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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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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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The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.

Not Found

This document describes the regulatory submission for a diagnostic device, not an AI/ML powered device. As such, concepts like "AI vs without AI assistance," "standalone performance," or "training set" are not applicable. The information provided focuses on the analytical performance of the Creatinine (Enzymatic) assay and its substantial equivalence to a predicate device.

Here's an analysis of the provided text based on the request, reinterpreting some terms for a diagnostic assay where appropriate:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "CV must be <= X%"). Instead, the performance is demonstrated through comparison with a predicate device and presentation of precision and method comparison data. The implied acceptance criterion for these studies is "comparable to the predicate device" or "within acceptable analytical variability."

2. Sample Sizes used for the Test Set and the Data Provenance

• Precision Studies: The document provides various "levels" (concentrations) for serum/plasma and urine. Each level typically has multiple measurements to calculate SD and CV. The exact number of individual samples/patients for precision studies is not explicitly stated, but it's common practice to use control materials or pooled patient samples across multiple runs.
• Method Comparison Studies:
  • Serum: N = 41 samples
  • Plasma: N = 52 samples
  • Urine: N = 135 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's a submission by "Thermo Fisher Scientific Oy" from "Vantaa, Finland," it's highly probable the studies were conducted in Finland or at least led by the Finnish branch. Standard analytical validation studies are typically prospective tests on collected samples.

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

This is an analytical device for measuring creatinine concentration, not an imaging or diagnostic AI device that requires expert interpretation. The "ground truth" for the test set is established by:

• Reference Methods: The predicate device (Roche/Hitachi 917 analyzer) is used as the comparative "reference" in the method comparison studies.
• Traceability/Standardization: The device's calibration is traceable to NIST SRM 967 (for serum) and NIST SRM 914a (for urine), which are primary reference materials.
• Known Concentrations: For precision studies, control materials or spiked samples with known creatinine concentrations are used.

Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation is not relevant here. The ground truth is analytical and based on established reference methods and standards.

4. Adjudication method for the test set

Not applicable for an analytical assay. Adjudication is typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies.

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 (IVD) assay, not an AI or imaging device with human reader interaction.

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

Yes, the performance data presented (precision, method comparison, measuring range, limitations) represents the standalone performance of the CREATININE (Enzymatic) assay system (reagent + T60 instrument). There is no "human-in-the-loop" performance component beyond sample handling and instrument operation, which is standard for IVD assays.

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

The ground truth for this device is based on:

• Reference Measurement Procedures: Comparison against a legally marketed predicate device (Roche/Hitachi 917 analyzer) which itself has established accuracy.
• Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM 967 for serum, SRM 914a for urine), which provide certified concentrations.
• Known Spiked Concentrations: For certain studies like interference testing, known concentrations of interfering substances are added.

Essentially, the ground truth is analytical accuracy and precision relative to established standards and methods.

8. The sample size for the training set

Not applicable in the context of this traditional IVD assay. There is no "training set" for an algorithm. The assay is a chemical reaction measured by an instrument.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" (analytical accuracy) for the device's development would have been established through rigorous chemical and analytical procedures, calibration with reference materials, and verification against known samples during product development.

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The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

CKMB Verifier is a lyophilized human serum base product. Level 1 contains no CKMB, Levels 2 and 3 contain CKMB from a simian heart source. The kit consists of six vials, two vials per level. The volume per vial is 1.0 mL.

The provided text describes a 510(k) submission for the Dimension® Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27). This product is a calibrator material used for verifying the CKMB method on Dimension® and Dimension Vista™ clinical chemistry systems.

It's crucial to understand that this submission is for a calibrator material, not a diagnostic device that directly measures a patient's CKMB levels or diagnoses a condition. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the verifier itself in its intended role of QC/calibration, not the diagnostic accuracy of a clinical test. The study described focuses on demonstrating substantial equivalence to a predicate device, and the specifics around clinical performance (e.g., sensitivity, specificity, accuracy against a gold standard in patient samples) are not applicable or detailed for a calibrator.

