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The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconiugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.

The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assav. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estricl present in the sample.

This document describes the DSL 3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA Kit. It's a Radioimmunoassay (RIA) kit designed for the quantitative measurement of Unconjugated Estriol in human serum, intended as a diagnostic aid for fetoplacental distress. The submission claims substantial equivalence to the DPC FREE ESTRIOL RIA.

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1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state "acceptance criteria" but implies them through the equivalence study's design and results.

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

• Sample Size: 126 patient samples.
• Data Provenance: Not explicitly stated, but it's implied to be human serum samples collected for this comparison study. Whether this was retrospective or prospective is not specified. The country of origin is also not mentioned, but given the submitter's address in Texas, USA, it is likely from the USA.

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

• This information is not provided in the document. The study compares two RIA assays, and the "ground truth" for the comparison is essentially the measurement from the predicate device (DPC FREE ESTRIOL RIA) or the agreement between the two methods, rather than an expert clinical assessment.

4. Adjudication Method for the Test Set

• This information is not applicable or not provided. This study is a method comparison for an in-vitro diagnostic device, not a multi-reader imaging study requiring adjudication of expert interpretations. The comparison is based on quantitative analytical results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

• No, an MRMC comparative effectiveness study was not done. This document describes the validation of an in-vitro diagnostic (IVD) test kit, not an imaging device or a system requiring human interpretation as part of its primary function. Therefore, there's no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in essence, this is a standalone performance study in the context of an IVD. The DSL RIA kit operates as an automated (or semi-automated) laboratory test. Its performance is evaluated based on its analytical output (quantitative measurement of Unconjugated Estriol) compared to a predicate device, without direct human intervention in the "reading" or "interpretation" of the analytical signal in the same way an AI algorithm might augment a radiologist. The human element comes in performing the assay and interpreting the final quantitative result.

7. The Type of Ground Truth Used

• The "ground truth" for this study is the measurement obtained from the predicate device, the DPC FREE ESTRIOL RIA. The intent is to show that the new device's measurements are substantially equivalent and highly correlated with those of an already approved device. It's a comparative analytical ground truth, not pathology, expert consensus, or outcomes data in the traditional sense for diagnostic accuracy.

8. The Sample Size for the Training Set

• This information is not applicable or not provided. RIA kits are laboratory assays based on biochemical reactions and do not typically involve "training sets" in the machine learning sense. The assay's parameters are developed and optimized through laboratory research and development, but not "trained" on a dataset of samples.

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

• This information is not applicable as there is no "training set" for an RIA kit in the context of machine learning. The development process for an RIA involves optimizing reagents, incubation times, and other assay parameters to achieve desired performance characteristics.

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