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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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For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.

Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

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The provided text is a summary of a premarket notification for the RDI Ferritin Kit, which is an in vitro diagnostic device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Name: RDI Ferritin Kit
• Regulation Information: 21 CFR § 866.5340, Regulation Name: Ferritin Immunological Test System, Regulatory Class: II, Product Code: DBF
• FDA Determination: Substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
• Indications for Use: Quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, useful in assessing iron stores and evaluating iron deficiency anemia and hemochromatosis.

Therefore, I cannot provide the requested information as it is not present in the given text.

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The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.

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I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves whether the Direct TIBC Calibrator Set meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance study details, acceptance criteria, or performance data.

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For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.

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This FDA 510(k) clearance letter and associated documents for the "RDI Extended Range hs CRP Kit" primarily focus on the regulatory approval process and device's "intended use." It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the detailed study information generally required to describe acceptance criteria and how a device meets them in the context of AI/ML or complex diagnostic performance.

The document specifically describes a C-reactive protein immunological test system, which is a laboratory assay. The information requested in your prompt (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone performance) is typically relevant for AI/ML-based diagnostic devices, image analysis software, or devices that rely on complex algorithms and human interpretation. This document deals with a quantitative chemical assay.

Therefore, many of the requested fields cannot be directly answered from the provided text because they are not applicable to the type of device described or the information is simply not present in a 510(k) clearance letter.

However, I can extract what is available and clarify what is missing or not applicable:

Device Name: RDI Extended Range hs CRP Kit (C-reactive protein)
Regulation Number: 21 CFR 866.5270
Regulation Name: C-reactive protein immunological test system
Regulatory Class: Class II
Product Code: DCK

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative "acceptance criteria" (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed "reported device performance" in a table as would be expected for a study demonstrating analytical or clinical performance of a diagnostic test.

For a C-reactive protein kit, acceptance criteria would typically involve analytical performance characteristics like:

• Accuracy: Agreement with a reference method.
• Precision (Repeatability/Reproducibility): How consistent the results are.
• Linearity/Measuring Range: The range over which the test provides accurate results.
• Limit of Detection (LoD): The lowest concentration that can be reliably detected.
• Limit of Quantitation (LoQ): The lowest concentration at which analyte can be accurately quantified.
• Interferences: Effects of various substances on the test.

The 510(k) clearance indicates that the device has been found "substantially equivalent" to a legally marketed predicate device. This implies that the device's performance (analytical and, if applicable, clinical) has been demonstrated to be comparable to that predicate. However, the specific data demonstrating this is not provided in this regulatory letter.

Study Details (Based on available information and general understanding of 510(k)s for this type of device)

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

   • Acceptance Criteria: Not explicitly stated in the provided documents. Would typically reflect analytical performance goals (e.g., % bias vs. predicate, %CV for precision, linearity range).
   • Reported Device Performance: Not explicitly stated in the provided documents. Would typically include data on accuracy, precision, linearity, LoD, LoQ, and interference.

   Example (Hypothetical, as not provided in text):

   Performance Metric	Acceptance Criteria (e.g., vs. Predicate)	Reported Device Performance
   Accuracy (Bias)	≤ 10% bias for concentrations X-Y	X% bias
   Precision (CV)	≤ 10% CV at low/medium/high conc	Y% CV
   Linearity Range	0.2 - 200 mg/L	0.2 - 200 mg/L
   Limit of Detection (LoD)	≤ 0.2 mg/L	0.15 mg/L

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

   • Sample Size: Not specified in the provided documents. Clinical laboratory device validation studies typically use a range of patient samples (e.g., 50-100+ samples spanning the measuring range and including various clinical conditions).
   • Data Provenance: Not specified. For 510(k)s, studies are typically conducted by the manufacturer, often internally or at external research sites, and would be prospective in nature for validation.

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

   • Not applicable / Not specified. For a C-reactive protein immunoassay, the "ground truth" is typically established by comparative analysis against a well-characterized reference method or a legally marketed predicate device, rather than expert interpretation.

4. Adjudication method for the test set:

   • Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are relevant for subjective interpretations (e.g., imaging reads). For a quantitative assay, results are numerical. Data might be statistically analyzed against a comparison method.

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

   • No. This is not applicable to a quantitative C-reactive protein assay kit. MRMC studies are used for devices that involve human interpretation, often in conjunction with AI.

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

   • Yes, implicitly. A C-reactive protein kit, as described, is a standalone diagnostic test (an in vitro diagnostic device or IVD). Its performance is evaluated on its own analytical capabilities to measure CRP in a sample. It doesn't typically involve an "algorithm only" in the sense of AI/ML, but rather a biochemical reaction and detection system.

7. The type of ground truth used:

   • Comparative method / Predicate device results. For this type of IVD, the "ground truth" would be established by comparing the device's results to a recognized reference method (e.g., gravimetric method if available, or another FDA-cleared predicate CRP assay known for its accuracy).

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. Development of the assay components and optimization of the reagents would involve extensive internal testing and formulation work, but not a "training set" of data for an algorithm.

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

   • Not applicable. See point 8.

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For in vitro diagnostic use only.