Based on the provided information, here's an attempt to answer your questions:

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

The document does not explicitly state quantitative acceptance criteria or a direct "performance" study in the sense of a diagnostic device. The primary "performance" aspect highlighted is its substantial equivalence to a previously cleared device (K863840) with an expanded intended use. For calibrators, performance is typically tied to stability, homogeneity, and its ability to act as a stable reference for the assay.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" or a quantified sample size for a performance study in the way one would for a diagnostic device. The assessment is based on the characteristics of the calibrator material itself and its comparison to the predicate device. Therefore, details about data provenance (country, retrospective/prospective) are not provided as it's not a clinical data-driven submission in that sense.

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

Not applicable. For a calibrator material, "ground truth" doesn't involve clinical expert consensus. Its value is established through manufacturing processes, analytical testing, and traceability to reference methods or standards, usually by the manufacturer's own qualified personnel using established laboratory practices.

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

Not applicable. No expert adjudication method is described as this is not a diagnostic device relying on interpretation of clinical data.

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

Not applicable. This device is a calibrator material, not an AI-powered diagnostic tool, and involves no human interpretation of images or clinical cases.

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

Not applicable. This is a physical calibrator material, not an algorithm.

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

For a calibrator like the CKMB Verifier, the "ground truth" or reference values are established through:

• Analytical methods and certified reference materials: The concentrations of CKMB in the verifier levels are determined by rigorous analytical testing using validated methods and, ideally, traceable to established reference materials or methods.
• Manufacturer's internal quality control and validation: The manufacturer performs extensive testing to ensure the lot-to-lot consistency, stability, and assigned values of the calibrator material.

8. The sample size for the training set

Not applicable. There is no training set as described for an AI/algorithm-based device.

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

Not applicable. There is no training set for this type of device.

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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 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.

This submission describes the Abbott Laboratories Creatinine assay. This is an in vitro diagnostic assay used for the quantitative analysis of creatinine in human serum, plasma, or urine and is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer.

1. Acceptance Criteria and Device Performance

Note: The acceptance criteria are "implied" as the document primarily focuses on demonstrating substantial equivalence to the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by showing comparable performance characteristics rather than specifying explicit numeric thresholds for the Abbott device to meet independently.

2. Sample Size and Data Provenance (Test Set)

• Sample Size: Not explicitly stated for specific test sets in correlation or precision studies. The document refers to "comparative performance studies" and "precision studies." No specific number of patient samples or replicates is provided.
• Data Provenance: Not specified. It is likely that the data was generated internally by Abbott Laboratories during the development and validation of the assay, but the country of origin or whether it was retrospective or prospective is not mentioned.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Not applicable. This is an in vitro diagnostic assay for creatinine measurement, not an imaging device or a diagnostic algorithm requiring expert interpretation of complex data for ground truth establishment. The ground truth for this type of device is typically established by comparing its measurements to a legally marketed predicate device (as done here) or to a recognized reference method.

4. Adjudication Method (Test Set)

Not applicable. As described above, this is an in vitro diagnostic assay and does not involve human interpretation or adjudication processes for its test set.

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

Not applicable. This is an in vitro diagnostic assay, not a device designed to assist human readers in interpreting medical images or other findings where an MRMC study would be relevant.

6. Standalone Performance Study

Yes, standalone performance studies were conducted to evaluate the Abbott Creatinine assay on the AEROSET and ARCHITECT c8000 Systems.

• Correlation Studies: Demonstrated the assay's performance against the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by reporting correlation coefficients, slopes, and Y-intercepts.
• Precision Studies: Evaluated the reproducibility of the assay by reporting total %CV at different concentration levels.
• Linearity Studies: Established the range over which the assay provides accurate measurements.
• Limit of Quantitation (Sensitivity): Determined the lowest concentration that can be reliably measured.

These studies assess the algorithm's (or assay's) performance independently of human intervention.

7. Type of Ground Truth Used

The ground truth or reference standard for the comparative performance studies was the Roche Creatinine assay on the Hitachi 917 Analyzer (K941837), which is a legally marketed predicate device. For precision, linearity, and sensitivity, the ground truth would be expected values from reference materials or defined concentration levels.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay based on a chemical reaction (modified Jaffe method), not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of such assays involves method development, optimization, and calibration using reference materials and quality controls.

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

Not applicable, as this device does not utilize a "training set" in the context of AI/machine learning. The assay's chemical principles and performance are established through laboratory experimentation, calibration using known standards, and validation studies.

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The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or 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.

