Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Atellica® CH Enzymatic Creatinine 3 (ECre3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin and dipotassium EDTA), 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 ECre3 assay measures the concentration of creatinine through a series of coupled enzymatic reactions and is based upon the method developed by Masaru and Mitsutaka. The Atellica CH ECre3 assay uses a series of coupled enzymatic reactions. In a "pretreatment" reaction, endogenous creatine and sarcosine are removed from a test sample by creatinase and sarcosine oxidase. The level of creatinine in a test sample is then determined through coupled enzymatic reactions. First, creatinine is enzymatically converted by creatininase into creatine. Creatine is then enzymatically converted to sarcosine by creatinase. This is followed by the oxidation of sarcosine by sarcosine oxidase to produce hydrogen peroxide. In the presence of peroxidase, the hydrogen peroxide allows for the oxidative condensation of 4-aminoantipyrine and N-ethyl-N-(3-methylphenyl)-N'-succinyl-ethylenediamine to produce a reddish purple quinone pigment. The absorbance of this quinone pigment is measured as an endpoint reaction at 545/694 nm.

This document describes the performance of the Atellica® CH Enzymatic Creatinine 3 (ECre3) assay, a new in vitro diagnostic device for quantitative determination of creatinine. The information provided is for a 510(k) Premarket Notification to the FDA, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" here refers to the performance thresholds that the new device must meet to show it functions as intended and is comparable to the predicate device. The "study" refers to the analytical performance validation studies conducted.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Sizes and Data Provenance

Since this is an in vitro diagnostic (IVD) device, the "acceptance criteria" are typically defined as performance specifications that demonstrate the device's analytical accuracy, precision, linearity, and freedom from interferences. These are not clinical acceptance criteria in the sense of diagnostic accuracy to a specific disease state, but rather analytical performance metrics. The document compares the new device (candidate) to a predicate device and established standards.

Data Provenance (General): The document does not explicitly state the country of origin for the patient samples used in method comparison or specimen equivalency studies. It also does not specify if the studies were retrospective or prospective, though for IVD analytical performance, they are typically prospective analytical studies using characterized samples (pooled, spiked, or real patient samples collected for the study).

Regarding items 3-9 for this IVD document:

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

• For an IVD device like this, "ground truth" for analytical performance studies is established by reference methods (e.g., Isotope Dilution Mass Spectrometry - IDMS, as seen in the assay comparison) or against a legally marketed predicate device (ADVIA Chemistry ECRE_2 assay). It is not established by human experts (like radiologists reading images) for diagnostic accuracy or consensus in the typical sense for medical imaging or clinical decision support AI. The "experts" would be the metrologists or lab professionals validating the reference methods according to CLSI guidelines.

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

• Not applicable in the context of an IVD analytical performance study. Adjudication methods are relevant for subjective interpretations, like radiology image reads or pathological diagnoses, where human variability exists and a consensus "ground truth" needs to be established. Here, the "truth" is quantitative measurement by reference methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (often involving human readers and AI) where subjectivity and reader variability are factors. This submission is for an in vitro diagnostic assay, which provides quantitative values, not an imaging-based AI or a system that aids human interpretation in a subjective setting.

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

• This is inherently a "standalone" device in the sense that it is an automated laboratory assay. Its performance is measured directly (algorithm only) against reference methods or the predicate, as presented in the analytical performance section. There isn't a "human-in-the-loop" component in its operation or interpretation beyond the lab professional running the analyzer and reviewing results.

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

• The ground truth for this device's performance evaluation is established by:
  • Reference Methods: Specifically, Isotope Dilution Mass Spectrometry (IDMS) for creatinine measurements, which is a highly accurate and precise chromatographic-mass spectrometric method. This is considered the "gold standard" for creatinine measurement.
  • Comparison to a Legally Marketed Predicate Device: The ADVIA® Chemistry Enzymatic Creatinine_2 (ECRE_2) assay. The performance against the predicate is used to demonstrate "substantial equivalence."
  • Internal analytical validation: Using controlled samples (e.g., spiked samples, control materials) for precision, linearity, interference studies, where the "ground truth" is the known concentration or expected behavior of the sample.

8. The sample size for the training set:

• This document describes the validation of the device's performance, not its development or "training." For an IVD assay (like a chemical reagent and analyzer system), there isn't a "training set" in the machine learning sense. The assay is based on established enzymatic reaction principles, not on learned patterns from a "training set" of data. Therefore, this concept is not applicable here.

