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The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only.

The Diazyme Ferritin Calibrator Set is intended for use in the Diazyme Ferritin Assay. For in vitro diagnostic use only.

The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.

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The provided text describes a 510(k) premarket notification for a medical device, the Diazyme Ferritin Assay. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and general regulatory information.

The document does NOT contain information about acceptance criteria, device performance, an actual study proving device performance, sample sizes for test sets or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.

The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.

The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.

The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.

The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

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The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.

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The provided text is related to a 510(k) premarket notification for a medical device called the "RDI Ferritin Calibrator Set." This document is a letter from the FDA to the manufacturer, confirming substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a diagnostic or AI-based device.

The RDI Ferritin Calibrator Set is a calibrator, meaning it's used to establish a reference for quantitative measurements in a laboratory test (the RDI Ferritin Kit). Its performance is typically assessed by ensuring it produces consistent and accurate calibration curves, which in turn allows the associated assay (the RDI Ferritin Kit) to accurately measure ferritin levels.

Therefore, most of the questions you've asked, which are relevant to clinical studies validating the performance of a diagnostic or AI device (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and are not present in this document.

However, I can extract the relevant information from the document:

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

• Not applicable / Not provided in this document. This document is a regulatory approval letter, not a performance study report. The acceptance criteria for a calibrator would typically relate to its ability to accurately calibrate the assay it is designed for, ensuring linearity, precision, and stability. These specific criteria and their fulfillment are not detailed here.

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

• Not applicable / Not provided in this document. This document does not describe a clinical performance study using patient samples. Test sets as typically understood for diagnostic devices are not relevant here.

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 provided in this document. Ground truth, in the context of clinical device validation, refers to a definitive diagnosis or measurement. For a calibrator, "ground truth" would relate to the certified values of the calibrator itself, and its ability to correctly calibrate an assay, rather than a clinical expert consensus on patient data.

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

• Not applicable / Not provided in this document.

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 / Not provided in this document. This is a calibrator, not an AI-assisted diagnostic device.

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

• Not applicable / Not provided in this document. This is a physical calibrator set for an in vitro diagnostic assay, not a standalone algorithm.

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

• Not applicable / Not provided in this document. For a calibrator, the "ground truth" would be the assigned values of the calibrator materials themselves, which are established through a rigorous manufacturing and testing process to ensure accuracy and traceability to reference methods. This information is not in the FDA letter.

8. The sample size for the training set:

• Not applicable / Not provided in this document. This device is not an AI algorithm requiring a training set.

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

• Not applicable / Not provided in this document.

Summary of what is in the document:

• Device Name: RDI Ferritin Calibrator Set
• Intended Use: To establish points of reference for the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, for use with the RDI Ferritin Kit.
• Regulatory Status: Class II device, found substantially equivalent to legally marketed predicate devices.
• Product Code: JIT
• Approval Date: March 13, 2006

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Good Biotech Corp. (GBC) Ferritin LIT Assay is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism.

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only

Good Biotech Corp. Ferritin LIT Assay is a ready to use reagent for the quantitative determination of ferritin by latex particle enhanced immunoturbidimetry (LIT). Duck anti-ferritin IgY(ΔFc) is coupled to polystyrene microparticles, which greatly increase the analytical sensitivity. When ferritin of the sample encounters with the latex microparticles sensitized with duck anti-ferritin IgY(AFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the ferritin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual ferritin concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known ferritin concentrations.

This 510(k) submission describes the Ferritin LIT Assay, Ferritin Calibrator Set, and Ferritin Controls (Level-L & Level-H) developed by Good Biotech Corp. The purpose of the study was to demonstrate substantial equivalence to a predicate device, the Biokit quantex Ferritin system.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, a "high correlation coefficient" is an implicit acceptance criterion for demonstrating substantial equivalence based on comparative performance studies.

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

• Sample Size: 50 serum samples
• Data Provenance: Retrospective (clinical samples for comparative study). The country of origin is not specified but given the submitter is in Taiwan, it is likely the samples were sourced there.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantifying ferritin in human serum. The "ground truth" for comparative studies in IVD typically refers to the results obtained from a reference method (the predicate device in this case) rather than expert interpretation of images or other subjective data. No human experts were involved in establishing the "ground truth" in the way described for medical imaging devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used when subjective interpretations are involved, such as in clinical trials or medical imaging studies to resolve discrepancies among experts. This study involves quantitative measurements, where the "ground truth" is established by the predicate device's numerical output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess improvements in reader performance. This device is an automated IVD assay, not a device requiring human interpretation of complex data.

