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The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.

The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of gentamicin in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided text describes a 510(k) submission for the ARCHITECT iGentamicin assay and its calibrators. It outlines the intended use, device description, and a summary of analytical performance studies conducted to demonstrate substantial equivalence to a legally marketed predicate device (AxSYM Gentamicin). However, it does not contain specific acceptance criteria values or detailed results of the studies in a manner that would allow for the construction of the requested table and comprehensive answers to all questions.

Here's an attempt to answer based on the available information, with significant limitations due to the missing data:

Acceptance Criteria and Device Performance

The document states that the ARCHITECT iGentamicin assay is "substantially equivalent to the AxSYM Gentamicin assay in terms of analytical performance data in this 510(k) submission." This implies that the acceptance criteria for each validation study would have been defined to demonstrate this equivalence, likely by showing that the performance of the new device is within predefined statistical limits compared to the predicate. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given text. The text only lists the types of studies performed (e.g., Precision, Linearity, Method Comparison).

Study Details Based on Available Information:

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

   • Cannot be fully constructed as the specific numerical acceptance criteria and reported performance values are not provided in the input text. The text only lists the types of studies performed without their results or target specifications.

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

   • Not specified in the provided text. The document lists "Method Comparison (Correlation)" as one of the studies, which would typically involve a test set of patient samples. However, details on sample size, origin, or retrospective/prospective nature are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable/Not specified. This device is an in vitro diagnostic (IVD) assay for quantitative determination of gentamicin. Ground truth for such assays is typically established through a reference method or validated analytical techniques, not by expert consensus (e.g., radiologists interpreting images). The text does not mention expert involvement in establishing ground truth for the analytical performance studies.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies where subjective interpretation (e.g., image reading) is involved. For an IVD assay's analytical performance, the "ground truth" (or reference values) for samples are typically determined by highly accurate and precise analytical methods, not through an adjudication process involving multiple human experts.

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 submission is for an in vitro diagnostic (IVD) reagent kit and calibrator, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant to this submission.

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

   • Yes, implicitly. The ARCHITECT iGentamicin assay, as an automated chemiluminescent microparticle immunoassay (CMIA), operates as a standalone analytical system to produce quantitative results. Its "performance" refers to the accuracy, precision, linearity, and other analytical characteristics of the assay itself, independent of human interpretation or assistance beyond operating the instrument and processing samples. The "Summary of Analytical Performance" directly addresses its standalone performance.

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

   • For the "Method Comparison (Correlation)" study, the "ground truth" would be the results obtained from the legally marketed predicate device, AxSYM Gentamicin assay, or a recognized reference method. The study would aim to demonstrate correlation and agreement between the new device's results and this established reference. For other analytical studies (Precision, Linearity), the "ground truth" is derived from known concentrations of analytes in control materials or reference standards.

8. The sample size for the training set:

   • Not specified. As an IVD assay based on established chemical and immunological principles, it's unlikely that the "training set" in the sense of machine learning applies directly here. If "training" refers to method development and optimization, the sample sizes used for such internal studies are not detailed in this summary.

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

   • Not applicable in the context of machine learning training. If "training set" refers to samples used during assay development and optimization, the "ground truth" for these samples would typically be established using highly accurate and precise analytical methods, often a reference method or gravimetrically prepared standards with known concentrations. The specific details are not provided in this regulatory summary.

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The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Multigent® Gentamicin assay.

1. Table of Acceptance Criteria and Reported Device Performance:

Note regarding Rheumatoid Factor interference: The reported % Recovery (132.34%) for Rheumatoid Factor at 582 IU exceeds the stated acceptance criteria of 100 ± 10%. This indicates potential interference from high levels of Rheumatoid Factor, which should be noted in the device labeling.

