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The Atellica® CH Creatinine_3 (Crea3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin, dipotassium EDTA, and sodium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

The Atellica CH Crea3 assay is based on the reaction of picrate with creatinine in an alkaline medium to produce a red chromophore creatinine picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration. The Atellica CH Crea3 assay is a modification of the Jaffe method, using rate blanking and intercept correction. Rate blanking is used to minimize bilirubin interference. Also, because non-specific serum/plasma protein interactions with this reagent have been found to produce a positive bias of approximately 0.3 mg/dL (26.5 µmol/L), serum/plasma measurements are automatically corrected by subtracting 0.3 mg/dL (26.5 µmol/L) from each result.

The provided text describes the performance characteristics and studies for the Atellica® CH Creatinine_3 (Crea3) assay, a new in vitro diagnostic device for quantitative determination of creatinine. It compares this new device to a predicate device, the Atellica® CH Creatinine_2 (Crea_2) assay.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The document focuses on establishing substantial equivalence for an in vitro diagnostic (IVD) test, which primarily relies on analytical performance characteristics rather than clinical outcome studies or multi-reader multi-case (MRMC) comparative effectiveness studies typically seen with imaging AI devices. Therefore, some of your requested information (like number of experts for ground truth, adjudication methods, MRMC studies, and training set details for an AI model) are not directly applicable or provided in this type of submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established through various analytical performance studies, primarily comparing it to a legally marketed predicate device (Atellica® CH Creatinine_2). The acceptance criteria are implicitly defined by the successful demonstration of equivalence or meeting pre-defined performance goals for each characteristic.

Here's a table summarizing the acceptance criteria (inferred from the "designed to have" or "determined in accordance with" statements and the reported results meeting these) and the reported device performance:

• Serum 1 (0.38 mg/dL): Repeatability SD 0.006, CV 1.6%; Within-Lab SD 0.012, CV 3.2%
• Serum 2 (0.73 mg/dL): Repeatability SD 0.023, CV 3.2%; Within-Lab SD 0.029, CV 4.0%
• Serum 3 (0.73 mg/dL): Repeatability SD 0.006, CV 0.8%; Within-Lab SD 0.019, CV 2.6%
• Serum 4 (1.18 mg/dL): Repeatability SD 0.007, CV 0.6%; Within-Lab SD 0.019, CV 1.6%
• Serum QC 1 (1.85 mg/dL): Repeatability SD 0.007, CV 0.4%; Within-Lab SD 0.024, CV 1.3%
• Serum QC 2 (6.21 mg/dL): Repeatability SD 0.011, CV 0.2%; Within-Lab SD 0.067, CV 1.1%
• Serum 5 (17.39 mg/dL): Repeatability SD 0.035, CV 0.2%; Within-Lab SD 0.189, CV 1.1%
• Serum 6 (28.54 mg/dL): Repeatability SD 0.056, CV 0.2%; Within-Lab SD 0.317, CV 1.1%
  Urine Samples (n=80 each):
• Urine 1 (56.74 mg/dL): Repeatability SD 0.102, CV 0.2%; Within-Lab SD 0.746, CV 1.3%
• Urine 2 (135.80 mg/dL): Repeatability SD 0.206, CV 0.2%; Within-Lab SD 1.601, CV 1.2%
• Urine QC 1 (195.79 mg/dL): Repeatability SD 0.253, CV 0.1%; Within-Lab SD 2.376, CV 1.2%
  (All results demonstrate low CVs, indicating good precision). |
  | Reproducibility | Determined in accordance with CLSI Document EP05-A3 (implies meeting specific statistical targets for variability components across different days, lots, and instruments). | Serum Samples (n=225 each): Overall CV (%) for reproducibility ranges from 1.0% to 5.0%.
  Urine Samples (n=225 each): Overall CV (%) for reproducibility ranges from 1.4% to 1.6%.
  (All results demonstrate good reproducibility across conditions). |
  | Assay Comparison | Serum: Correlation coefficient $\ge$ 0.950 and slope of 1.00 ± 0.05, compared to predicate (Atellica CH Creatinine 2), using Weighted Deming regression.
  Urine: Correlation coefficient $\ge$ 0.950 and slope of 0.000 ± 3.00, compared to predicate (Atellica CH Creatinine 2), using Weighted Deming regression. | Serum (n=151): Regression equation y = 1.00x - 0.04 mg/dL, correlation coefficient (r) = 1.000. Sample range 0.44 to 28.64 mg/dL.
  Urine (n=113): Regression equation y = 1.00x + 0.14 mg/dL, correlation coefficient (r) = 1.000. Sample range 12.60 to 237.06 mg/dL.
  (Both serum and urine results meet the acceptance criteria for correlation and slope). |
  | Specimen Equivalence | Determined using Weighted Deming regression (implicitly, the regression line should demonstrate equivalence, i.e., close to y=x, with high correlation coefficient). | Sodium Heparin (n=50): y = 1.00x + 0.00 mg/dL, r=0.999.
  Lithium Heparin (n=50): y = 0.99x + 0.06 mg/dL, r=0.999.
  Dipotassium EDTA (n=50): y = 0.98x + 0.04 mg/dL, r=0.998.
  (All demonstrate strong equivalence to serum reference). |
  | Interferences (HIL) | $\le$ 10% interference from hemoglobin, bilirubin, and lipemia. Bias > 10% or 0.15 mg/dL (whichever is greater for serum/plasma) is considered interference. | Reported biases for Hemoglobin (1000 mg/dL), Conjugated Bilirubin (40-45 mg/dL), Unconjugated Bilirubin (45-60 mg/dL), and Lipemia (2250-3000 mg/dL) are all within the ±10% or ±0.15 mg/dL threshold for the tested analyte concentrations, demonstrating acceptable interference profiles. |
  | Interfering Substances | Bias $\le$ 10% or ±0.15 mg/dL for Serum/plasma samples. Bias $\le$ 10% for Urine samples (for listed substances). | Most tested substances (e.g., Acetaminophen, Ascorbic Acid, etc.) show negligible bias, meeting the criteria.