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

Yes, the performance study conducted was a standalone performance of the device. The Ferritin LIT Assay directly measures ferritin concentration in serum samples without human intervention in the measurement process (beyond sample handling and initiation of the automated analyzer). The comparison was between the new assay and the predicate device's measurements.

7. The Type of Ground Truth Used

The "ground truth" used for the comparative study was the results obtained from the predicate device (Biokit quantex Ferritin). This is a common practice in IVD substantial equivalence demonstrations, where the new device's performance is compared against an already legally marketed and accepted device.

8. The Sample Size for the Training Set

The document does not report a separate training set size. For IVD assays, development often involves internal optimization and calibration using various samples, but a formally defined "training set" in the context of machine learning or AI is not typically described in these types of 510(k) summaries unless the device incorporates such algorithms. The 50 serum samples mentioned were for the comparative performance study (test set).

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

Since a distinct "training set" (as typically defined in AI/ML contexts) is not described, the method for establishing its "ground truth" is not provided. For IVD assay development, calibration is typically performed using calibrators with known concentrations, and controls are used to verify performance within established ranges. The "GBC Ferritin Calibrator Set" and "GBC ferritin Controls" are mentioned as being used with the assay to establish the calibration curve and for quality control, respectively. These materials would have their "ground truth" concentrations established through rigorous analytical methods by the manufacturer.

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The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.

The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.

For in vitro diagnostic use.

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically an in-vitro diagnostic test. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain the acceptance criteria, study details, or performance data of the device.

The letter states that the FDA has reviewed the premarket notification, but it does not present the data from the studies that would have been submitted as part of that notification.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth details, MRMC study results, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate performance study report, which is not included here.

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The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and in the diagnosis and management of iron-related disorders such as hemochromatosis (iron overload) and iron deficiency anemia. The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay. For in vitro diagnostic use.

Not Found

This document, a 510(k) premarket notification, indicates FDA clearance for a device but does not contain detailed information about the acceptance criteria and the study that proves the device meets them. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone performance directly from the provided text. This information would typically be found in the device's documentation, such as a validation report or clinical study summary, which is not included here.

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The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The document describes the IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Calibrator. The core of the study reported is a comparison to a predicate device and an evaluation of the device's imprecision. The acceptance criteria are implicitly defined by the reported performance and the finding of "substantial equivalence" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the reported "good" performance metrics that led to substantial equivalence.

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

• Method Comparison Study:

  • Sample Size (n): 116 serum samples
  • Data Provenance: Not explicitly stated, but clinical samples (serum) would typically be from a patient population. It is not specified if they were retrospective or prospective, nor the country of origin.

• Imprecision Study:

  • Sample Size (N): 80 replicates for each of the three levels (240 total measurements).
  • Data Provenance: Not explicitly stated, but these would be internal laboratory samples or controls.

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

This type of in-vitro diagnostic device does not typically rely on "experts" in the same way an imaging or pathology device would for establishing ground truth.

• For the method comparison study, the "ground truth" for the test set was effectively the measurements obtained from the predicate device (Abbott IMx® Ferritin). Therefore, the "experts" were the established and validated methodology of the predicate device.
• For the imprecision study, the "ground truth" refers to the true concentration of ferritin in the control samples used. This would be established through robust analytical methods, often by the control manufacturer, and not by individual human experts in a consensus manner.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device study. The comparison is quantitative to an existing method or to established control values, not subject to human expert adjudication.

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 an automated immunoassay system for quantitative determination of ferritin, not an AI-assisted diagnostic tool that involves human interpretation of varied cases.

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

Yes, the studies reported (method comparison and imprecision) represent standalone performance of the IMMAGE® Immunochemistry System Ferritin Reagent. The system performs the quantitative determination of ferritin automatically without human interpretive input for each measurement. Human involvement is in operating the system, loading samples, and interpreting the final quantitative results output by the machine.

