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Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use.

HCG is a hormone produced and secreted by the placenta following implantation. Its early presence and rapid increase in maternal urine make it an excellent marker for use in the diagnosis of pregnancy.

Scripps Laboratories hCG One-Step uses monoclonal and polyclonal antibody technology to specifically detect hCG in urine.

The product is configured in a dipstick format. When the product is partially submerged in urine, the sample travels through the Test Strip. If hCG is present at levels of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater, a positive result, two distinct red bands will appear. If no hCG is present, a negative result, one red band, will appear.

Here's a breakdown of the acceptance criteria and study information for the Scripps Laboratories hCG One-Step device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of targets. Instead, it presents performance characteristics for the Scripps Laboratories hCG One-Step and compares them to legally marketed devices. The implied acceptance criteria are that the device's performance should be comparable or superior to these predicate devices.

Note on Timing: While the Scripps product takes 5 minutes, compared to 1 or 3 minutes for predicate devices, the other performance metrics (sensitivity, specificity, accuracy) are equal or better, suggesting this timing difference was not considered a significant hindrance to substantial equivalence.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 507 urine specimens.
• Data Provenance: The data was collected in a "multicenter field study." The document does not explicitly state the country of origin but implies a clinical laboratory or professional setting within the US, as it's for 510(k) approval by the FDA. The study was prospective in the sense that the Scripps device was being evaluated against a commercial benchmark using new specimens presented for testing.

3. Number of Experts and Qualifications for Ground Truth

• The document states that the ground truth for the test set was established by a "commercially available visual hCG test" (Quidel® Quick Vue® One-Step hCG Urine Test).
• The actual individuals performing the initial interpretations are described as "individuals with different educational backgrounds and training." There is no specific number of "experts" defined for establishing the ground truth beyond the performance of the predicate device.

4. Adjudication Method for the Test Set

The adjudication method was based on the results of a single, commercially available predicate device: the Quidel® Quick Vue® One-Step hCG Urine Test. There's no mention of multiple expert adjudicators or a specific voting/consensus method (e.g., 2+1, 3+1).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focuses on the standalone performance of the Scripps device compared to an existing device, not on the improvement of human readers with or without AI assistance. The device is a diagnostic test itself, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

Yes, a standalone performance study was done. The Scripps Laboratories hCG One-Step is a rapid, one-step immunoassay, meaning it produces a visual result directly. The performance data (sensitivity, specificity, accuracy) reflect the device's ability to correctly identify hCG levels independently. "Individuals with different educational backgrounds and training" performed the testing, suggesting human interpretation of the visual result, but the performance metrics are attributed to the device itself.

7. Type of Ground Truth Used

The ground truth used was established by a predicate commercial device's result. Specifically, the Quidel® Quick Vue® One-Step hCG Urine Test was considered the reference standard against which the Scripps Laboratories device was compared for "qualitatively positive or negative for hCG."

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of immunoassay usually undergoes extensive internal R&D and validation with various contrived and clinical samples to optimize its formulation and design. The data presented in this 510(k) summary represents a clinical validation (test set) of the final product.

9. How Ground Truth for the Training Set Was Established

As no dedicated "training set" is described, there's no information on how its ground truth would have been established. For the development of an immunoassay, the "ground truth" for internal optimization typically involves:

• Using samples spiked with known concentrations of hCG.
• Comparing results to highly accurate laboratory methods (e.g., quantitative immunoassay, mass spectrometry) or established reference standards.
• Testing with known positive and negative clinical samples confirmed by other means.

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