Substances showing bias beyond acceptance criteria for Serum:

• Cefoxitin: Significant interference (e.g., 243.6% and 947.9% bias at high concentrations).
• Cephalothin: Shows significant bias (e.g., 44.0% bias at 180 mg/dL).
• Glucose: Shows bias beyond 10% at higher concentrations (e.g., 11.5% at 500 mg/dL and 22.5% at 1000 mg/dL).
• Total Protein: Shows bias beyond 0.15 mg/dL at 15 g/dL (0.45 mg/dL).
• Acetohexamide: Shows bias beyond 10% at 2.0 mg/dL (10.4%).
• Hydroxocobalamin (Cyanokit): Shows significant bias (e.g., 14.5% and 49.3% at higher concentrations).

Substances showing bias beyond acceptance criteria for Urine:

• Cefoxitin: Shows bias beyond 10% at higher concentrations (e.g., 11.3% and 15.4%).
  (The document explicitly lists these substances under "Interference beyond ±10% for Serum" and "Interference beyond ±10% for Urine," indicating that they failed the non-interference criteria at the tested concentrations. This is typical for IVD submissions, where known interferences are identified for labeling purposes). |
  | Standardization | The assay shall be traceable to the reference material SRM967, from the National Institute of Standards and Technology (NIST). | Statement confirms the assay is traceable to NIST SRM967. |

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Sizes:
     • Detection Capability: Not explicitly stated as "sample size" but data points obtained according to CLSI EP17-A2.
     • Precision: 80 data points per serum/urine sample type (duplicate runs for 20 days, 2 runs/day).
     • Reproducibility: 225 data points per serum/urine sample type (n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots).
     • Assay Comparison: 151 serum samples and 113 urine samples.
     • Specimen Equivalence: 50 samples for each plasma type (Sodium Heparin, Lithium Heparin, Dipotassium EDTA) compared to serum.
     • Interference (HIL & Non-Interfering Substances): Not explicitly stated as a total sample size, but experiments are designed to test specific analyte concentrations with and without interferents, following CLSI EP07-ED3.
   • Data Provenance: Not explicitly stated in terms of country of origin. Given the manufacturer (Siemens Healthcare Diagnostics Inc. in Tarrytown, New York, USA) and FDA submission, it's highly probable the studies were conducted in the US or in compliance with US regulatory standards. The studies described are retrospective in the sense that they use pre-collected or prepared samples to assess the analytical performance of the device under controlled conditions, not prospective in tracking patient outcomes in a clinical trial.

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

   • For an in vitro diagnostic (IVD) device measuring a quantitative analyte like creatinine, "ground truth" is typically established by reference methods or established laboratory standards and calibrators, not by human expert consensus or labeling of medical images.
   • The "ground truth" for creatinine concentration in this context is based on traceable reference materials (NIST SRM 967) and established laboratory measurement principles, and the performance is compared against a legally marketed predicate device.
   • Therefore, this question (relevant for AI/imaging devices) does not directly apply to this type of IVD submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically used in clinical trials or image labeling pipelines where there's human interpretation involved and a need to resolve disagreements among multiple readers; this is an analytical performance study of an IVD assay.