2. Sample Size and Data Provenance:

• Accuracy: 5 samples (0.25, 1.00, 2.25, 4.50, 8.00 µg/mL) each run in triplicate (total of 15 measurements in the table shown). Data provenance not specified (retrospective/prospective, country of origin).
• Linearity: 4 serially diluted samples (6.88, 5.16, 3.44, 1.72 MG/ML) each run in triplicate (total of 12 measurements in the table shown). Data provenance not specified.
• Precision: 3 control levels (low, mid, high) tested, with N=80 for each (number of replicates over time). Data provenance not specified.
• Sensitivity: Calibrator A (0 µg/mL) run for a total of 20 replicates. Data provenance not specified.
• Interferences (Endogenous Substances):
  • Bilirubin: 3 replicates for "N=3" (interpreted as the number of independent samples or measurement replicates, as the "N" column is inconsistent).
  • Hemoglobin: 2 replicates for "N=2".
  • Triglyceride, Total Protein: "N" is listed as a non-numeric character (presumably an error in transcription, but the text mentions "run in triplicate" for triglyceride and total protein).
  • Rheumatoid Factor: "N" is listed as a non-numeric character (text mentions "run in triplicate").
  • Data provenance not specified.
• Interferences (HAMA): Duplicate HAMA samples (Type-1 and Type-2) and duplicate control samples. Data provenance not specified.
• Interferences (Common Co-Administered Drugs): Test samples and control samples assayed in duplicate for each drug. Data provenance not specified.
• Anticoagulants: Blood drawn from at least ten healthy donors for each of the 9 tube types. Samples were spiked with Gentamicin and run in duplicate. Data provenance not specified.
• Method Comparison: 55 serum and plasma samples, ranging from 0.78 to 9.02 µg/mL Gentamicin. Data provenance not specified.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" for chemical concentration assays is typically established by reference methods, primary standards, or gravimetric/volumetric preparation of known concentrations. There is no mention of human "experts" establishing ground truth in the traditional sense of clinical opinion (e.g., radiologists, pathologists). The ground truth for performance studies like accuracy and linearity is based on the theoretical concentrations of prepared samples or reference materials. For method comparison, the predicate device (Abbott TDx®/TDxFLx® Gentamicin assay) serves as the reference method.

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

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., image interpretation) where multiple readers provide independent evaluations that might conflict. For quantitative chemical assays, the result is a numerical value, and "adjudication" is not a standard practice. Statistical methods are used to compare results to expected values or reference methods.

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

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

The performance studies described (Precision, Accuracy, Linearity, Sensitivity, etc.) represent the standalone performance of the Multigent® Gentamicin assay system. The device itself generates a quantitative result without direct human interpretation of a visual output. The human-in-the-loop would be the laboratory personnel operating the Architect C8000 System and interpreting the numerical result in a clinical context.

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

The ground truth for this device's performance relies on:

• Theoretical Concentrations: For accuracy, linearity, and sensitivity studies, known concentrations of Gentamicin in control matrices serve as the ground truth. These are typically prepared using gravimetric or volumetric methods with highly pure reference standards.
• Reference Method: For the method comparison study, the Abbott TDx®/TDxFLx® Gentamicin assay served as the reference (or comparative) method, with its results considered the "ground truth" for evaluating the new device's correlation.

8. The sample size for the training set:

Not applicable. This device is a chemical immunoassay, not a machine learning or artificial intelligence system that requires a "training set" in the computational sense. The assay works based on established biochemical principles and reagents rather than being "trained" on data.

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

Not applicable, as there is no training set for this type of in vitro diagnostic device.

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1. For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
3. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin. VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters. VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

This document describes the VITROS Chemistry Products GENT Reagent, VITROS Chemistry Products Calibrator Kit 13, and VITROS Chemistry Products TDM Performance Verifiers I, II, and III used to quantitatively measure gentamicin (GENT) concentrations.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent to the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) based on the correlation and analytical performance studies. The primary acceptance criterion for the GENT assay is its strong correlation with the predicate device.

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

• The document states that "patient samples" were used for the equivalence study. However, the exact sample size of the test set is not specified.
• The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.