The RDI Extended Range CRP Calibrator Set is intended for medical purposes for use with the RDI Extended Range hsCRP Kit, to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

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This looks like a 510(k) clearance letter for a medical device called "RDI Extended Range CRP Calibrator Set."

Based on the provided text, the document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.

Here's why and what information is available:

• Device Type: This device is a "Calibrator" (specifically, an "Extended Range CRP Calibrator Set"). Calibrators are used to establish reference points for assays (like a C-reactive protein assay). They are not typically "devices" in the sense of AI algorithms that perform an analysis or make a diagnosis.
• Regulatory Pathway: This is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device. This pathway often focuses on demonstrating that the new device is as safe and effective as an existing one, rather than novel performance studies with acceptance criteria as you've described for AI.
• Content of the Document: The letter is an official notification of clearance from the FDA. It confirms that the device can be marketed. It discusses general controls, regulations, and labeling, but it does not present a detailed study report or performance data.

Therefore, I cannot fill out the requested table or answer most of your questions as the information is not present in the provided text.

Here is what can be extracted to answer some parts, and explanations for why other parts cannot be answered:

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

• Cannot be provided. This document does not contain acceptance criteria or performance data for the calibrator in the way you've outlined. The FDA's substantial equivalence determination implies that the device performs comparably to a predicate, but the specific performance metrics and acceptance thresholds are not detailed here.

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

• Cannot be provided. No study data (test set size, provenance) is included in this regulatory clearance letter.

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)

• Cannot be provided. This is not relevant for a calibrator's regulatory clearance and no such information is in the document. Ground truth for a calibrator would typically relate to its manufactured concentration values and traceability to international standards, not expert interpretation.

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

• Cannot be provided. Not applicable or available 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

• Cannot be provided. This relates to AI/software performance with human readers, which is not what this device is.

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

• Cannot be provided. This device is a calibrator, not an algorithm.

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

• For a calibrator, the "ground truth" is its manufactured, certified value. The document mentions: "The accuracy of the CRP measurement is insured by using calibrators that are traceable to the international reference preparation (CRM470)." This indicates that the ground truth for the calibrator's values comes from its traceability to an internationally recognized standard.

8. The sample size for the training set

• Cannot be provided. Not applicable for this type of device and no such information is in the document.

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

• Cannot be provided. Not applicable for this type of device and no such information is in the document.

In summary, the provided text is an FDA 510(k) clearance letter for a calibrator, which is a different type of medical device than an AI-driven diagnostic tool. Therefore, most of the questions, which are tailored to AI/software performance studies, cannot be answered from this document.

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The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

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This looks like a 510(k) summary for a medical device called "RDI hs CRP (C-reactive protein) Calibrator Set". The document provided is the FDA's clearance letter and the "Indications For Use" statement.

Unfortunately, this document does not contain the information requested regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study proving the device meets acceptance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria in the way a clinical trial or performance verification study would.

Therefore, I cannot populate the requested tables and information based solely on the provided text. To answer your questions, I would need a different type of document, such as a detailed performance study report or the technical documentation submitted with the 510(k) application.

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For in vitro diagnostic use only. The RDI hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.

Not Found

This letter from the FDA is a clearance letter for a medical device called the "RDI hs CRP Kit (C-reactive protein)". It states the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the 510(k) submission document itself, which is not provided here.

Therefore, I cannot fulfill your request for the table and study details based on the provided text. The document only confirms the FDA's decision to clear the device for marketing.

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For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.

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The provided document describes a 510(k) submission for the Magnetic TIBC Kit, focusing on its substantial equivalence to a predicate device, the J & S Microcolumn and Iron Saturating reagent kit for TIBC. The evaluation is a correlation study between the two methods rather than a study on a new AI/ML device. Therefore, many of the typical acceptance criteria and study design elements requested, such as human-in-the-loop performance, ground truth establishment for AI, and various expert-related details, are not applicable in this context.

Here's the information that can be extracted or inferred from the provided text:

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

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

• Sample Size: 103 samples
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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 study is a correlation study between two assay methods and does not involve human expert interpretation for establishing a "ground truth" in the context of an AI/ML device. The "ground truth" for the test set is effectively the results obtained from the predicate device (J & S microcolumn method).

4. Adjudication method for the test set

This information is not applicable as the study design is a direct comparison of analytical measurements from two different laboratory methods, not a study involving human interpretation that would require 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

This information is not applicable as the device is an in-vitro diagnostic kit, not an AI-powered diagnostic system that assists human readers.

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

This information is not applicable as the device is not an algorithm but an in-vitro diagnostic kit. Its performance is evaluated as a standalone analytical method in comparison to another analytical method.

7. The type of ground truth used

The "ground truth" for the purpose of demonstrating substantial equivalence in this context is the results obtained from the predicate device (J & S microcolumn method). The study aimed to show that the new Magnetic TIBC Kit yielded results that were highly correlated with an established, legally marketed method.

8. The sample size for the training set

This information is not applicable. The study described is a direct comparison of analytical methods, not an AI/ML model that requires a distinct training set. The 103 samples were used for the correlation study itself.

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

This information is not applicable for the reasons stated in point 8.

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