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The Elecsys Ferritin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys® Ferritin CalCheck 5 is a liquid product consisting of ferritin from human liver in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's an analysis of the provided text regarding the Elecsys Ferritin CalCheck 5, focusing on acceptance criteria and supporting studies:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria and proving the device meets them with a standalone study. The primary intent is to show that the new device (Elecsys Ferritin CalCheck 5) is as safe and effective as the previously cleared device (Elecsys Ferritin CalCheck).

Therefore, some of the requested information, such as detailed acceptance criteria for specific performance metrics (e.g., accuracy, precision), sample sizes for test sets, expert qualifications for ground truth, MRMC studies, or training set details, are not explicitly stated or are not applicable in the context of this 510(k) submission style.

However, I can extract the information that is present and explain why other details are missing based on the document's content.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a quality control material and not a new diagnostic assay, the "acceptance criteria" are implied by the comparison to the predicate device, particularly regarding its intended use, composition, and general performance (value assignment and stability). Specific quantitative acceptance criteria for performance are not explicitly listed in the submission document as they would be for a diagnostic test.

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

• Sample Size: Not explicitly stated. The document mentions the Elecsys Ferritin CalCheck 5 "was evaluated for value assignment and stability," but does not provide details on the number of samples, replicates, or lots tested.
• Data Provenance: Not specified. Standard practice for a control material would typically involve laboratory testing. The country of origin of the data is not mentioned, nor is whether the data was retrospective or prospective.

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

• Not Applicable. For a quality control material, "ground truth" often refers to the assigned concentration of the analyte (ferritin) within the control. This is typically established through a value assignment process using calibrated reference methods and internal standards, not by human expert consensus or a "test set" in the diagnostic study sense.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, there's no "test set" in the diagnostic study sense requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is relevant for imaging or interpretative diagnostic devices where human readers evaluate cases. This document describes a quality control material for an immunoassay, so an MRMC study is not relevant or applicable.

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

• Yes, effectively. The performance evaluation of a quality control material is inherently "standalone" in the sense that the material's characteristics (value assignment, stability) are assayed independently. There is no "human-in-the-loop" component in the direct performance assessment of the control material itself; it's an analytical performance evaluation.

7. The Type of Ground Truth Used

• Assigned Value/Reference Method. For quality control materials, the "ground truth" is typically the assigned value of the analyte (ferritin in this case) within the control material, established through a rigorous value assignment process using reference methods and calibrated instruments. The document only states the material "was evaluated for value assignment," implying this process was performed.

8. The Sample Size for the Training Set

• Not Applicable. This is a quality control material, not a machine learning algorithm. Therefore, there is no "training set."

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

• Not Applicable. See point 8.

Summary of Study Demonstrating Substantial Equivalence:

The study demonstrating that the Elecsys Ferritin CalCheck 5 meets "acceptance criteria" (defined by substantial equivalence to the predicate) is an internal performance evaluation focusing on value assignment and stability.

• The device was compared to the predicate device, Elecsys Ferritin CalCheck (K981281).
• The primary method of demonstrating equivalence was through a comparison of characteristics (analyte, format, handling, matrix, intended use, levels, stability) and a general statement that its performance (value assignment and stability) was "substantially equivalent."
• The document implies that laboratory studies were conducted to confirm the value assignment and stability of the new CalCheck 5, and the results of these studies were favorably compared to the expected performance of the predicate device, despite some minor differences (e.g., number of levels, opened stability duration, expanded analyzer use).

In essence, the "study" is a collection of internal analytical verification and validation activities designed to demonstrate that the new control performs comparably to the legally marketed predicate device, thereby supporting the claim of substantial equivalence. Specific quantitative data from these studies are not disclosed in this summary document.

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Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes. • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The provided text is a 510(k) summary for the Elecsys® Ferritin device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or a more comprehensive regulatory submission.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, data provenance, expert details, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• Details on how ground truth was established for training and test sets.

The document is purely a summary for regulatory clearance, stating the device's function and its substantial equivalence to a previously approved device (Enzymun-Test® Ferritin), without going into the specifics of performance studies required to demonstrate that equivalence against pre-defined criteria.

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