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

• This information is not provided in the document. For in-vitro diagnostic devices like this, the "ground truth" is typically established by comparative analysis with an established, legally marketed predicate device, or by reference methods, rather than expert consensus on patient images or clinical assessments.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation involves comparing quantitative measurements from the new device against a predicate device, rather than expert adjudication of qualitative judgments.

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

• A MRMC comparative effectiveness study was not performed as this device is an in-vitro diagnostic assay, not an imaging device that would typically involve human readers interpreting results. The comparison is between the new assay and a predicate assay.

6. Standalone (Algorithm Only) Performance Study

• This description refers to the device's performance as a standalone assay. The study cited (correlation with predicate device, precision, expected values, linearity, and specificity studies) falls under this category of standalone analytical performance. The device is designed to operate autonomously with the VITROS 5,1 FS Chemistry System.

7. Type of Ground Truth Used

• The ground truth for the equivalence study was established by the measurements obtained from the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) using the same "patient samples." Additionally, the product's instructions for use refer to studies on precision, expected values, linearity, and specificity, which would use established analytical methods or reference materials to determine ground truth.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for an in-vitro diagnostic assay, not an AI/ML-driven device that typically requires a distinct "training set." Therefore, information regarding a specific training set size is not applicable and not provided. The development process for such assays involves internal studies (e.g., reagent optimization, calibration curve development) that are not typically referred to as "training sets" in the context of these submissions.

9. How Ground Truth for the Training Set Was Established

• As noted in point 8, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to this type of device and submission. The analytical performance (e.g., linearity, precision) is established through rigorous laboratory experiments using reference materials and spiked samples with known concentrations, or comparison to established methods.

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The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.

The Roche ONLINE Gentamicin Assay is an in vitro diagnostic reagent system designed for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. The device is used to diagnose and treat gentamicin overdose and monitor drug levels for appropriate therapy.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a formal table with pass/fail thresholds. Instead, it presents performance characteristics (precision and method comparison) of the new device and compares them to a legally marketed predicate device (COBAS INTEGRA Gentamicin Assay). The statement "All of the evaluation studies gave acceptable results compared to the predicate device" implies that the new device's performance characteristics were deemed equivalent to those of the predicate.

Below is a table summarizing the reported device performance, with the implicit acceptance criteria being performance comparable to the predicate device.

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

• Sample Size for Test Set:
  • For the method comparison study comparing the Roche/Hitachi 917 to the COBAS INTEGRA 700 (new device vs. predicate), the sample size was N = 112.
  • For the comparison of the predicate device (COBAS INTEBRA Gentamicin) to COBAS FARA II Gentamicin assay, the sample size was N = 145. This appears to be a historical comparison for the predicate, not directly reflecting the current test set for the new device.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It is implied to be data collected specifically for this 510(k) submission, likely prospective, given the nature of performance evaluation studies for new devices.

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

This type of information is not applicable to this device. The Roche ONLINE Gentamicin Assay is an in vitro diagnostic device that quantifies a drug concentration in biological samples. The "ground truth" for its performance is established by comparison to a reference method or a legally marketed predicate device, and through analytical performance characteristics like precision, not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and discrepancies need to be resolved. This device performs a quantitative chemical analysis, not interpretation.

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 is not applicable to this device. MRMC studies are relevant for AI-powered diagnostic tools that assist human readers in tasks like image interpretation. The Roche ONLINE Gentamicin Assay is a laboratory assay for drug concentration measurement and does not involve human readers for interpretation in this context, nor does it use AI.

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

Yes, a standalone performance study was conducted. The entire evaluation, including method comparison and precision, assesses the performance of the device (reagent system on an automated analyzer) without human intervention in the analytical process itself. The numbers reported (e.g., correlation coefficient, CV%) directly reflect the algorithm/assay's performance.