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

• Not applicable, as there is no "training set" for this type of IVD device. The assay's chemical reactions and measurement principles are intrinsically defined, not learned from data.

Ask a specific question about this device

Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.

Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.

The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).

Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:

1. A Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."

Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.

Implied Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction. 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.

Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction.

The Horiba ABX SAS Yumizen C1200 Creatinine PAP device is an in vitro diagnostic intended for the quantitative determination of Creatinine in human serum, plasma, and urine. Its performance was evaluated through various analytical studies to demonstrate substantial equivalence to its predicate device, the ABX Pentra Enzymatic Creatinine CP.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Measuring Range:
  • Limit of detection and quantitation: Determined according to CLSI guideline EP17-A2. (Specific sample size not provided in the summary but typically involves multiple replicates of low-concentration samples).
  • Linearity: Determined according to CLSI guideline EP06-A. (Specific sample size not provided in the summary but involves multiple concentrations with replicates).
• Accuracy and Precision:
  • Instrument Variability (Serum/Plasma & Urine): 240 measurements (20x2x2 means 20 replicates for each of 3 samples, on 2 runs for 2 instruments over a certain period - or 20 days x 2 runs/day x 2 instruments). The samples were control materials and native samples.
  • Lot-to-Lot Variability (Serum/Plasma & Urine): 90 measurements (3x5x2x3 implies 3 lots, 5 days, 2 runs/day, 3 samples). The samples were control materials and native samples.
• Interferences: Not explicitly stated, but typically involves testing known concentrations of interferents in base samples.
• Matrix Comparison: 84 paired samples (serum and lithium heparin plasma) from single donors.
• Method Comparison:
  • Serum/Plasma: 103 native human serum samples. Data provenance: collected from CHU Nîmes (University Hospital Center). Retrospective (remnants).
  • Urine: 129 native human urine samples. Data provenance: collected from routine clinical laboratory. Retrospective (remnants).
• Reagent Stability: Determined according to CLSI guideline EP25-A. (Specific sample size not provided).
• Reference Range Verification:
  • Serum/Plasma - Men: 45 "normal samples" from a blood bank.
  • Serum/Plasma - Women: 41 "normal samples" from a blood bank.
  • Children & Urine: Verification could not be made due to lack of availability of samples from healthy pediatric patients/healthy people.

3. 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 this device, which is a quantitative in vitro diagnostic for creatinine levels. For such devices, ground truth is typically established by:

• A reference method (e.g., mass spectrometry) for accuracy studies.
• The established values of control materials.
• The results from a legally marketed predicate device (as seen in method comparison).
• Literature values for reference range verification.

4. Adjudication method for the test set

Not applicable. This is a quantitative diagnostic device, not one requiring expert adjudication of results.

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 a quantitative diagnostic device, not an AI-assisted diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.

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

This is a standalone in vitro diagnostic device (reagent and instrument system). Its performance described above (e.g., precision, accuracy, linearity, interference) represents the algorithm-only (device-only) performance, without human interpretation of the result influencing the quantitative output.

7. The type of ground truth used

• Measuring Range, Accuracy, Precision, Interferences, Reagent Stability: Internal specifications, established reference materials (controls), and recognized scientific methods (e.g., spiked samples for linearity and interference).
• Matrix Comparison: Paired samples from the same donor, with comparison between results from serum and plasma. The expectation is that the creatinine value should be the same across matrices for the same individual.
• Method Comparison: The predicate device's results (ABX Pentra Enzymatic Creatinine CP) served as the reference for comparison using method comparison studies (Passing Bablok regression).
• Reference Range Verification: Reference ranges cited in scientific literature (e.g., Mazzachi BC et al., Schlebusch Soldin SJ et al., Roberts WL et al.) were used for verification against measured values in "normal" samples.

8. The sample size for the training set

The document describes performance evaluation studies (validation) rather than a clear "training set" for an algorithm. For a device like this, the "training" usually refers to the development and optimization of the reagent formulation and instrument parameters. The specific sample sizes used for this developmental phase are not detailed in the summary. The provided sample sizes are for the analytical performance studies which are typically considered validation.

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

As there isn't a "training set" in the context of machine learning, this question isn't directly applicable. For the development of an IVD like this, ground truth would be established during the R&D phase through:

• Using purified creatinine standards.
• Comparison with established and highly accurate reference methods (e.g., isotope dilution mass spectrometry, IDMS).
• Clinical samples with results from well-characterized, clinically accepted methods.

