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ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, sodium azide.

ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Sizes:
  • Precision (Serum/Plasma and Urine): 80 measurements per level (3 levels for each matrix).
  • Method Comparison (Serum/Plasma): 100 patient serum samples.
  • Method Comparison (Urine): 54 patient urine samples.
  • Matrix Comparison (Plasma): 43 patient plasma samples (lithium heparin).
  • Detection Limit (Serum/Plasma and Urine): 15 measurements of 4 samples for LoD and LoQ for each matrix.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. However, the studies were conducted by ELITech Clinical Systems SAS, which is located in France, suggesting the data may originate from a European setting. The methodology described (e.g., patient sample testing, specific protocols) implies these were prospective studies where samples were collected and tested as part of the validation process.

3. Number of Experts and Qualifications for Ground Truth:

The document describes performance studies for an in-vitro diagnostic (IVD) reagent for creatinine measurement. For such devices, "ground truth" is typically established by reference methods or validated comparative methods.

• No human experts were used to establish ground truth for the test values of the samples in the analytical performance studies (precision, linearity, detection limit, interference). These are determined by the measurements themselves and compared against established analytical criteria and industry standards.
• For Traceability, ELITech Clinical Systems ELICAL 2 calibrator values are traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method. This is considered the "gold standard" for accuracy in many clinical chemistry analytes and represents the highest level of ground truth for calibration.
• For Method Comparison, the "ground truth" for the comparative study was the results obtained from the predicate device, the Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer. The predicate device itself has undergone its own validation and regulatory clearance processes.

4. Adjudication Method:

• None. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images generates the ground truth, and discrepancies between readers need to be resolved. This document describes an IVD device for quantitative chemical analysis, where measurements are objective and do not involve human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC comparative effectiveness study was not done. These studies are relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists interpreting images). This device is an in-vitro diagnostic reagent and does not involve human readers in the diagnostic process beyond performing the test and interpreting the quantitative result.

6. Standalone (Algorithm Only) Performance:

• Yes, effectively. The performance described (precision, linearity, detection limits, interference, method comparison) represents the standalone performance of the ELITech Clinical Systems CREATININE PAP SL reagent as performed on the ELITech Clinical Systems Selectra Pro Series Analyzers, without human interpretation as part of the measurement process itself. The "algorithm" here is the enzymatic colorimetric assay methodology of the reagent combined with the automated analyzer.

7. Type of Ground Truth Used:

• Primarily Expert Concensus (ID-MS Traceability) and Comparative Method (Predicate Device):
  • For calibration and absolute accuracy, the calibrator (ELICAL 2) is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method, which is a highly accurate, consensus-driven method used by reference laboratories to establish true values.
  • For method comparison, the ground truth was established by the predicate device (Roche Diagnostics CREP2 on a cobas c111 analyzer). The performance of the new device was compared against this already legally marketed and validated method.
  • For analytical performance characteristics like precision, linearity, detection limits, and interference, the "ground truth" is defined by adherence to established analytical protocols (CLSI guidelines) and the reproducibility/accuracy of the measurements themselves in controlled conditions.

8. Sample Size for the Training Set:

• Not explicitly stated/Not applicable in the traditional sense. This is an in-vitro diagnostic reagent, not an AI/machine learning model that typically involves a "training set" in the computational sense.
• However, the development of such reagents involves extensive research and development, including formulation, optimization, and preliminary testing, which could be considered an analogous "training" phase to refine the product. The document highlights the use of CLSI standard protocols for performance evaluation, which are used to test the final product, not to "train" it.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable in the traditional AI/ML sense. For an IVD reagent, the "ground truth" during its development (analogous to training) would involve:
  • Chemical principle validation: Ensuring the enzymatic reaction effectively measures creatinine.
  • Formulation optimization: Through numerous experiments, determining optimal concentrations of reagents for sensitivity, specificity, and stability.
  • Calibration standards: Developing and validating calibrators against recognized reference materials (like ID-MS) to ensure accurate quantification across the measuring range.
  • This iterative process relies on established chemical principles, analytical instrumentation, and validation against known standards and samples with established values, often aligned with international reference methods.

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ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (

This document describes two devices, a calibrator and a control, for urine total protein measurements. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and expert reviews. Therefore, much of the requested information regarding study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.

Here's an attempt to answer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) with specific numerical targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through a comparison of intended use, format, levels, traceability, and stability. The reported "performance" is the equivalence itself.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical or analytical study with a defined sample size for the purpose of primary performance evaluation. The information provided is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to existing legally marketed devices. This typically involves analytical performance data generated by the manufacturer to support the claims, but the specific details of sample sizes for such internal validation studies are not usually included in the public 510(k) summary.

Thus, there is no explicit mention of:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of information is generally relevant for AI/CADe devices where expert consensus or pathological diagnosis establishes ground truth for image interpretation. For a calibrator and a quality control material like these, "ground truth" refers to the accurately assigned values determined through a rigorous measurement process (e.g., gravimetric methods, certified reference materials, reference methods). This is typically established by the manufacturer's internal processes and is overseen by qualified analytical chemists or scientists, not by "experts" in the clinical interpretation sense.

4. Adjudication method for the test set

Not applicable. As there is no "test set" with expert interpretations being adjudicated, this information is not relevant to the provided documentation.

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. MRMC studies are specific to AI/CADe devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The devices described here (calibrator and control) are in vitro diagnostic reagents and do not involve human interpretation in the same way.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. These are chemical reagents, not algorithms.

7. The type of ground truth used

For the Calibrator: The calibrator is stated to be traceable to SRM 927d (Standard Reference Material 927d). This likely refers to a National Institute of Standards and Technology (NIST) SRM for total protein, which would be the reference method or certified reference material providing the "ground truth" for the calibrator's assigned value.

For the Control: The control is intended for quality control of quantitative methods. The "ground truth" for control materials is typically established by assigned values determined by the manufacturer using validated methods, often relative to reference materials or established laboratory methods. The document also mentions that each urine donation for the control material is "tested individually and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods," which contributes to the safety and quality control of the control material itself, rather than establishing a quantitative "ground truth" for a specific analyte measurement.

8. The sample size for the training set

Not applicable. These are not AI/machine learning devices that require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for these types of devices.

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