7. The Type of Ground Truth Used

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

• Comparison to a Legally Marketed Predicate Device: The Roche ONLINE Gentamicin Assay was compared to the COBAS INTEGRA Gentamicin Assay, which serves as a recognized standard in the market. The predicate's results are considered the comparative "truth" or reference.
• Analytical Performance Metrics: Intrinsic analytical performance characteristics such as precision (within-run and total CV%) are fundamental to establishing the reliability and "truthfulness" of the measurements.

8. The Sample Size for the Training Set

This is not applicable to this device in the context of an AI/machine learning training set. The Roche ONLINE Gentamicin Assay is a chemical assay, not an AI or machine learning algorithm that requires a "training set." Its calibration involves calibrator materials with known concentrations, but this is a standard chemical assay procedure, not an AI training process.

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

This is not applicable for the same reasons as point 8. The "ground truth" for calibration in a chemical assay is established through the gravimetric preparation of calibrators with certified concentrations or by comparison to definitive reference methods.

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The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and are for use by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.

The provided text is related to a 510(k) premarket notification for a Gentamicin Test Kit. It includes the FDA's letter of substantial equivalence and the indications for use. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided document.

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For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.

IMMULITE® 2000 Gentamicin is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.

Acceptance Criteria and Study for IMMULITE® 2000 Gentamicin

The IMMULITE® 2000 Gentamicin device's performance was evaluated by comparing it to a predicate device, the Abbott AxSYM® Gentamicin. The acceptance criteria essentially revolved around demonstrating substantial equivalence in measuring gentamicin concentrations in human specimens.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined quantitative acceptance criteria. The "Acceptance Criteria (Implied by Comparison)" are inferred from the typical standards for demonstrating substantial equivalence against a predicate device in method comparison studies.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 89 patient samples.
• Data Provenance: Not explicitly stated, but based on the nature of the device (in vitro diagnostic for monitoring drug levels in human specimens), it is prospective, collected from patients. The country of origin is not specified, but the manufacturer is based in the USA.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for the test set was established by the predicate device (Abbott AxSYM® Gentamicin), not through expert consensus.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: None. The comparison was directly between the IMMULITE® 2000 and the predicate device's measurements for each sample.

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

• MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or diagnostic interpretation device that typically involves human readers.

6. Standalone Performance Study

• Standalone Performance Study: Yes, in the sense that the IMMULITE® 2000 Gentamicin's measurements were observed independently. However, its performance was evaluated and understood in the context of comparison to the predicate device. The results (linear regression, correlation coefficient, means) represent the standalone performance relative to a reference.

7. Type of Ground Truth Used

• Type of Ground Truth: Measurements from a legally marketed and accepted predicate device (Abbott AxSYM® Gentamicin).

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a separate "training set" in the context of an AI/machine learning model. The IMMULITE® 2000 Gentamicin is a chemiluminescent immunoassay, a chemical assay, not an AI-powered algorithm that requires a training set in the typical sense. Its calibration would rely on reference standards rather than a "training set" of patient data.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this is a chemical immunoassay, not an AI algorithm. Calibration and quality control for such assays typically involve known concentrations of gentamicin standards, which serve as the reference for accurate measurement.

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The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The GENT method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody.

This document describes a 510(k) submission for the Gentamicin FLEX™ Reagent Cartridge. The information provided is for a chemical assay for an in vitro diagnostic device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI validation (e.g., sample size for AI, ground truth establishment, MRMC studies, expert qualifications) are not applicable or cannot be answered from the provided text.

Here's the information that can be extracted or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states the GENT FLEX™ reagent cartridge is "substantially equivalent to the Abbott AxSYM® Gentamicin assay." Substantial equivalence is the primary acceptance criterion for 510(k) devices. This is demonstrated by comparing performance metrics, specifically method comparison data.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 197 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, for an in vitro diagnostic assay, these would typically be human serum or plasma samples. The context suggests these were likely clinical or spiked samples used in a laboratory setting for method comparison. It does not specify if they are retrospective or prospective.