4. 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 is not an AI/imaging device. It's an in vitro diagnostic assay.

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

   • This is an automated IVD assay performed on the Atellica® CH Analyzer. Its intended use is quantitative determination of creatinine. Therefore, the performance described (precision, accuracy, interference, etc.) is its standalone performance without a human in the loop for the analytical measurement itself, though a human still interacts with the instrument and interprets the results in a clinical context.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary "ground truth" for the Atellica® CH Creatinine_3 assay's performance is traceability to NIST SRM 967 (a certified reference material for creatinine) and comparison to a legally marketed predicate device (Atellica® CH Creatinine_2) using method comparison validated against CLSI guidelines. This is a form of analytical reference standard and comparative performance to an established method.

7. The sample size for the training set:

   • This device is an analytical chemistry assay, not a machine learning/AI algorithm that requires a "training set" in the computational sense. The "development" or "optimization" of the assay would involve various experimental data, but it's not codified as a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the AI/ML context for this type of device. The assay development would rely on scientific principles of analytical chemistry, reagent formulation, and instrument calibration against known standards.

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The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro UACR Assay: The Nova Allegro UACR Assay is a completely automated assay for the determination of albumin and creatinine in human urine. The results are used to calculate the UACR (Urine Albumin to Creatinine Ratio). Nova Allegro UACR Test Cartridges are the key element a user interacts with to determine the albumin and creatinine levels in a human urine sample. The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with:

• Two analytical bays where the single use test cartridges are analyzed
• Color Touchscreen Display
• Barcode Scanner
• Printer
• Data Export Options
• Ethernet Connection
• USB Port

The provided text is a 510(k) Summary for the Nova Allegro UACR Assay and Analyzer. It details the device's performance testing results. According to the prompt's request, I will extract relevant information to describe the acceptance criteria and the study proving the device meets these criteria.

It's important to note that this document describes a medical device, specifically an in-vitro diagnostic test, not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML specific quality evaluation criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," and details about training sets/ground truth for training, are not applicable in this context. The study performed is a performance validation of a diagnostic assay, comparing its results to a comparative method (CM), not a reader study.

Here's a breakdown of the requested information based on the provided document:

Device: Nova Allegro UACR Assay, Nova Allegro Analyzer
Indications for Use: The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful conclusion of each test and the statement that the data "meets the acceptance criteria" or "demonstrated no significant interference." Specific quantitative acceptance criteria are sometimes stated (e.g.,

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The Creatinine2 assay is used for the quantitation of creatinine in human serum, plasma, or urine on the ARCHITECT c System.

The Creatinine2 assay is to be used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine2 assay is an automated clinical chemistry assay. At an alkaline pH, creatinine in the sample reacts with picric acid to form a creatinine-picrate complex that absorbs at 500 nm. The rate of increase in absorbance is directly proportional to the concentration of creatinine in the sample.

The provided document describes the Abbott Creatinine2 assay, an in vitro diagnostic device, and its performance relative to a predicate device. The information needed to answer the request is primarily found in Section 5: 510(k) Summary (Summary of Safety and Effectiveness), specifically subsections VIII (Summary of Nonclinical Performance) and VII (Comparison of Technological Characteristics).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents the results of various performance studies. The "Reported Device Performance" below is extracted directly from the study results presented in the document. The comparable predicate device values are included for context where available.

Creatinine2 Assay - Performance Summary

2. Sample Size Used for the Test Set and Data Provenance

The document describes several nonclinical laboratory studies.

• Precision (Within-Laboratory): For both Serum/Plasma and Urine, the studies tested 80 replicates per sample type for each of the two controls and three human panels (5 samples total). This was done in duplicate, twice per day, on 20 days. The provenance of the human panels (e.g., country of origin, retrospective/prospective) is not specified, but they are referred to as "human serum panels" and "human urine panels." This data is ex vivo laboratory testing.
• Accuracy: No specific sample size of "patient samples" is given. The study was performed using "material standardized to the Certified Reference Material NIST SRM 967a" for serum/plasma and "material standardized to the Certified Reference Material NIST SRM 914a" for urine.
• Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB/LoD, and for low-analyte level samples for LoQ.
• Linearity: The sample size for linearity is not explicitly stated in terms of number of unique samples, but it covers the analytical measuring interval by spiking and dilution.
• Method Comparison:
  • Serum: 128 samples
  • Urine: 129 samples
    The provenance of these clinical samples (e.g., country of origin, retrospective or prospective) is not explicitly stated.
• Interference: "Each substance was tested at 2 levels of the analyte." No specific sample size (n) for the number of replicates per interference test is given beyond this, nor is the provenance of the base samples used.
• Tube Type: "Samples were collected from a minimum of 40 donors." The provenance is not explicitly stated.