The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Creatinine LiquiColor® device:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, explicit acceptance criteria for novel performance claims. However, the performance data presented implicitly sets the "acceptance criteria" by showing performance comparable to the predicate device and within generally accepted analytical limits for clinical assays.

Here's a table summarizing the reported performance, with the understanding that these values, by virtue of leading to substantial equivalence, implicitly served as the 'acceptance criteria' for this submission.

| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-|
| Method Comparison (Correlation with Predicate) | Serum: Correlation coefficient (r) ≥ ~0.99 (based on observed 0.9991) Regression slope (y) ≈ 1.0 (based on observed 1.4815x - 0.5831, acknowledging a notable slope difference, but still showing strong correlation). | Serum: r = 0.9991, regression equation: y = 1.4815x - 0.5831 |
| | Urine: Correlation coefficient (r) ≥ ~0.98 (based on observed 0.9854) Regression slope (y) ≈ 1.0 (based on observed 1.0545x + 0.3607, showing good agreement). | Urine: r = 0.9854, regression equation: y = 1.0545x + 0.3607 |
| Precision (Intra-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Intra-Assay: 0.610 mg/dL: CV% = 1.14%; 1.107 mg/dL: CV% = 0.84%; 5.733 mg/dL: CV% = 0.41% |
| Precision (Inter-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Inter-Assay: 0.629 mg/dL: CV% = 1.98%; 1.134 mg/dL: CV% = 0.98%; 5.814 mg/dL: CV% = 0.38% |
| Sensitivity | Low detection limit, clinically relevant (e.g., < 0.1 mg/dL for creatinine). | 0.04 mg/dL (based on instrument resolution A = 0.001) |
| Linearity | Wide linear range, covering clinically relevant creatinine concentrations (e.g., up to 200 mg/dL for severe renal impairment). | Linear to 200 mg/dL |

Note on "Acceptance Criteria": As this is a 510(k) summary, formal, explicit "acceptance criteria" (e.g., "The device must achieve an R-squared of X or greater compared to the predicate") are not typically stated in the summary itself. The demonstration of "Substantial Equivalence" inherently means that the device's performance, as measured by these studies, met the FDA's unwritten (or, in some cases, guidance-specified) expectations for equivalence to the predicate. The reported values are the results that led to this determination.

Study Details

The provided text describes analytical studies to demonstrate "substantial equivalence" of the Creatinine LiquiColor® test to a predicate device (Roche Diagnostics Creatinine reagent, 510(k) K941837).

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Serum: n = 30 specimens
   • Urine: n = 37 specimens
   • Data Provenance: Not explicitly stated (e.g., country of origin, demographics of sample donors). It is, however, implied to be a prospective collection of patient samples for comparison testing, as common in method comparison studies. It is not specified if these were "retrospective" (archived samples) or "prospective" (newly collected for the study).

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

   • Not applicable. This device is a quantitative clinical chemistry assay. The "ground truth" for the test set is established by the predicate device's measurement (Roche Diagnostics Creatinine reagent), not by expert opinion. The study aims to show correlation between the new device's measurements and the predicate's measurements. There is no mention of experts establishing a "ground truth" in terms of diagnosis or interpretation.

3. Adjudication Method:

   • Not applicable. As described above, the study compares quantitative measurements from two different analytical methods. There is no diagnostic endpoint requiring adjudication by experts.

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

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases. This device is a quantitative in vitro diagnostic assay.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the performance data presented (Correlation, Precision, Sensitivity, Linearity) represents the standalone performance of the Creatinine LiquiColor® enzymatic assay. There is no human interpretation component in the measurement or result generation for this type of IVD, so the "algorithm only" performance is the only performance. The device provides a quantitative creatinine value without human interpretation required for the numerical result itself.

6. Type of Ground Truth Used:

   • Predicate Device Measurements: The "ground truth" in this context is the quantitative creatinine concentration determined by the predicate device (Roche Diagnostics Creatinine reagent). The study aims to demonstrate that the new device's results are in agreement with these "ground truth" values established by the already-approved predicate method.

7. Sample Size for the Training Set:

   • Not applicable. This device is an enzymatic chemical assay, not a machine learning or AI algorithm in the contemporary sense that would require a "training set." The methodology is based on established biochemical reactions rather than learned patterns from data.

