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Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.

Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

The IBL Estradiol LIA is a luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol in saliva and serum.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as distinct pass/fail thresholds in the provided document. Instead, the document presents performance characteristics and comparisons to established methods. The "acceptance" is implied by the FDA's substantial equivalence determination. We can infer the functional performance criteria from the reported values and comparisons.

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

• Normal Ranges in Saliva:

  • Premenopausal Women: 28 women (month profiles, so multiple samples per woman), age 19-43.
  • Postmenopausal Women: 5 women, age 42-62.
  • Males: 40 males, age 20-63.
  • Data Provenance: Not explicitly stated, but likely prospective for the normal range establishment as saliva samples were collected daily "until first day of bleeding" or as single samples for postmenopausal women and males. No country of origin is specified, but the manufacturer is based in Germany, suggesting European or international data.

• Comparison of Serum and Saliva (to published/commercial RIA):

  • Saliva Comparison: 50 saliva samples.
  • Serum Comparison: 60 serum samples.
  • Data Provenance: Not explicitly stated, but likely retrospective or a combination of prospective/retrospective for convenience from adult healthy individuals. No country of origin is specified.

• Serum to Saliva Comparison (using IBL Estradiol LIA):

  • Paired Samples: Not explicitly stated, but derived from "saliva and serum pairs collected at the same time." The number of pairs is not provided.
  • Data Provenance: Not explicitly stated, but likely prospective for this specific comparison.

• Cross-Reactivity, Analytical Sensitivity, Functional Sensitivity, Precision, Linearity, Recovery:

  • The sample sizes for these analytical performance studies are embedded within the tables (e.g., n=10 for precision at each level). These are typically laboratory studies using spiked samples, controls, and calibration materials rather than patient samples for the direct "test set" definition often associated with diagnostic device clinical trials.
  • Data Provenance: Laboratory validation studies.

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

• Normal Ranges: The "ground truth" here is the observed ranges in the healthy populations studied. There is no mention of external experts establishing a ground truth for these ranges; they are empirical observations from the study participants themselves.
• Comparison Studies: The "ground truth" for the comparison studies are the results obtained from the "published procedure that used a modification in the handling of saliva for a typical RIA test" and a "commercially available RIA test kit." These are established reference methods. There is no mention of individual expert adjudicators for these data points.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. The comparisons are against established laboratory methods, not subjective diagnoses requiring adjudication by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic immunoassay, not an imaging or diagnostic device requiring interpretation by human readers. Therefore, an MRMC study and effects of AI assistance are not relevant to this submission.

6. Standalone Performance Study

Yes, the entire submission describes the standalone performance of the IBL Estradiol LIA. The comparisons to RIA methods ("Comparison of Serum and Saliva," "Serum to Saliva Comparison") are designed to demonstrate its performance relative to existing technologies, but the listed metrics (Normal Ranges, Cross-reactivity, Sensitivity, Precision, Linearity, Recovery) represent the intrinsic performance of the IBL Estradiol LIA device itself.

7. Type of Ground Truth Used

• Normal Ranges: Empirical observation from defined healthy populations.
• Comparison Studies: Results from established, commercially available, or published reference immunoassay methods (RIA).
• Analytical Performance (Cross-Reactivity, Sensitivity, Precision, Linearity, Recovery): These are based on established laboratory analytical methods using controlled samples, calibrators, and known concentrations (e.g., spiked samples).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. For an immunoassay, the equivalent would be the samples used to develop and optimize the assay's reagents, protocols, and calibration curves. This information is not provided in detail. The normal range studies and comparison studies would be considered part of the validation and testing, rather than a "training set" in the modern AI sense.

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

As there is no distinct "training set" discussed in the context of AI/ML, this question is not directly applicable. However, for the development of the immunoassay itself, the "ground truth" for calibrators and controls would be established through rigorous analytical chemistry techniques, often traceable to international standards, and verified by expert analytical chemists during the assay development phase. The document implicitly relies on standard immunoassay development and validation practices.

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