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The DSL-10-8500 ACTIVE™ Free 3-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.

The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample.

The provided text describes a Substantial Equivalence study for the DSL ACTIVE™ Free β-hCG ELISA kit (DSL-10-8500) against a predicate device, the DSL-8300 Intact-hCG IRMA, for the quantitative determination of Free β-hCG in human serum as an aid in detecting pregnancy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy thresholds that the new device needed to meet. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (DSL-8300 Intact-hCG IRMA).

The reported performance that serves as the basis for substantial equivalence is primarily through a linear regression analysis and an assessment of physiological profiles in normal individuals.

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

• Test Set Sample Size: 98 pregnant patient samples
• Data Provenance: The document does not explicitly state the country of origin. It mentions "pregnant patient samples" and "serum samples from 20 normal males and 20 non-pregnant females." It is a retrospective evaluation as samples were "collected and assayed" to compare the two methods.

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

The document does not specify a number of experts or their qualifications for establishing ground truth. The "ground truth" for the comparison study appears to be the results obtained from the predicate device, the DSL-8300 Intact-hCG IRMA. For the normal male and non-pregnant female samples, the ground truth is based on the expected physiological range of Free β-hCG in those populations, which is established medical knowledge.

4. Adjudication Method for the Test Set

Not applicable. The study is a comparative method study, not one requiring expert adjudication of subjective findings from the device. The comparison is against the predicate device's quantitative output.

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 an in-vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic tool that involves human readers interpreting images or data.

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

Yes, the study describes the standalone performance of the DSL ACTIVE™ Free β-hCG ELISA kit in comparison to the predicate device. It is a fully automated/semi-automated assay designed to provide a quantitative result without direct human interpretation of complex patterns, but rather an operator running the test and recording the numerical output.

7. The Type of Ground Truth Used

• For the 98 pregnant patient samples, the ground truth was essentially the measurement provided by the predicate device (DSL-8300 Intact-hCG IRMA). The new device's results were compared against this established method.
• For the 20 normal males and 20 non-pregnant females, the ground truth was expected physiological levels for Free β-hCG, which are well-established in medical literature and served to demonstrate the device's ability to correctly identify low/undetectable levels in non-pregnant individuals.

8. The Sample Size for the Training Set

Not explicitly stated. The document describes a "verification" or "validation" study for substantial equivalence rather than explicitly detailing a separate "training set" for the assay's development. IVD assays like ELISA kits are typically developed and optimized using various samples during their R&D phase, but this document focuses on the final validation study.

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

Not explicitly stated. As above, this document focuses on the validation of the device. The development and optimization ("training") of such an assay would typically involve using samples with known concentrations of hCG (e.g., spiked samples, commutable clinical samples with reference method values) to calibrate and refine the assay's performance characteristics. This information is usually part of the internal development process and not always detailed in an FDA 510(k) summary focused on substantial equivalence.

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