Search Results

Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma.

Sandwich principle. Total duration of assay: 18 minutes (37 °C).
• 1st incubation (9 min.): 10µL of sample, a biotinylated monoclonal prolactin- specific antibody (75 µL), and a monoclonal prolactin-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (40 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+3)
•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 (0.4 second read frame).
•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 describes the Elecsys® Prolactin Assay, an immunoassay for the quantitative determination of human prolactin. The document is a 510(k) premarket notification summary, aiming to establish substantial equivalence to a predicate device, the Enzymun® Prolactin Assay.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet for approval. Instead, it presents various performance characteristics and compares them to the predicate device. The implied acceptance is that the new device's performance is comparable to or better than the predicate.

Given the comparative nature, I will present the performance metrics shown for the new device (Elecsys® Prolactin Assay) and the predicate device (Enzymun® Prolactin Assay) for comparison. The "acceptance criteria" here is implicitly that the Elecsys® Prolactin Assay performs acceptably in these categories, and its performance is at least equivalent to the predicate.

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

• Precision Test Set (N):

  • Elecsys® Prolactin Assay: 60 samples at each level (Low, Mid, High), totaling 180 measurements for precision.
  • Enzymun® Prolactin Assay (Predicate): 119 samples at Low and Mid levels, 120 at High level, totaling 358 measurements for precision.

• Method Comparison Test Set (N):

  • Elecsys® Prolactin Assay vs. Enzymun-Test® Prolactin: 99 samples (for both Least Squares and Passing/Bablok).

• Interfering Substances & Specificity: The sample sizes for these tests are not explicitly stated as 'N' values for each substance but rather as the tested levels at which no interference or cross-reactivity was observed. These are likely conducted using controlled spiked samples rather than a large clinical cohort.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these in-vitro diagnostic studies, they are typically prospective laboratory-based studies using controlled samples and clinical specimens.

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

This type of in-vitro diagnostic device (immunoassay) does not typically rely on human expert review (e.g., radiologists, pathologists) to establish "ground truth" in the same way an imaging AI device would.

• Ground Truth Determination: For assays like this, the "ground truth" for method comparison and performance evaluation is generally the results from a well-established, validated reference method (like the predicate device in this case, or a recognized gold standard). Precision, linearity, and interference are evaluated based on analytical measurements against known values (e.g., spiked samples, reference materials).
• Experts: While laboratory experts (e.g., clinical chemists, medical technologists) are involved in performing and validating such tests, they are not "establishing ground truth" through their interpretation in the context of this summary. Their role is to execute the assays and interpret the analytical data according to established protocols.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are common in scenarios where human interpretation (e.g., reading medical images) contributes to establishing a ground truth that might be subjective or require consensus. For an immunoassay, the results are quantitative measurements, and the "truth" is either the chemical standard or the result from a validated reference 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

Not applicable.

• This device is an automated in-vitro diagnostic assay. It does not involve "human readers" interpreting output in the same way an imaging AI would.
• There is no "AI assistance" component in the context of human interpretation for this device. The device provides a quantitative measurement.

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

Yes, the performance characteristics presented (precision, linearity, detection limit, method comparison, interference, specificity) are inherently standalone performance of the Elecsys® Prolactin Assay system (reagents plus instrument). It operates as an automated system producing quantitative results without human interpretive input for the measurement itself. Human-in-the-loop aspects would involve a clinician interpreting the result in the context of a patient's overall health, but not in the measurement process itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's evaluation primarily relies on:

• Analytical Standards/Reference Materials: For parameters like precision, linearity, and detection limit, the "ground truth" is based on the known concentrations of prolactin in control samples or reference materials.
• Reference Method (Predicate Device): For method comparison, the results from the predicate Enzymun-Test® Prolactin Assay serve as a reference ("ground truth") to demonstrate comparable performance.
• Spiked Samples: For interference and specificity studies, the "ground truth" involves known concentrations of interfering substances or related hormones added to samples, and results are checked against expected prolactin values.

8. The Sample Size for the Training Set

The document does not explicitly mention "training set" or "validation set" in the context of machine learning, because this is not an AI/ML device. The described assays are chemical/immunological systems.

However, if we interpret "training set" as the data used to initially develop, optimize reagents, and establish preliminary assay parameters, that information is not provided in this 510(k) summary. These summaries typically focus on the final validation studies.

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

Not applicable, as this is not an AI/ML device with a "training set" that requires ground truth establishment in the described manner. The "ground truth" for the development and optimization of such assays would involve rigorous analytical chemistry techniques, established reference methods, and internal validation steps guided by scientific principles and regulatory requirements for in-vitro diagnostics.

Ask a specific question about this device