Ask a specific question about this device

For the quantitative determination of creatine kinase activity in serum and plasma. Rx only.

Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infaction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

The Pointe Scientific Creatine Kinase (CK) Reagent Set consists of ready-to-use liguid reagents:

• . CK R1 (buffer) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L; NADP 2.0 mmol/L: HK (Baker's yeast) 2.5 KU/L: Glucose 20.0 mmol/L: Magnesium Acetate 10.0 mmol/L; EDTA 2.0 mmol/L and N-acetylcysteine (NAC) 20.0 mmol/L.
• . CK R2 (enzyme reagent) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L: ADP 2.0 mmol/L: AMP 5.0 mmol/L: Diadensosine pentaphosphate 10.0 mmol/L: Creatine phosphate 30.0 mmol/L; G6PDH (Baker's yeast) 1.5 KU/L and EDTA 2.0 mmol/L.

The kinetic procedure presented is a modification of Szasz of the Rosalki technique, which optimizes the reaction by reactivation of CK activity with N-actyl-L-cysteine (NAC).

Creatine Kinase specifically catalyzes the transphosphorylation of ADP to ATP. Through a series of coupled enzymatic reactions, NADPH is produced at a rate directly proportional to the CK activity. The method determines the NADPH absorbance increase per min at 340 nm.

The provided document describes the analytical performance studies for the Pointe Scientific Creatine Kinase (CK) Reagent Set, which supports its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study details:

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

The document doesn't explicitly state "acceptance criteria" in a separate table for each test. Instead, it presents the study results and implies that these results were considered acceptable for demonstrating substantial equivalence. For some tests, like Linearity, an acceptable deviation is stated.

However, based on the provided performance data, we can infer the acceptance criteria that the manufacturer likely aimed for to support their claims.

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

• Method Comparison (Serum):
  • Sample Size: 120 de-identified remnant serum samples. 4 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified, but likely within the US given the FDA submission.
• Method Comparison (Plasma):
  • Sample Size: 123 de-identified remnant plasma samples. 2 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified.
• Precision Studies:
  • Sample Size: 2 commercial quality controls, 3 serum pools, and 3 plasma pools. Each pool/control was tested in duplicate twice per day for 20 days (n=80 per sample type).
  • Data Provenance: Not explicitly stated, but common practice is for manufacturers to prepare pools or use commercially available controls.
• Linearity/Assay Range Study:
  • Sample Size: A set of 12 serum samples and 12 plasma samples (prepared by admixture of high-level and low-level pools).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Detection Capability (LoB, LoD, LoQ):
  • LoB: Saline (1 sample * 20 repetitions * 3 days).
  • LoD: 20 low-level depleted serum samples and 20 depleted plasma samples.
  • LoQ: 5 low activity samples (each run in 8 duplicates over 5 days).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Dilution Recovery Studies:
  • Sample Size: Three contrived high-level samples for both serum and plasma.
  • Data Provenance: Not explicitly stated, likely prepared in-house.
• Analytical Specificity (Endogenous Substances):
  • Sample Size: Not explicitly stated, but interference testing was conducted using "randomly selected serum and plasma samples ranging from 43 U/L to 268 U/L."
  • Data Provenance: Not explicitly stated.

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

This is a diagnostic reagent for quantitative determination of an analyte (Creatine Kinase), not an imaging or qualitative diagnostic device requiring expert interpretation of results to establish ground truth.

• Ground Truth for Method Comparison: The predicate device's results (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) serve as the "reference" or "ground truth" for comparison. This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices. No human experts are used to establish ground truth in this context; rather, the established method of the predicate device is the reference.
• Ground Truth for other studies (Precision, Linearity, Detection, Dilution Recovery, Specificity): The "ground truth" is typically established by the analytical method itself, or by preparing samples with known concentrations/characteristics, without the need for human expert consensus.

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

No adjudication method is relevant or mentioned as this device measures an objective biochemical marker. The 'ground truth' is the quantitative measurement itself or the reference method's result.

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:

No. This is not applicable. The device is a diagnostic reagent for quantitative measurement of creatine kinase, not an AI-powered diagnostic system for image interpretation or a device requiring human readers/scorers. Therefore, MRMC studies are not relevant.

