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Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.

The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the "Iron Standard" device:

Important Note: The provided document is a 510(k) summary for a calibrator device. Regulatory summaries for calibrators typically focus on demonstrating substantial equivalence to a predicate, not on clinical performance or diagnostic accuracy studies in the same way an AI-powered diagnostic device would. Therefore, many of the requested fields related to clinical studies, human readers, and ground truth in a diagnostic context will not be applicable or explicitly stated.

Acceptance Criteria and Reported Device Performance

The provided document, K052002, is a 510(k) summary for a calibrator. For calibrators, "acceptance criteria" and "device performance" are typically related to their ability to accurately calibrate an assay, their stability, and their comparability to other calibrators. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against predefined acceptance criteria for accuracy or clinical use.

No explicit quantitative acceptance criteria or detailed performance study results (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The "study" here is primarily a substantial equivalence comparison.

Table of Acceptance Criteria and Reported Device Performance

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, demonstrating substantial equivalence to a legally marketed predicate device. For a diagnostic calibrator, the primary "proof" is the demonstration that it performs its calibration function safely and effectively, and that it is substantially equivalent to existing calibrators on the market. Specific performance data related to its calibration efficacy (e.g., accuracy of calibrated assays) would typically be part of a larger assay's submission, not the calibrator's alone unless novel.

Additional Information Not Applicable or Directly Stated for This Device Type:

Most of the following items are highly relevant for diagnostic devices, especially those utilizing AI, and involve clinical effectiveness studies. As "Iron Standard" is a calibrator, these are generally not applicable and are not found in this 510(k) summary.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a calibrator, not a diagnostic device undergoing a clinical performance study with a test set of patient data.

2. 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. Ground truth for a calibrator relates to its chemical properties and stability, not the interpretation of patient samples by experts.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a calibrator, not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, "ground truth" would relate to the gravimetric preparation and analytical confirmation of the concentration of Ferrous Ammonium Sulfate Hexahydrate, and its stability characteristics. This is a chemical/analytical ground truth, not a clinical one. The document mentions "gravimetrically prepared aqueous solution," which indicates a highly controlled laboratory method for establishing the "truth" of its concentration.

7. The sample size for the training set: Not applicable. This is a calibrator; it does not involve machine learning or training sets in the computational sense.

8. How the ground truth for the training set was established: Not applicable.

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An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease. For the quantitative determination of iron in serum and heparinized plasma. For IN VITRO diagnostic use.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "Iron-PC-SL Assay." This document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

The information requested in your prompt, such as specific acceptance criteria and the details of a study proving the device meets those criteria, including sample sizes, ground truth establishment, MRMC studies, or standalone performance, is not present in this type of regulatory correspondence.

This document confirms the device's classification and its ability to be marketed, but it does not contain the technical study details you are asking for. A typical 510(k) submission would include such studies, but the letter itself is just the FDA's response.

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The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.

The provided text describes a 510(k) submission for an in vitro diagnostic assay called "Iron." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to establish new acceptance criteria or conduct a multi-reader multi-case (MRMC) study. The information provided is characteristic of a clinical chemistry assay, which focuses on analytical performance rather than diagnostic accuracy involving human readers.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format. Instead, it presents performance characteristics and asserts substantial equivalence to a predicate device. The primary performance metrics are correlation with the predicate, precision, linearity, and limit of quantitation.

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

The document mentions "comparative performance studies" and "precision studies" but does not specify the sample size for these studies.

The data provenance is not explicitly stated regarding country of origin. The studies appear to be retrospective as they are comparing the new assay to an existing, established predicate device.

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

This information is not applicable and therefore not provided in the document. For a clinical chemistry assay like this, "ground truth" is typically established by the reference method (the predicate device) or by established analytical standards, not by human expert consensus or interpretation of test results.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology for image-based diagnostics) to resolve discrepancies among multiple expert readers. This is not relevant for a quantitative chemical assay.