7. The Type of Ground Truth Used

• For the method comparison study: The ground truth was the quantitative results obtained from the predicate device, the Abbott IMx® Ferritin system. This is a form of "reference method" ground truth.
• For the imprecision study: The ground truth was the known or assigned concentration values of control materials at different ferritin levels.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. This is a traditional immunoassay system, not an AI-based device that undergoes a training phase with a specific dataset. The closest analogue would be the calibration process, which uses the IMMAGE® Immunochemistry System Ferritin Calibrator according to its instructions.

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

Not applicable, as there is no "training set" in the context of AI/machine learning for this device. For the calibrators, the "ground truth" (assigned values) would be established by the manufacturer through rigorous analytical methods, often traceable to an international reference standard (e.g., WHO Standard as mentioned for the IMMAGE System FER Calibrator).

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The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

Based on the provided text, the device is a medical calibrator, not an AI or imaging device, so many of the requested fields (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or not found in the document. The document focuses on regulatory approval based on substantial equivalence to a predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing key attributes.

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

• Sample Size for Test Set: Not applicable/Not provided. This is a calibrator, not a diagnostic device evaluated with patient samples. The "test" here is a comparison of product attributes against a predicate.
• Data Provenance: Not applicable/Not provided in the context of patient data. The comparison is based on the characteristics of the calibrator itself.

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

• Not applicable. Ground truth for patient data is not relevant for a calibrator. The "truth" in this context is the stated characteristics of the calibrator and its preparation against a WHO standard.

4. Adjudication method for the test set

• Not applicable. There is no subjective interpretation or adjudication process described as this is a product comparison, not a diagnostic performance study.

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 for a clinical chemistry system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a calibrator, not an algorithm.

7. The type of ground truth used

• For the calibrator values themselves: WHO standard (2nd IS for predicate, 3rd IS for modified device). This refers to the internationally recognized standard for ferritin. The base matrix is bovine albumin, and the ferritin is from human liver.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, there is no training set for this type of device.

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AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.

Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.

Fluorescent immunoassay reagents.

Here's the analysis of the provided information regarding the AuraFlex® Ferritin device:

Due to the nature of the device (immunoassay for Ferritin), many of the acceptance criteria points (like expert readers, adjudication, MRMC studies) are not applicable as this is not an image-based or human-interpretive diagnostic device. The study described focuses on the analytical performance of the assay.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample size: 94 human serum samples.
   • Data provenance: Not explicitly stated, but the samples were human serum. The document doesn't specify the country of origin or if it was retrospective or prospective.

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

   • Not applicable. This is an immunoassay, and "ground truth" for its analytical performance is typically established by comparison to a reference method or a predicate device, not by expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The "ground truth" was established via a comparative study with another Ferritin 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 an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

   • The study performed was a standalone analytical performance study of the AuraFlex® Ferritin assay. It compared the results of the new assay directly against an "Other Ferritin assay" without human-in-the-loop performance measurement.

6. The type of ground truth used:

   • The "ground truth" for demonstrating substantial equivalence was established by comparison to an "Other Ferritin assay," which implicitly served as the reference or predicate method. This is an analytical comparison rather than a clinical ground truth like pathology or outcome data.

7. The sample size for the training set:

   • Not applicable. This device is an immunoassay, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. The "training" here would be related to assay optimization and validation during development, not data-driven model training.

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

   • Not applicable (as per point 7).

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VITROS Ferritin Reagent Pack - For the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). Measurements of Ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemachromatosis (iron overload) and iron deficiency anemia.

VITROS Ferritin Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Ferritin in human serum and plasma (heparin)

VITROS Ferritin Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of Ferritin

Not Found

This document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (IVD), specifically for the Vitros™ Immunodiagnostic Products Ferritin Reagent Pack, Calibrators, and Controls. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter itself does not contain the acceptance criteria or a detailed study description proving the device meets those criteria. Such information would typically be found in the original 510(k) submission that the FDA reviewed. The letter only states that the FDA has reviewed the submission and found the device substantially equivalent for its stated indications for use.

Therefore,Based on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the specifics of the study. The document is an FDA clearance letter, not the submission itself where such details would be laid out.

To answer your request, I would need access to the actual 510(k) submission (K973331) for the Vitros™ Immunodiagnostic Products Ferritin Reagent Pack, Calibrators, and Controls. This submission would contain the performance data, acceptance criteria, study design, and details about the test and training sets.

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