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

The device is a reagent set used on an automated chemistry analyzer (Shenzhen Mindray BA-800M Chemistry Analyzer). The performance studies presented are for the "algorithm only" in the sense that they demonstrate the analytical performance of the reagent on the analyzer without human interpretation of the raw data to generate the numerical result. The "human-in-the-loop" would be a lab technician performing the test and reviewing the results, but the analytical performance itself is standalone.

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

• Method Comparison: The results obtained from the legally marketed predicate device (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) served as the reference for comparison.
• Precision, Linearity, Detection, Dilution Recovery, Analytical Specificity: Ground truth is based on the inherent analytical properties of the method/reagent including samples with known concentrations (e.g., prepared standards, spiked samples, qualified controls, or established reference material). Linearity was assessed against expected values based on known admixtures. Detection limits were determined using statistical methods on low-level and blank samples.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) submission for a diagnostic reagent. This device is not an AI/machine learning algorithm that requires training data. The studies performed are analytical validation studies.

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

Not applicable, as there is no training set for this type of medical device.

Ask a specific question about this device

Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Yumizen C1200 Creatinine Jaffé reagent 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.

Not Found

The provided FDA 510(k) summary describes the analytical performance characteristics of the Yumizen C1200 Calcium AS and Yumizen C1200 Creatinine Jaffé reagents when used with the Yumizen C1200 clinical chemistry analyzer. The document focuses on demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study designs based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data across several analytical characteristics. For some categories, explicit "acceptance criteria" are mentioned (e.g., CV limits for precision), while for others, the results are presented as factual measurements from the studies conducted.

Yumizen C1200 Calcium AS

• Limit of detection: 0.12 mmol/L (0.48 mg/dL)
• Limit of quantitation: 0.14 mmol/L (0.57 mg/dL)
• Linearity: 0.00 to 4.84 mmol/L (0.00 to 19.40 mg/dL)
• Measuring range: 1.00 - 4.50 mmol/L (4.0 - 18.05 mg/dL)
• Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL)
  Urine:
• Limit of detection: 0.06 mmol/L (0.24 mg/dL)
• Limit of quantitation: 0.16 mmol/L (0.64 mg/dL)
• Linearity: 0.00 to 4.84 mmol/L (0.00 - 18.60 mg/dL)
• Measuring range: 0.16 to 4.5 mmol/L (0.64 - 18.05 mg/dL)
• Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL) |
  | Precision (Serum/Plasma) | Within run (CV limits): 1.2% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels.
  Total precision (CV limits): 1.6% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels. | Within-Run (%CV):
• Control N: 0.6%
• Control P: 0.5%
• Sample 1: 0.8%
• Sample 2: 0.6%
• Sample 3: 0.5%
  Total (%CV):
• Control N: 1.5%
• Control P: 1.4%
• Sample 1: 1.7%
• Sample 2: 1.6%
• Sample 3: 1.8%
  (Note: "Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the p-value with 5% acceptable remains acceptable for all the samples tested.") |
  | Precision (Urine) | Within run (CV limits): 3.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels.
  Total precision (CV limits): 4.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels. | Within-Run (%CV):
• Control L1: 0.7%
• Control L2: 0.5%
• Sample 1: 1.6%
• Sample 2: 0.8%
• Sample 3: 0.7%
• Sample 4: 0.6%
• Sample 5: 0.6%
  Total (%CV):
• Control L1: 3.8%
• Control L2: 3.9%
• Sample 1: 2.6%
• Sample 2: 2.1%
• Sample 3: 2.0%
• Sample 4: 1.7%
• Sample 5: 1.6%
  (Note: "The results are within the specifications.") |
  | Interferences | Acceptable bias is +/-10% of the value without interfering substances. | Highest values for which no interferences > 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen (for serum/plasma) and additionally Glucose for urine. |
  | Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.1159, Slope 0.9423, Correlation 0.997. (Plasma vs. Predicate) |
  | Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.976) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.06, Slope 1, Correlation (r2) 0.976. (Native serum vs. Predicate) |
  | Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Calcium (mmol/L): Intercept +0.1381, Slope 0.9436, Correlation (r2) 0.995. (Native urine vs. Predicate) |
  | Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
  | Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 6 weeks (on board). |
  | Reference Range | Verification studies support established ranges from literature. | Serum/Plasma (Adults): 2.15 - 2.55 mmol/L (8.6 - 10.2 mg/dL)
  Urine (24h): Women 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen, Glucose, Total Proteins (for serum/plasma) and additionally Glucose for urine (not listed, but implied from calcium's urine list). Note: Glucose for Creatinine urine interference is not listed in the table, but was for Calcium urine. Acetaminophen listed for Creatinine serum/plasma but not urine, similar to Calcium. |
  | Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.999) suggest equivalence to predicate. | Creatinine (µmol): Intercept -7.102, Slope 1.087, Correlation 0.999. (Plasma vs. Predicate) |
  | Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Creatinine (µmol/L): Intercept 9.158, Slope 0.9633, Correlation (r2) 0.995. (Native serum vs. Predicate) |
  | Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Creatinine (mmol/L): Intercept -41.4, Slope 0.9483, Correlation (r2) 0.997. (Native urine vs. Predicate) |
  | Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
  | Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 7 days (on board). |
  | Calibration Stability | At least 3 days (Predicate). | 24 hours (Candidate). (Note: Candidate's calibration stability is shorter than predicate.) |
  | Reference Range | Verification studies support established ranges from literature. | Serum/Plasma: Mens: 62-106 µmol/L (7-12 mg/dL), Womens: 44-80 µmol/L (5-9 mg/dL)
  Urine (24h): Men: 14-26 mg/kg/day (124-230 µmol/kg/day), Women: 11-20 mg/kg/day (97-177 µmol/kg/day) |

