/dL. |
| Clinical Performance (LDL-P): | Statistically significant relationship to CVD risk, aiding in the management of lipoprotein disorders. (Implicit: demonstrating predictive value for cardiovascular events). | VA-HIT Study (Baseline): Odds Ratio 1.31 (95% CI, 1.09-1.57), p=0.004 for a new CHD event with 1-SD increment of LDL-P in placebo group. EPIC-Norfolk Study (Multivariable): Statistically significant association of LDL-P quartiles with incident CAD events (p=0.02, highest quartile HR 1.37 (1.04-1.83)). Women's Health Study: Statistically significant association of LDL-P quintiles with incident CVD events (p |
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(98 days)
MRR
For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Not Found
The provided FDA document is a 510(k) premarket notification for a "Direct LDL Cholesterol Reagent." This is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the concepts of acceptance criteria met by an algorithm, training and test sets, expert ground truth, MRMC studies, or standalone performance do not apply in the context of this document.
The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means its performance is considered comparable to existing, legally marketed devices.
The "Indications for Use" section specifies that the device is "For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma."
To adequately respond to your request for AI/ML device-specific information, I would need a document pertaining to an AI/ML medical device.
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(63 days)
MRR
The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.
The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.
The provided text describes the 510(k) summary for the "LDL-EX SEIKEN Assay Kit." Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Predicate Device | r = 0.994 |
| - Slope | 0.982 |
| - Y-intercept | -1.83 |
| Precision (Within-run and Between-day CVs) | Very similar to the predicate device's kit insert. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 100 donor samples
- Data Provenance: The document does not specify the country of origin for the donor samples or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the ground truth was established by comparison with a legally marketed predicate device, not through expert consensus on diagnostic images or pathology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The study involved direct comparison of quantitative results between the new device and a predicate device, not human review and adjudication of findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was done for the device, where its measurements were directly compared against a predicate device. The device itself (the "LDL-EX SEIKEN Assay Kit") is an automated assay, meaning it operates without human intervention once the sample is loaded.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established by comparison to a legally marketed predicate device (N-Geneous LDL Cholesterol Reagent [Genzyme Corp.]). The assumption is that the predicate device provides accurate measurements of LDL-C, thereby serving as the "ground truth" for the new device's performance evaluation.
8. The sample size for the training set
This information is not applicable. This device is a chemical assay kit, not a machine learning or AI model, thus it does not have a "training set" in the conventional sense. Its performance is characterized through direct comparison and precision studies.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this type of device.
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(127 days)
MRR
For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Not Found
The provided text is an FDA 510(k) clearance letter for the "LDL-ADVANCE Assay, Cat. No. 279-20, 279-40". This document is a regulatory approval and does not contain the detailed study information or acceptance criteria typical for a device performance evaluation. It primarily states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.
Specifically, the document states:
- Device Name: LDL-ADVANCE Assay, Cat. No. 279-20, 279-40
- Indications for Use: "For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases."
Without a separate clinical or performance study report, it's impossible to answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.
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MRR
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The provided text describes the acceptance criteria and study for the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. However, it is a 510(k) summary for an in vitro diagnostic device (IVD), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo clinical studies often associated with AI/ML devices or complex medical devices. Therefore, some of the information requested, especially regarding AI/ML-specific metrics like MRMC studies, sample sizes for AI training sets, ground truth establishment for training, and expert qualifications/adjudication for test sets, is not applicable or not present in this type of document.
Here's the available information extracted and organized according to your prompt:
1. Table of acceptance criteria and the reported device performance
For the VITROS dLDL Reagent (new device) compared to the Polymedco Lipi+Plus Direct LDL assay (predicate device):
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (VITROS dLDL) |
|---|---|---|
| Correlation with Predicate | Strong linear correlation and high correlation coefficient | VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908 |
| Reportable Range | Consistent with predicate's intended use | 30 - 350 mg/dL |
| Specimen Pretreatment | None Required (Homogeneous assay) | None Required (Homogeneous assay) |
| Basic Principle | Elimination enzymatic test | Elimination enzymatic test |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | (Not an acceptance criterion for the reagent itself, but specified as the intended platform) | VITROS 5,1 FS Chemistry System |
| Sample Type | Serum and Plasma | Serum and Plasma (heparin) |
| Reaction Steps | Step 1: Elimination, Step 2: Measurement | Step 1: Elimination, Step 2: Measurement |
| Incubation Temperature | 37 °C | 37 °C |
| Additional Studies (Summarized) | Acceptable precision, specificity, linearity, and expected values | Studies performed to determine precision, specificity, linearity, and expected values (results summarized in Instructions for Use, not detailed here) |
For the VITROS Chemistry Products Performance Verifiers I and II (new device) compared to the VITROS Chemistry Products Performance Verifiers (predicate device):
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (VITROS dLDL) |
|---|---|---|
| Intended Use | Monitor performance on VITROS Chemistry Systems | Monitor performance on VITROS Chemistry Systems (New additional intended use: to monitor performance of LDL Cholesterol on the VITROS 5,1 FS Chemistry System) - Note: The "new additional intended use" is a difference, but typically deemed acceptable if performance is still substantially equivalent. |
| Matrix of Performance Verifiers | Base matrix of freeze-dried human serum with added enzymes, electrolytes, stabilizers, preservatives, and other organic analytes | Base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. |
| Performance Verifier Levels | Low and High | Low and High |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that equivalence was demonstrated using "patient samples" but does not specify the number of samples used for the correlation study or other performance studies (precision, specificity, linearity).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is described as using "commercially available reagents along with patient samples", suggesting data from clinical laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is an IVD device measuring a biochemical analyte. The "ground truth" for the test set is established by the predicate device's measurement (Polymedco Lipi+Plus Direct LDL assay). Therefore, the concept of "experts" to establish ground truth in the sense of image interpretation or diagnostic adjudication is not applicable here. The analytical measurement of the predicate device serves as the reference.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for an IVD device measuring a biochemical analyte against a predicate assay.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in vitro diagnostic assay, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. The device measures LDL cholesterol directly and its performance is assessed analytically, independent of human interpretation or an operator-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The primary ground truth for the correlation study of the VITROS dLDL assay is the measurement obtained from the predicate device, the Polymedco Lipi+Plus Direct LDL assay, on the Dade Dimension clinical chemistry analyzer. For other performance characteristics (precision, linearity), the "ground truth" would be defined by standard laboratory reference methods or expected values.
8. The sample size for the training set
This document describes a traditional IVD. The concept of a distinct "training set" for an AI/ML algorithm is not applicable here. The reagents and assay development follow established chemical and enzymatic principles, and their performance is subsequently validated using patient samples.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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