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The DSL LH IRMA assay is intended for the quantitative determination of LH in human serum. The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction.

The DSL LH IRMA kit was developed for the quantitative measurement of LH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the test tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound LH is directly proportional to the concentration of the LH present in the sample.

Acceptance Criteria and Study Details for DSL 4600 LH IRMA Kit:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 41 patient samples.
• Data Provenance: Not explicitly stated, but based on the context of a medical device submission, it is assumed to be human serum samples. The samples were collected and assayed using both methods, implying a prospective collection or at least a concurrent analysis for this specific comparison. The country of origin is not specified.

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

• This information is not provided in the summary. The study design centers around a comparative performance against an existing device (DPC LH IRMA) rather than establishing a de novo ground truth with clinical expert consensus. The DPC LH IRMA itself serves as the reference standard.

4. Adjudication Method for the Test Set

• Not applicable. The study compares the new device (DSL LH IRMA) directly against a predicate device (DPC LH IRMA) by running the same samples on both assays. There is no mention of independent expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done based on the provided summary. This study focuses on the analytical performance of the device rather than human-in-the-loop diagnostic accuracy.

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

• Yes, this study represents a standalone performance evaluation of the DSL LH IRMA kit. The assay directly measures LH levels in serum samples, and its performance is assessed by comparing its quantitative results against a predicate device. There is no human interpretation component described in the evaluation itself, beyond the technicians performing the assays.

7. The Type of Ground Truth Used

• The "ground truth" for this study was the quantitative measurement of LH obtained from the DPC LH IRMA, which served as the predicate device. The study aimed to demonstrate that the new device produced results that strongly correlated with this established method.

8. The Sample Size for the Training Set

• This information is not provided. The DSL LH IRMA kit is an immunoradiometric assay, not a machine learning algorithm that typically requires a distinct training set. The development of such an assay involves extensive laboratory work, reagent optimization, and calibration, but not a "training set" in the sense of supervised learning.

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

• Not applicable, as there isn't a "training set" in the conventional machine learning sense for this type of assay. The development and calibration of the DSL LH IRMA would have involved established laboratory practices to ensure accurate and reproducible measurement of LH, likely using characterized standards and reference materials. The "ground truth" during development would be the known concentrations of LH in these standards.

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