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The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.

The DSL ACTIVE™ Renin Coated Tube IRMA kit was evaluated for its substantial equivalence to the Nichols Diagnostics ACTIVE Renin IRMA. The study involved comparing the results from both assays on patient samples to establish this equivalence.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly defines substantial equivalence based on a high correlation and a linear relationship between the new device and the predicate device's measurements. Specific thresholds for the slope, intercept, or correlation coefficient for "acceptance" are not explicitly stated as numerical criteria, but the reported values were deemed sufficient for substantial equivalence by the FDA.

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

• Sample Size: 53 patient samples
• Data Provenance: The document states "patient samples were collected." No specific country of origin is mentioned, but the submitting company is based in Webster, Texas, USA. The data is retrospective in the sense that samples were collected and then assayed simultaneously by both methods, rather than being collected solely for future study. The samples were chosen based on expected Renin levels (low, intermediate, and high) to ensure a representative range.

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

There were no independent experts used to establish a new ground truth. Instead, the Nichols Diagnostics ACTIVE Renin IRMA served as the reference method, or "ground truth," for comparison. The performance of this predicate device itself would have been established through prior studies.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used for the test set. The comparison was direct between the new device and the predicate device.

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

No MRMC comparative effectiveness study was conducted, as this device is an in vitro diagnostic (IVD) kit for quantitative measurement and does not involve human reader interpretation in the same way imaging devices might. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This study is a standalone performance evaluation of the device (the kit itself), comparing its results directly to a predicate device. There is no "human-in-the-loop" aspect to the device's function or the comparative study described.

7. Type of Ground Truth Used

The "ground truth" for the test set was the results obtained from the Nichols Diagnostics ACTIVE Renin IRMA, which served as the predicate device and the reference standard for comparison. This is a form of comparative ground truth against an established and legally marketed device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. The 53 patient samples were used for the comparative clinical study to demonstrate substantial equivalence, which is typically a validation or test set in the context of device approval. If a training phase was involved in the development of the DSL ACTIVE™ Renin Coated Tube IRMA kit, that information is not provided in this summary.

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

Since a dedicated training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. For IVDs like this, the "training" (development and optimization) often involves internal testing against characterized samples or reference materials, which would have their values established through validated reference methods or inter-laboratory comparisons, but these details are not part of this 510(k) summary.

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