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

• Yumizen C1200 Calcium AS:

  • Matrix Comparison (Plasma): 108 individual plasma samples. Data provenance: Not specified (but likely from within France, given the manufacturer's location).
  • Method Comparison (Serum/Plasma): 166 native serum samples. Data provenance: Not specified.
  • Method Comparison (Urine): 105 native urine samples. Data provenance: Not specified.
  • Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. This is for multiple runs/days/instruments. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
  • Reference Range Verification (Serum/Plasma): 40 "normal samples" from blood bank.
  • Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
  • Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.

• Yumizen C1200 Creatinine Jaffé:

  • Matrix Comparison (Plasma): 69 individual plasma samples. Data provenance: "individual donors from blood bank." Not explicitly stated country of origin.
  • Method Comparison (Serum/Plasma): 131 native samples. Data provenance: Not specified.
  • Method Comparison (Urine): 148 native samples. Data provenance: Not specified.
  • Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
  • Reference Range Verification (Serum/Plasma): 35 "normal samples" from blood bank (Men), 25 "normal samples" from blood bank (Women).
  • Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
  • Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.

Data Provenance (General): The general provenance of the "individual donors from blood bank" for Matrix Comparisons (plasma) is not specified geographically. The studies are described as analytical performance evaluations, suggesting they are prospective studies conducted in a controlled laboratory setting.

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

This document describes the performance of in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The concept of "ground truth" here is tied to the accurate and precise measurement of these analytes by established laboratory methods, often against a reference method or predetermined values for controls/calibrators.

• Ground Truth Establishment: For IVD devices, "ground truth" is typically established by:
  • Certified Reference Materials/Control Materials: These have assigned values determined by highly accurate reference methods or extensive inter-laboratory studies.
  • Reference Methods: Highly accurate and precise analytical methods used to determine true values (e.g., isotope dilution mass spectrometry for some analytes).
  • Predicate Devices: Comparison against an already cleared and widely accepted device.
  • Expert Consensus/Pathology/Outcomes Data: These are generally relevant for diagnostic imaging or clinical decision support AI, not typically for quantitative chemical assays like Calcium and Creatinine.

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this type of IVD testing. The focus is on analytical performance metrics (linearity, precision, interference, method comparison to a predicate).

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., reading medical images) is involved and multiple experts are used to reach a consensus for ground truth. This document describes the analytical performance of quantitative chemical assays, where measurements are objective.

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 used for evaluating diagnostic imaging or AI systems that assist human readers in interpretation. This document pertains to the analytical performance of reagents for quantitative chemical measurements, which do not involve human "readers" in the context of interpretation.

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

Yes, in a sense. The studies described (e.g., measuring range, precision, interference, method comparison) evaluate the performance of the reagent and instrument system in generating a quantitative value for Calcium and Creatinine. This is akin to a "standalone" performance evaluation of the reagent system itself, without human interpretation of the final result, beyond standard laboratory quality control and result review. The device output is a numerical value, not an interpretation requiring human assistance.

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

The ground truth for these studies is established through:

• Reference Methods/Assigned Values: For precision studies, control materials with known target values are used. For linearity, serially diluted samples or spiked samples with known concentrations are employed.
• Comparison to a Predicate Device: For method comparison, patient samples are tested on both the candidate device and a legally marketed predicate device, with the predicate serving as the reference for equivalence.
• Literature Reference Intervals: For reference range verification, the device's measurements on "normal samples" are compared against established reference intervals from scientific literature.

