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Immunoassay for the in vitro quantitative determination of c1-fetoprotein in human serum and in the management of patients with non-seminomatous germ cell tumors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e immunoassay analyzers.

Immunoassay for the in vitro quantitative determination of αι-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys AFP utilizes a sandwich test principle and has a total test duration of 18 minutes.

• 1st incubation: 10 uL of sample, a biotinylated monoclonal AFP specific antibody, and . a monoclonal AFP specific antibody labeled with a ruthenium complex® react to form a sandwich complex.
• 2nd incubation: After 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/ProCell M. 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 barcode or e barcode.
• a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )

The reagent rackpack (M, R1, R2) is labeled as AFP:

• M: Streptavidin-coated microparticles (transparent cap), 1 bottle. 12 mL: Streptavidin-. coated microparticles 0.72 mg/mL; preservative.
• R1: Anti-AFP-Ab~biotin (gray cap), 1 bottle, 17 mL: Biotinylated monoclonal anti-. AFP antibodies (mouse) 4.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative.
• R2: Anti-AFP-Ab~Ru(bpy) (black cap), 1 bottle, 17 mL: Monoclonal anti-AFP . antibodies (mouse) labeled with ruthenium complex 12.0 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative.

The provided text describes a 510(k) premarket notification for the Elecsys AFP immunoassay. While it details numerous non-clinical tests conducted to prove the device's performance, it does not describe a study involving a "human-in-the-loop" or "algorithm-only" performance study in the context of an AI/ML device. The device described is an "immunological test system" and its performance is evaluated based on quantitative analytical metrics rather than the type of diagnostic performance (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices interpreting medical images or complex data for diagnostic purposes.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC studies, effect size of human reader improvement with AI) are not applicable or cannot be extracted from the provided text for this specific device.

However, I can extract information related to the acceptance criteria and performance of the described immunoassay device based on the non-clinical tests performed.

Here's a breakdown of the available information based on your request, focusing on what can be extracted and noting what cannot (due to the nature of the device and the provided document):

Device: Elecsys AFP Immunoassay (K220176)

Purpose of the study (as described in the document): To demonstrate substantial equivalence of the updated Elecsys AFP assay to a predicate device (K981282) by improving biotin tolerance and reducing streptavidin interference. The studies are non-clinical evaluations of the analytical performance of the immunoassay.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All predefined acceptance criteria was met" for the various tests. While the specific numerical acceptance criteria (e.g., acceptable range for precision, linearity, interference limits) are not fully detailed, the reported performance is often given or implied by the "met" statement and the claimed range/limits.

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

• Precision (Repeatability, Intermediate Precision): Not explicitly stated, but CLSI EP05-A3 typically involves multiple runs over several days with specific sample replicates.
• Lot-to-lot Reproducibility: Used "three reagent lots."
• Limit of Blank/Detection/Quantitation: Not explicitly stated, but CLSI EP17-A2 involves specific sample types and replicates.
• Linearity: Evaluated on "one cobas e 601 analyzer" using samples spanning the linearity range, but the number of distinct samples or replicates is not specified beyond "0.58 IU/mL - 1129 IU/mL".
• High-Dose Hook Effect: Assessed on "one cobas e 601 analyzer" in "two-fold determination" for "both samples."
• Interference (Endogenous): "Seven endogenous substances were evaluated."
• Interference (Exogenous): "17 commonly used and ten specially used pharmaceutical compounds" were evaluated.
• Method Comparison: "A total of 181 serum sample concentrations were between 1.58 and 966 IU/mL."
• Anticoagulant Effect: "native, single-donor samples drawn into serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma primary tubes." (Number of samples or donors not specified).
• Data Provenance: The document does not specify the country of origin for the samples/data or if they were retrospective or prospective. Given the nature of analytical validation studies for IVD devices, they are typically prospective studies performed in a controlled laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is an immunoassay, not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" for these analytical studies is derived from established laboratory methods, reference materials, and defined analytical ranges.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication process as typically seen in AI/ML diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not an AI/ML device; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or was not performed.

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

• Not Applicable (in the context of AI/ML). The device itself is an automated immunoassay. Its performance is inherently "standalone" in that it produces a quantitative result without human "interpretation" of a complex output, but this is a very different concept than an AI algorithm's standalone diagnostic performance. The document describes the analytical performance of the automated assay system.

7. The Type of Ground Truth Used:

• The "ground truth" for these types of analytical studies is based on:
  • Reference Methods/Materials: For linearity, analytical range, LoB/LoD/LoQ determinations, often using diluted/spiked samples with known concentrations.
  • Comparative Analysis: The "method comparison" compares the new assay's results against the existing (predicate) assay.
  • Defined Limits/Spiked Samples: For interference studies, known amounts of interferents are added to samples.
  • Established CLSI Guidelines: The studies explicitly state adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP05-A3, EP17-A2, EP06-A) for methodology, which dictate how "truth" is assessed for analytical performance.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's performance is based on its chemical and technological design, and its validation involves analytical testing rather than machine learning on a dataset.

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

• Not Applicable. As above, no "training set" in the AI/ML context.

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