The studies described are nonclinical laboratory studies, primarily involving analytical performance evaluation rather than clinical patient studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable (N/A) to this specific device (Creatinine2 assay). The device is an in vitro diagnostic for quantitative measurement of creatinine, not an imaging device or a device requiring expert interpretation of complex clinical data to establish ground truth for its performance evaluation (e.g., a diagnosis of a disease from imaging). The "ground truth" for its analytical accuracy is typically established against certified reference materials (NIST SRM 967a for serum/plasma and NIST SRM 914a for urine) or reference methods, not by human experts adjudicating cases for a test set.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as #3. Clinical adjudication by multiple experts (like 2+1, 3+1) is typically used for devices that rely on human interpretation of outputs (e.g., medical images, pathology slides) where consensus or expert opinion defines the ground truth for diagnostic accuracy. This device measures a biochemical analyte.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices where human readers or interpreters are part of the diagnostic workflow, such as imaging-based AI tools. The Creatinine2 assay is an automated clinical chemistry assay that directly measures creatinine levels in biological samples and does not involve human image interpretation or a "human-in-the-loop" effectiveness study as typically understood in the context of MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Creatinine2 assay is a standalone (algorithm only) device in the sense that it performs a quantitative measurement without a human-in-the-loop for interpreting the output of the device to arrive at the creatinine value. The performance metrics described (precision, accuracy, linearity, lower limits of measurement, interference, method comparison) are all tests of the device's performance directly, independent of human interpretation or assistance in generating the result.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the Creatinine2 assay was primarily established using:

• Certified Reference Materials: NIST SRM 967a for serum/plasma and NIST SRM 914a for urine were used for accuracy studies.
• Predicate Device/Reference Method: The Creatinine assay (K083809; List No. 3L81) was used as a comparator for the method comparison study to assess substantial equivalence.
• Defined Standards/Controls: For precision and lower limits of measurement, studies used control materials and low-analyte level samples with known or established concentrations to determine repeatability, detection, and quantitation limits.

8. The Sample Size for the Training Set

This information is not applicable (N/A). The Creatinine2 assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the chemical reaction and analytical methods described.

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

This information is not applicable (N/A) for the same reasons as #8.

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The Atellica™ CH Creatinine 2 (Crea 2) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer, Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

The Atellica™ CH Chemistry Calibrator (CHEM CAL) is for in vitro diagnostic use in calibrating the Crea 2 assay using the Atellica™ CH Analyzer.

The Atellica CH Creatinine_2 (Crea_2) assay is based on the reaction of picric acid with creatinine in an alkaline medium as described in the original procedure of Jaffe. Creatinine reacts with picric acid in an alkaline medium to produce a red-colored creatinine-picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration. The Atellica CH Creatinine 2 (Crea_2) assay is a modification of the Jaffe method using rate blanking and intercept correction. Rate blanking is used to minimize bilirubin interference. Also, because nonspecific serum/plasma protein interactions with this reagent have been found to produce a positive bias of approximately 0.3 mg/dL (26.5 umol/L), serum/plasma measurements are automatically corrected by subtracting 0.3 mg/dL (26.5 umol/L) from each result.

The Atellica CH Chemistry Calibrator (CHEM CAL) is a 1 level lyophilized calibrator product prepared from bovine serum base product.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Atellica CH Creatinine 2 (Crea 2) and Atellica CH Chemistry Calibrator (CHEM CAL) devices:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Precision Results:

2. Sample Size Used for the Test Set and Data Provenance

• Detection Limit (LoB/LoD):
  • LoB: 4 samples with no analyte, tested 5 times a day for 3 days (60 reps total).
  • LoD: 4 low analyte samples, tested 5 times a day for 3 days (60 reps total).
• Limit of Quantitation (LoQ):
  • Serum: 10 low samples, 5 replicates each, on 3 reagent lots for 3 days, 5 calibrations per day (75 measurements per reagent lot per sample). Total of 2250 determinations.
  • Urine: Similar setup for urine samples. Total of 2250 determinations.
• Linearity Study:
  • Serum/Plasma: 12 samples (high and low concentration mixes). 5 replicates measured for each sample.
  • Urine: 10 samples (high and low concentration mixes). 5 replicates measured for each sample.
• Precision Studies:
  • Controls, serum, and plasma pools: 80 replicates (n=2 replicates, 2 times a day for at least 20 days).
• Interferences:
  • "Fresh sample pools" containing low or high levels of creatinine in serum and urine. Specific count not given, but refers to testing across these pools.
• Method Comparison (Predicate):
  • Serum: 140 remnant de-identified samples.
  • Urine: 109 remnant de-identified samples.
  • Data Provenance: "Remnant de-identified samples" implies retrospective patient data. "No patient history information was obtained." The studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D personnel.
• Method Comparison (IDMS):
  • Serum: 49 samples.
• Matrix Equivalency:
  • 58 matched serum and lithium heparin plasma samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (Creatinine assay system) does not typically involve human expert adjudication for its ground truth. The "ground truth" for a chemical assay is established through highly accurate reference methods or certified reference materials.

• Ground Truth for Method Comparison: The predicate device, ADVIA Chemistry Enzymatic Creatinine_2 (ECRE_2), served as the comparative "ground truth" for the method comparison study. Additionally, "Isotope Dilution Mass Spectrometry (IDMS)" was used as a reference method for a subset of samples, which is a highly accurate and precise method for determining analyte concentrations and is recognized as a gold standard in clinical chemistry.
• Ground Truth for Calibration/Standardization: The device uses "IDMS Reference Method" for standardization, and the predicate uses "SRM967" (Standard Reference Material 967, which is a NIST standard for creatinine in human serum, often value-assigned by IDMS). These are highly precise and accurate methods, not typically involving human expert consensus in the same way an imaging device would.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by quantitative measurement or comparison to a reference method, not by expert adjudication of human interpretations.

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 is an in-vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

The device itself is a standalone, automated analytical system (Atellica CH Analyzer) that performs the creatinine assay. The performance results reported (LoB, LoD, LoQ, Linearity, Precision, Interference, Method Comparison) represent the standalone performance of the assay on the analyzer. There is no human-in-the-loop component for the measurement of creatinine by this system.

7. The Type of Ground Truth Used

• Reference Methods:
  • The predicate device (ADVIA Chemistry Enzymatic Creatinine_2) was used as a reference for method comparison.
  • Isotope Dilution Mass Spectrometry (IDMS) was used as a highly accurate reference method for a subset of serum samples. This is considered a gold standard for creatinine measurement.
• Reference Materials: Standardization mentions "IDMS Reference Method," which implies traceability to primary reference materials. The predicate mentions SRM967, a certified reference material.
• Defined Protocols: CLSI (Clinical and Laboratory Standards Institute) protocols (EP17-A2, EP05-A3, EP06-A, EP7-A2, EP09-A3, EP28-A3c) were followed for various performance evaluations, which define how to establish performance characteristics against expected statistical and analytical metrics.

8. The Sample Size for the Training Set

Not explicitly mentioned in the provided text as a "training set" in the context of machine learning, which is typically what this question implies. For an IVD assay, method development and initial optimization would involve numerous experiments and samples, but these are typically not referred to as a "training set" in the AI sense. The text focuses on the validation studies performed to demonstrate performance.

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

As above, the concept of a "training set" with established ground truth as used in AI/ML is not directly applicable here. The development of an IVD assay involves extensive R&D, where analytical methods are refined to accurately measure the analyte. The "ground truth" during this development phase would be established by reference methods or gravimetric/volumetric preparations of known concentrations, similar to how the validation ground truth is established.

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The CRE2 method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The CRE2 method uses a modified kinetic Jaffe technique. In the presence of a strong base such as sodium hydroxide, picrate reacts with creatinine to form a red chromophore. The rate of increasing absorbance at 510 nm due to the formation of this chromophore is directly proportional to the creatinine concentration in the sample and is measured using a bichromatic (510, 600nm) rate technique. Bilirubin is oxidized by potassium ferricyanide to prevent interference.

The provided text describes a 510(k) premarket notification for a new in vitro diagnostic device, the Dimension® Creatinine (CRE2) Flex® reagent cartridge. This document is a summary of the safety and effectiveness information, comparing the new device to a predicate device already on the market.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for performance parameters in a pass/fail format. Instead, it provides the results of various performance studies and implies that these results demonstrate substantial equivalence to the predicate device and/or meet established industry guidelines (CLSI). The acceptance criteria are implicitly defined by what is considered "substantially equivalent" or within acceptable limits as per CLSI guidelines.

