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Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overlose and in monitoring levels of digoxin to ensure proper therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

The Elecsys Digoxin assay employs a competitive test principle using a monoclonal antibody specifically directed against digoxin. Digoxin in the sample competes with the added digoxin derivative labeled with biotin for the binding sites on the ruthenylated antibody-complex. Results are determined via a calibration curve which is instrument- specifically generated by 2point calibration and a master curve provided via the reagent barcode. The reagent working solutions include: RackPack (kit placed on instrument) M: Streptavidin-coated microparticles, R1: Anti digoxin AbRu(bpy) 3+ and R2: Digoxin-derivativebiotin. PreciControl Cardiac II is a lyophilized control serum based on human serum in two concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys CK MB, CK MB STAT, Myoglobin, Myoglobin STAT, proBNP II, proBNP II STAT, and Digoxin immunoassays.

The provided document is a 510(k) summary for the Elecsys Digoxin Immunoassay and Elecsys PreciControl Cardiac II. It describes the device, its intended use, and various performance evaluations conducted.

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

1. Table of acceptance criteria and the reported device performance

The document lists performance characteristics in a comparative table (Table 1 and Table 2) between the "Predicate Device Elecsys Digoxin Immunoassay (K973112)" and the "Candidate Device Elecsys Digoxin Immunoassay." While specific acceptance criteria are not explicitly stated for each test, the reported performance data for the candidate device can be listed. The comparison to the predicate device implies that the candidate device's performance should be equivalent or better.

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The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria for the Digoxin Immunoassay.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the Digoxin Immunoassay: "for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information for clinical management of patients administered digoxin, aiding the physician in monitoring digoxin levels to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, or details of a specific study.
3. Details regarding number or qualifications of experts, or adjudication methods.
4. Information on MRMC comparative effectiveness studies.
5. Details on standalone algorithm performance.
6. The type of ground truth used.
7. Sample size for the training set or how ground truth for the training set was established.

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