3. Number/Qualifications of Experts for Ground Truth

• Not Applicable. For a chemical assay demonstrating substantial equivalence, "ground truth" is established by the performance of the predicate device (Abbott AxSYM® Gentamicin assay) and clinical utility for measuring gentamicin. There are no "experts" establishing a diagnostic ground truth in the sense of image interpretation.

4. Adjudication Method

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretations (e.g., radiology, pathology) to resolve discrepancies. This is a method comparison study for an analytical measurement.

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

• No. This is not relevant for a chemical assay. MRMC studies are used to assess human reader performance, often in diagnostic imaging, with and without AI assistance. This device is not an AI.

6. Standalone Performance Study

• Yes (in an analytical sense). The study presents the standalone analytical performance of the GENT FLEX™ reagent cartridge by comparing its results to a predicate device. The device's performance (slope, intercept, correlation coefficient) is reported as measured directly. This is an "algorithm only" type of performance, where the "algorithm" is the PETINIA technique.

7. Type of Ground Truth Used

• Comparative Reference Method: The "ground truth" for this study is effectively the results obtained from the Abbott AxSYM® Gentamicin assay, which serves as the predicate device. The study aims to demonstrate that the new device yields comparable results to an already FDA-cleared method.

8. Sample Size for Training Set

• Not Applicable. This is not an AI/ML device that requires a distinct "training set." The development of the assay (reagent formulation, calibration) would involve internal R&D, but there isn't a specified "training set" in the context of AI model development.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As above, there's no concept of a "training set" ground truth in the AI sense for this type of device. The assay development would rely on analytical chemistry principles and internal method validation.

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an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.

modified Emit® 2000 Gentamicin Assay, an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.

Here's an analysis of the provided text in the context of device acceptance criteria and a supporting study:

The provided document describes the Emit® 2000 Gentamicin Assay and Emit® 2000 Gentamicin Calibrators, an in vitro diagnostic reagent test kit. The study aims to demonstrate substantial equivalence to a predicate device, the Abbott TDx Gentamicin Assay (K904226).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as clear pass/fail thresholds. Instead, it presents performance metrics and implies that these values demonstrate substantial equivalence to the predicate device. Therefore, I will create a table based on the reported precision and accuracy for the Emit® 2000 Gentamicin Assay.

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

• Test Set Sample Size: 104 patient samples were evaluated for accuracy.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "patient samples," which implies human subjects. The study is prospective in the sense that the samples were analyzed with the Emit 2000 Gentamicin Assay to compare against the predicate, but it doesn't specify if these were newly collected samples specifically for the study or retrospectively collected. The term "patient samples" often implies retrospectively collected samples from a clinical setting, but this is not explicitly stated.

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

This study does not involve human experts establishing a "ground truth" in the typical sense (e.g., radiologists interpreting images). The ground truth for this comparative accuracy study is the results from the predicate device (Abbott TDx Gentamicin Assay), which is itself an analytical device. Therefore, the concepts of "number of experts" and "qualifications of experts" are not applicable here.

4. Adjudication Method for the Test Set

Not applicable. There was no human interpretation or adjudication involved, as the comparison was between two analytical devices.

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 not an AI-assisted diagnostic study involving human readers. It's a comparison of two in vitro diagnostic assays.

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

Yes, a standalone performance assessment was conducted for the Emit® 2000 Gentamicin Assay, as described under "A. Within-Run and Total Precision" and "B. Accuracy." The device's performance was evaluated based on its own output against established reference methods (for precision) or the predicate device (for accuracy). There is no "human-in-the-loop" component in the operation or result generation of these assays.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study was the results obtained from the predicate device, the Abbott TDx Gentamicin Assay (FPIA). For the precision study, commercial controls with known analyte levels would serve as a form of "ground truth" or reference material.

8. The Sample Size for the Training Set

Not applicable. This is an analytical immunoassay kit, not a machine learning model that requires a training set. The "development" and "calibration" process for such a kit involves different methodologies.

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

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

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