Below is a table summarizing the reported device performance, categorized by the studies conducted. It's important to note that specific numerical acceptance criteria (e.g., "slope must be between 0.98 and 1.02") are not explicitly stated, but the reported values passed the FDA's substantial equivalence review.

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

• Method Comparison (vs. Predicate CREA Assay):
  • Serum: 191 remnant de-identified patient samples.
  • Urine: 113 patient samples.
  • Provenance: Remnant de-identified samples. "No patient history information was obtained on these samples." The studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel, implying a US-based setting. The data is retrospective as it used "remnant de-identified serum/urine samples."
• Method Comparison (vs. IDMS Reference Method):
  • Serum: 48 remnant de-identified patient samples.
  • Provenance: Remnant de-identified samples. "No patient history information was obtained on these samples." Conducted internally by Siemens Healthcare Diagnostic Inc. R&D. Retrospective.
• Serum Plasma Equivalency:
  • Samples: 56 matched serum and lithium heparin plasma samples.
  • Provenance: "All samples in the study were fresh and never frozen." The eight spiked sample sets were prepared. Conducted internally by Siemens Healthcare Diagnostic Inc. R&D. Retrospective, likely sourced from a local population.
• Precision:
  • Samples: Two serum pools, three levels of BioRad Multiqual material, two levels of BioRad Liquicheck material, and two urine pools. Testing involved 20 days with 2 separate runs and 2 test samples for each material. The specific number of individual patient samples is not given, as this study uses control materials and pools.
  • Provenance: Not specified, but likely prepared internally or from commercial sources.
• Limit of Blank/Detection (LoB/LoD):
  • Samples: 4 samples with no analyte (for LoB), 4 low patient serum/urine samples (for LoD). Each tested for 3 days, one run per day, across 2 reagent lots.
  • Provenance: Not specified, but generally prepared internally with blank/low-level samples.
• Linearity (Measurement Range):
  • Samples: 12 equally spaced serum samples and 12 urine samples.
  • Provenance: Prepared by mixing high and low creatinine concentration samples.
• Analytical Specificity (Interference):
  • Samples: Not specified in terms of number of patient samples, but involved "fresh sample pools containing either low or high levels of creatinine analyte in both serum pools and urine pools." These pools were spiked with various interfering substances.
  • Provenance: Likely developed from internal pools and commercially available substances.

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

This section is not applicable to this type of device (in vitro diagnostic for quantitative measurement of creatinine). The "ground truth" for clinical chemistry assays like creatinine is established by:

• Reference methods (e.g., IDMS, considered the "gold standard" for creatinine measurement in some contexts).
• Predicate devices (already cleared and established to perform reliably).
• Known concentrations in control materials or spiked samples.

There are no human "experts" (like radiologists interpreting images) involved in establishing ground truth for the test set in this context. The "personnel carrying out the study were laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept of "adjudication" is typical for studies involving human interpretation (e.g., medical imaging, pathology slides) where there might be disagreement among readers. For an automated in vitro diagnostic device, the measurement is quantitative and typically objective. Therefore, an adjudication method for the test set is not applicable. The "ground truth" is determined by instrumental readings and reference methods.

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

An MRMC study is not applicable here. This device is a fully automated in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Its performance is evaluated against chemical reference methods and a predicate device, not in terms of how it assists human interpretation.

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

Yes, this entire submission and its performance data represent a standalone (algorithm only) performance evaluation. The device is an automated clinical chemistry system that measures creatinine levels directly from biological samples (serum, plasma, urine) without human intervention in the interpretation of the core measurement. The reported results (slope, intercept, correlation, precision, LoB/LoD, linearity, interference) directly reflect the device's inherent analytical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for evaluating the Dimension® Creatinine (CRE2) Flex® reagent cartridge includes:

• Reference Method: The IDMS (Isotope Dilution Mass Spectrometry) method for creatinine measurement. This is considered a highly accurate and precise reference method.
• Predicate Device: The Creatinine Method for Use on the Dimension® Clinical Chemistry System (CREA, K925668). The predicate device's cleared performance serves as a benchmark for demonstrating substantial equivalence.
• Known Concentrations: For studies like precision, LoB/LoD, linearity, and interference, known concentrations of analytes in control materials, spiked samples, or blank samples serve as the ground truth.

8. The sample size for the training set

This document describes a 510(k) submission for an in vitro diagnostic reagent cartridge that uses a modified kinetic Jaffe technique (a traditional chemical assay), not a machine learning or AI-based device. Therefore, the concept of a "training set" for an algorithm is not applicable. The "training" for such a device would refer to its development and optimization based on chemical principles, rather than data-driven machine learning.