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 focuses on the impact of a device on human reader performance, typically for diagnostic imaging or similar interpretation tasks. The Iron assay is an in vitro diagnostic for quantitative determination, not an interpretive tool for human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

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

Yes, in essence, the entire performance evaluation of the Iron assay is a standalone performance assessment. Clinical chemistry assays are designed to operate independently and provide a quantitative result. The performance characteristics (correlation, precision, linearity, sensitivity) described are the standalone performance of the assay itself, without human interpretation as part of the primary output.

7. The Type of Ground Truth Used:

For the comparative performance studies, the ground truth was the results obtained from the Boehringer Mannheim® Iron assay on the Hitachi® 717 Analyzer (K854298), which served as the reference or predicate method. For precision, linearity, and sensitivity, the ground truth would be based on known concentrations in control materials or spiked samples.

8. The Sample Size for the Training Set:

This information is not provided and is generally not applicable in the context of this device. Clinical chemistry assays like the Iron assay are typically developed and validated using well-established chemical principles and analytical methodologies. While there's an optimization process during development that might involve testing numerous samples, the concept of a "training set" in the machine learning sense (where an algorithm learns from labeled data) is not relevant to this type of device.

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

As noted above, the concept of a "training set" with established ground truth, as understood in machine learning/AI, is not applicable to this clinical chemistry assay. The performance is assessed against established analytical methods and standards.

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The Iron assay is used for the quantitation of iron in human serum on the ALCYON 300/300i Analyzer. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.

Here's an analysis of the provided text regarding the Abbott Laboratories Iron assay:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria: The document doesn't explicitly state numerical acceptance criteria for each metric. Instead, it uses phrases like "acceptable correlation" and "These data demonstrate that the performance of the Iron assay is substantially equivalent." This implies that the reported performance values were deemed sufficient to demonstrate substantial equivalence to the predicate device (Raichem Serum Iron assay). For a quantitative test like this, acceptance limits would typically be based on established clinical chemistry guidelines and comparison to the predicate's known performance for method correlation, precision, and linearity.

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

• Sample Size for Test Set: The document explicitly states "Comparative performance studies were conducted using the ALCYON™ Analyzer." However, it does not specify the sample size used for these comparative studies (e.g., how many patient samples were tested).
• Data Provenance: The document does not provide information regarding the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the studies were conducted using the ALCYON™ Analyzer.

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

This information is not applicable to this type of device. The Abbott Iron assay is a clinical chemistry assay for quantitative determination of iron in human serum. Its "ground truth" is established by comparing its performance against a legally marketed predicate device (Raichem Serum Iron assay) using patient samples, not by expert interpretation of images or other subjective data. No human experts are used to establish a "ground truth" for the measured iron levels in this context.

4. Adjudication Method for the Test Set

This information is not applicable to this device. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective assessments, such as radiology interpretations or clinical diagnoses. For a quantitative chemical assay, the comparison is directly between the numerical results of the new device and the predicate device.

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

A MRMC comparative effectiveness study was not performed or reported. This type of study typically involves multiple human readers interpreting cases with and without AI assistance to measure the impact of AI on reader performance. The Abbott Iron assay is an automated in vitro diagnostic test, not an AI-assisted diagnostic tool requiring human interpretation comparison.

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

Yes, a standalone performance study was done. The entire performance characterization (method correlation, precision, linearity, sensitivity) described in the document is a standalone performance assessment of the Abbott Iron assay running on the ALCYON™ Analyzer. There is no human-in-the-loop component for the measurement or result generation itself; the device processes samples and provides quantitative results. The comparison is between the new device's results and those of a predicate device.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the results obtained from the legally marketed predicate device, the Raichem® Serum Iron assay on the Roche® Cobas Mira® Plus Automated Chemistry System. The study establishes substantial equivalence by demonstrating that the new device's measurements align well with the predicate device's measurements.

8. Sample Size for the Training Set

The document does not provide any information about a training set. This is consistent with a traditional chemical assay development and validation process, which typically does not involve machine learning models that require a distinct training set in the way AI/ML algorithms do. The development likely involved calibration and optimization steps, but these are distinct from "training a model" in the AI sense.

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

As no training set is mentioned or applicable in the context of this traditional clinical chemistry assay, the method for establishing its ground truth is not applicable.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device