8. The sample size for the training set:

Not applicable. This is an IVD reagent and instrument system, not an AI/Machine Learning model that undergoes a distinct "training" phase with a large dataset in the way a medical image analysis algorithm would. The development of reagents involves chemical formulation and optimization, and instrument calibration relies on calibrator materials, not necessarily "training datasets" in the AI sense.

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

Not applicable for the same reasons as point 8. The "ground truth" for calibrators (used for instrument calibration, which is analogous to "training" in the sense of setting up the system for accurate measurement) is typically established by the calibrator manufacturer using highly accurate reference methods and/or extensive certification processes. The document mentions "Yumizen C1200 Multical" as the calibrator for the candidate device.

Ask a specific question about this device

The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. 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 LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

This FDA document describes the clearance of the LIASYS 600 Electrolyte Measurement System and LIASYS 600 Creatinine reagent. It does not contain information about acceptance criteria or specific study results that proves the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter, which affirms substantial equivalence rather than detailing performance acceptance criteria and study findings.

Ask a specific question about this device

Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).

Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.

The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.

Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.

Here's the breakdown of the information that is applicable from your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.

Ask a specific question about this device

The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the Stat-Sensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary. venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

The Nova StatSensor Creatinine Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The Nova StatSensor Creatinine Hospital Meter System is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, the meter stores patient test data, QC test data, and other information relating to patient sample, operator, reagents, and the meter. A user interface provides a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

The document describes the Nova StatSensor Creatinine Hospital Meter System, which is intended for quantitative measurement of creatinine in whole blood.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance data from a study. Instead, it describes the device and states that its performance characteristics (measuring range, sample type, measuring technology, operating principle, analysis time, sample volume, sample application, meter calibration, controls, linearity solutions, and test strip reagents) are the "Same as Predicate" device (K070068).

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed new clinical study results for acceptance criteria. The claim of "Same as Predicate" for performance implies that the predicate device's acceptance criteria and performance data are being relied upon, but these are not explicitly listed or provided for the proposed device in this document.

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

This information is not provided in the document. The document states that "No changes have been made to Nova StatSensor Creatinine Test Strips and they are not a subject of this submission," and similar for control and linearity solutions. It also states the proposed device uses "the exact same technology, functionality, analytical and operational performance characteristics, as the predicate." This suggests that new analytical or clinical studies for the performance of the device were not conducted as part of this submission for the proposed device, as it is claiming equivalence based on unchanged performance characteristics.

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

This information is not provided. As explained above, no new performance study data (and thus no ground truth establishment process for such a study) is detailed in this 510(k) summary.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI components in this device description. The device is a "Creatinine Hospital Meter System" which measures creatinine directly from a blood sample using electrochemical biosensor test strips. It is not an AI-assisted diagnostic imaging or interpretation device.

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

This is not applicable. The device is a point-of-care meter system, not an algorithm. Its performance is inherent in the meter and test strip system.

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

This information is not provided for the proposed device. For a creatinine test system, the "ground truth" for analytical performance studies would typically be established by validated reference methods (e.g., laboratory-based creatinine assays with established accuracy and precision). However, as noted, new performance study data is not detailed here.

8. The sample size for the training set

This information is not provided. The document is not about a machine learning or AI algorithm that would typically involve a "training set."

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

This information is not provided and is not applicable to this type of device.

Summary of what is provided and what is missing:

• Acceptance Criteria/Performance: The document states the proposed device has the "Same as Predicate" performance characteristics, including measuring range, acceptable samples, measuring technology, operating principle, analysis time, sample volume, and meter calibration. However, the specific quantitative acceptance criteria and detailed performance data (e.g., accuracy, precision) are not explicitly listed for either the predicate or the proposed device in this summary.
• Studies: The document acts as a 510(k) summary to establish substantial equivalence for a modified device (ergonomic design changes) to an existing predicate. It asserts that the modified device uses the "exact same technology, functionality, analytical and operational performance characteristics" as the predicate. Therefore, it does not detail new analytical or clinical studies to demonstrate performance because it relies on the predicate's established performance.
• Specifics (Sample Size, Experts, Adjudication, Ground Truth, AI, MRMC): None of these details are available in the provided text, as the submission focuses on claiming equivalence rather than detailing new performance studies.

Ask a specific question about this device