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

As answered in point 8, the device does not employ a training set in the context of an AI/ML algorithm. Its "ground truth" for development and calibration would be rooted in established chemical and analytical principles, reference measurement procedures (like IDMS), and potentially existing characterized samples. The manufacturing process of reagents, calibrators, and the instrument's detection capabilities are based on fundamental scientific understanding rather than a data training process as understood in AI/ML.

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The CRE2 method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Dimension Vista® Creatinine (CRE2) Flex® reagent cartridge uses a modified kinetic Jaffe technique. In the presence of a strong base such as sodium hydroxide, picrate reacts with creatinine to form a red chromophore. The rate of increasing absorbance at 510 nm due to the formation of this chromophore is directly proportional to the creatinine concentration in the sample and is measured using a bichromatic (510, 577 nm) rate technique.

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® System Creatinine (CRE2) Flex® reagent cartridge, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Method Comparison (Predicate Device):
     • Serum: 140 patient samples. Remnant de-identified serum samples. No patient history. Inclusion/exclusion criteria not applicable. Both native and spiked samples.
     • Urine: 112 patient samples. Remnant de-identified urine samples (implied). No patient history. Inclusion/exclusion criteria not applicable.
   • Method Comparison (IDMS Reference Method):
     • Serum: 48 patient samples. Remnant de-identified serum samples. No patient history. Inclusion/exclusion criteria not applicable. All native samples.
   • Serum Plasma Equivalency: 56 matched serum and lithium heparin plasma samples. All samples fresh and never frozen. 8 spiked sample sets.
   • Precision: Not a direct "test set" in the sense of patient samples, but testing involved: 2 serum pools, 3 levels of BioRad Multiqual material, 2 levels of BioRad Liquicheck material, and 2 urine pools. Each tested multiple times (over 20 days, 2 runs, 2 samples per run).
   • Limit of Blank/Detection (Serum): 4 samples with no analyte (N=5 reps for 3 days), 4 low patient serum samples (N=5 reps for 3 days).
   • Limit of Blank/Detection (Urine): 4 samples with no analyte (N=5 reps for 3 days), 4 low patient urine samples (N=5 reps for 3 days).
   • Linearity: 12 equally spaced samples for serum, 12 for urine.
   • Analytical Specificity (Interference): Low (~1.5 mg/dL) and High (~5.0 mg/dL) creatinine serum pools; Low (~40 mg/dL) and High (~175 mg/dL) creatinine urine pools. Number of individual samples/tests per interferent is not explicitly stated but implied to be sufficient for creating means and controls.
   • Expected Values:
     • Serum and Plasma: 53 male donors, 40 female donors (all normal healthy adults).
     • Urine: 22 male donors, 20 female donors (all normal healthy adults).
   • Reportable Range Dilution: N=5 replicates for each dilution study (serum and urine).

   Data Provenance: The studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel. Remnant de-identified samples were used for method comparison studies, implying retrospective or archived samples. Patient history was not obtained. The origin of the patient samples (e.g., country) is not specified, but the internal R&D location would presumably be Newark, DE, USA based on the applicant's address.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention the use of experts to establish ground truth for the test set in the context of clinical interpretation. For method comparison, the "ground truth" for the new device was established by comparison to a legally marketed predicate device (Dimension Vista® Creatinine (CREA) Flex® reagent cartridge) and the IDMS reference method. These are analytical "gold standards" rather than expert interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. The reported studies are analytical performance evaluations of a quantitative laboratory test, not diagnostic interpretations requiring adjudication.

4. 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 is a quantitative in vitro diagnostic test for creatinine, not an imaging or interpretive device that would typically involve human readers or AI assistance in the way an MRMC study would assess.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, these are all standalone (algorithm only) performance studies. The device itself performs the quantitative measurement of creatinine from samples without human interpretation in the loop of the measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Method Comparison studies: The ground truth was established by two primary methods:
     • Comparison to a predicate device (Dimension Vista® Creatinine (CREA) Flex® reagent cartridge).
     • Comparison to the IDMS reference method (Isotope Dilution Mass Spectrometry), which is a highly accurate and precise analytical method often considered a "gold standard" for creatinine measurements.
   • For Expected Values studies: Published reference ranges in scientific literature (e.g., Tietz 1999, Clin Chem 54:3 (2008), Clin Chem Acta 344 (2004) 137-148) served as the basis for validating the established ranges for the new device.
   • For LoQ validation: Allowable total error limits published by regulatory and accreditation bodies (CLIA, CAP, AAB, NYS, WSLH) were used. The reference values are traceable to IDMS.