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

   • Not applicable, as there is no "training set" for this type of device. The assay's mechanism is defined by the chemical reactions rather than statistical learning from data.

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Mission Creatinine Reagent Kit is for the quantitative determination of creatinine in serum, plasma, or urine on the Beckman Synchron CX® & CX® Delta Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in renal dialysis, and as a calculation basis for measuring other urine analytes.

Creatinine is determined by mixing a sample with the alkaline picric reagent, Creatinine from the sample combines with the reagent to produce a red-colored complex. Absorbance readings are taken at both 520 nm and 560 nm at 25.6 seconds after sample addition. The differential absorbance is a direct measure of the concentration of Creatinine in the sample.

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific questions:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the specified guidelines (NCCLS EP5-A and EP9-A2). The "acceptance" is demonstrated by the Mission Creatinine Reagent exhibiting "similar" performance characteristics to the Beckman Creatinine Reagent.

Study Details

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

• Precision:
  • Sample Size: 80 for each control (Serum Control 1, Serum Control 2, Urine Control 1, Urine Control 2). Total of 320 observations.
  • Data Provenance: Not explicitly stated, but clinical laboratory controls are typically pooled human or synthetic samples. The study was conducted following NCCLS Guideline EP5-A. Likely prospective, as samples were run over 20 days.
• Method Comparison:
  • Serum: n = 71 samples (serum samples were spiked or diluted).
  • Urine: n = 45 samples (urine controls were spiked or diluted).
  • Data Provenance: Not explicitly stated, but the comparison involves running samples with both the Mission and Beckman reagents simultaneously. Likely prospective, generated for this study.
• Recovery to Expected Values:
  • Serum: Varying dilutions from a high of 9.04 mg/dL to a low of 0.20 mg/dL. The number of samples/dilutions isn't a single 'n' but represents a range of tested concentrations.
  • Urine: Varying dilutions from 400 mg/dL to 10 mg/dL.
  • Data Provenance: Not explicitly stated, but involved spiking and diluting pooled serum and urine controls. Likely prospective, generated for this study.
• Functional Sensitivity:
  • Sample Size: Each dilution was tested as 4 samples per run over 5 calibrated runs. For the 0.90 mg/dL expected value, N=20; for 0.30 mg/dL, N=20; for 0.18 mg/dL, N=20; for 0.04 mg/dL, N=5 (Mission) and N=2 (Beckman); for 0.00 mg/dL, N=9 (Mission) and N=11 (Beckman).
  • Data Provenance: Dilutions of serum samples and a zero. Likely prospective, generated for this study.

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

This information is not applicable as the device is an in-vitro diagnostic (IVD) reagent for quantitative chemical analysis. Ground truth is established by the known concentration of controls/spiked samples or by comparison to a legally marketed predicate device, not by expert interpretation.

4. Adjudication method for the test set

This information is not applicable for this type of IVD device. Adjudication is relevant for scenarios involving human interpretation, often clinical or imaging diagnosis, where discrepancies between readers or between reader and ground truth need to be resolved. For quantitative chemical measurements, the output is a numerical value which is then compared against known values or a predicate.

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

This information is not applicable. This is an IVD reagent, not an AI-assisted diagnostic tool that involves human readers.

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

This is an IVD reagent, so the "device" (reagent) operates standalone in conjunction with the analytical instrument (Beckman Synchron CX & CX Delta Systems). The performance data presented (precision, correlation, recovery, functional sensitivity) inherently represents the standalone performance of the reagent on the specified instrument.

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

The ground truth for this device's performance evaluation was established using:

• Known concentrations: For control materials (serum/urine controls) used in precision studies.
• Expected values: For spiked or diluted samples in method comparison and recovery studies. Creatinine was added gravimetrically for some recovery samples.
• Predicate Device: The Beckman Creatinine Reagent served as the reference standard against which the Mission Reagent's performance was compared for correlation, recovery, and functional sensitivity. The premise is that the predicate device is already recognized as providing accurate measurements.

8. The sample size for the training set

This information is not applicable. This is a chemical reagent, not a machine learning model, so there is no "training set" in the computational sense. The "development" of the reagent would involve chemical formulation and optimization, not data-driven machine learning training.

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

This information is not applicable for the same reasons as point 8.

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