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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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PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Roche Diagnostics Elecsys® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin, and NT-proBNP for monitoring accuracy and precision on Elecsys immunoassay analyzers.

The provided text is a 510(k) summary for a medical device called "Elecsys® PreciControl Cardiac," which is a quality control material. It describes the device, its intended use, and claims substantial equivalence to a previously marketed predicate device.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets such criteria. This type of information would typically include performance metrics, statistical analysis, and details about clinical or laboratory studies.

Therefore, I cannot provide the requested information from the given text. The text primarily focuses on regulatory submission details and a comparison to a predicate device, rather than detailed performance study results.

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Control for Elecsys® CK-MB and Troponin-T assays.

Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays.

This document is a 510(k) summary for a medical device called Elecsys® PreciControl Cardiac 1 and 2. It describes the device's characteristics and its comparison to a predicate device, Elecsys® CK-MB and Elecsys® Troponin-T CalSets.

The information provided does not include acceptance criteria for a performance study. It focuses on demonstrating substantial equivalence to a predicate device by comparing features such as matrix, analytes, standardization, storage conditions, application test system, reconstitution methods, manufacturer, and open vial stability. The document explicitly states that the intended use has changed to a quality control material rather than a diagnostic device, which implies that a clinical performance study demonstrating diagnostic accuracy against acceptance criteria, as typically understood for AI/ML devices, is not relevant here.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, sample sizes for test sets, ground truth establishment for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to the content of this 510(k) summary.

Here's an attempt to answer the quantifiable questions based only on the provided text, while acknowledging the limitations:

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

The document does not specify "acceptance criteria" in the context of a performance study proving the device meets those criteria. Instead, it compares features of the new device (Elecsys® PreciControl Cardiac) to a predicate device (Elecsys® CK-MB and Troponin-T CalSets) to demonstrate substantial equivalence, particularly for its new intended use as a quality control material.

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. This is a 510(k) summary for a control material, not a diagnostic device requiring a clinical test set to assess performance metrics like sensitivity or specificity. No specific "test set" in the context of clinical performance is mentioned.

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. Ground truth for a clinical test set is not relevant for this type of device and submission.

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

Not applicable. Adjudication methods are not relevant for this type of device and submission.

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 is not an AI/ML device, nor a diagnostic device that would involve human readers.

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

Not applicable. This is not an AI/ML device. The device itself is a control material for other assays.

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

Not applicable. The "truth" for this control material would be its manufactured concentration and stability characteristics, validated through chemical/analytical methods, not clinical ground truth. The document does not detail these validation methods for the control material itself, but rather focuses on comparing its characteristics to a predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and thus does not have a "training set."

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

Not applicable. This is not an AI/ML device.

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