7. The sample size for the training set:
   Not applicable in the context of typical AI/machine learning studies. This device is a reagent cartridge for an automated clinical chemistry system, not an AI or machine learning algorithm that undergoes 'training' in the conventional sense with labeled data. The development and internal refinement of the reagent formulation and measurement parameters would be analogous to "training" but is not quantified in terms of a discrete sample set size like this.

8. How the ground truth for the training set was established:
   Not applicable for the same reasons as above. The "ground truth" for developing such a system would involve rigorous analytical chemistry principles, extensive experimentation, and calibration using traceable standards (e.g., NIST SRM 914a (IDMS assigned crystalline creatinine standard)).

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The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.

Not Found

The provided document is an FDA 510(k) clearance letter for the EasyRA Creatinine Reagent. It states that the device is substantially equivalent to a predicate device for measuring creatinine in serum and plasma.

However, this document does not contain the specific information required to answer your request about acceptance criteria and study details. The 510(k) clearance letter itself is a summary of the FDA's decision, not the full submission that would detail the performance studies and acceptance criteria.

To answer your questions, one would need access to the actual 510(k) premarket notification submission for K123586, which would include the performance data and the study design.

Therefore, I cannot provide the requested table and study details based solely on the provided text. The document confirms the device's indications for use: "The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis." but does not elaborate on the performance characteristics or the studies conducted to establish substantial equivalence.

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ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). 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.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

The provided text describes the acceptance criteria and performance data for the ABX PENTRA Creatinine 120 CP reagent and associated calibrators/controls, for use on the ABX PENTRA 400 clinical chemistry analyzer.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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A creatinine test system is a device intended to measure creatinine levels in serum, plasma and urine. 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.

Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate in the reagent to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the supporting study:

The document describes a Special 510(k) submission for a modified Creatinine assay for urine application. The acceptance criteria for the modified assay are implicitly based on demonstrating substantial equivalence to a predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and a previously cleared version of the Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems.

The primary study conducted is a comparative performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "acceptable correlation" and "similar Performance Characteristics," implying the reported values met predetermined acceptance criteria for substantial equivalence to the predicate and the previously cleared device. Specific quantitative acceptance thresholds for correlation coefficients, slopes, intercepts, or %CV are not explicitly listed, but the reported values are presented as meeting these criteria.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not explicitly state the sample size (number of urine samples) used for the comparative performance studies. It mentions "Comparative performance studies were conducted" but does not quantify the number of samples.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It only indicates that "Comparative performance studies were conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of diagnostic device (Creatinine assay) does not rely on human experts to establish "ground truth" for individual test results in the way image analysis or clinical diagnosis devices do. The "ground truth" for the test set is established by the performance of the predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared device (Creatinine assay on the Abbott AEROSET® System). The performance metrics of the modified device are compared against the measurements obtained from these established methods.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative chemical assay, "adjudication" in the sense of multiple human readers resolving discrepancies is not relevant. The comparison is made directly between numerical measurements from different instruments/assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation (e.g., radiologists reading images) where the AI assists the human. This 510(k) is for an in vitro diagnostic assay, which provides a direct quantitative measurement, not an interpretation aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence, standalone performance was assessed. The Creatinine assay itself is a standalone algorithm/method that directly measures creatinine levels. Its performance is evaluated by comparing its quantitative results against those of predicate methods. There is no "human-in-the-loop" once the sample is loaded and the assay begins to run.

7. The Type of Ground Truth Used

The ground truth for evaluating the modified Creatinine assay is the measurements obtained from the legally marketed predicate device (Roche Creatinine assay urine application on the Hitachi 917 Analyzer) and the previously cleared version of the same Creatinine assay (on the Abbott AEROSET® System). This is a form of comparative measurement ground truth, where the reference standard is another recognized and validated method.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm that learns from data. This submission is for an assay, not a machine learning algorithm that requires a separate training phase. The "modifications" were to calibration and assay parameters, implying adjustments based on known chemical principles and potentially internal studies, rather than a data-driven machine learning training set.

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

Not applicable. As noted above, this is an in vitro diagnostic assay based on chemical reactions, not a machine learning algorithm with a training set. The "ground truth" for the calibration and assay parameters would be based on the principles of the Jaffe reaction, and reference standards like NIST SRM 914 and NIST SRM 967, which are IDMS traceable.

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Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). 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.

ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels.

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:

Acceptance Criteria and Device Performance

The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.

ABX PENTRA Creatinine 120 CP

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