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The ACON Quik-Check II Home Pregnancy Test Device is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is intended for non-professional, over-the-counter use.

The ACON Quik-Check II Home Pregnancy Test Device is intended for non-professional, over-the counter use for the qualitative identification the elevated level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

The test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a Strepavidin-Biotin ligand-binding system to qualitatively detect elevated levels of hCC in urine sample. The assay is conducted by using a dropper to transfer three drops of urine from a urine sample that has been collected in a cup, or clean, dry container and observing for the formation of colored lines. The specimen migrates via capillary action along the components of the test device to react with the colored conjugate. During migration, hCG molecules in the positive urine sample react with the hCG-specific antibodies, which were conjugated with colored particles, and form a colored line on the "Test Region" of the membrane. A colored line forms in the test (T) region indicates a positive result; while absence of this colored line indicates a negative result. To serve as a procedural control, a colored line at the control (C) region will always appear, indicating adequate sample volume and proper wicking, regardless of the presence of hCG. Absence of this control line in the C region indicates that the test result is "invalid".

The ACON Quik-Check II Home Pregnancy Test Device qualitatively detects hCG in urine with a designated cutoff hCG concentration of 25 mIU/ml. This test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300 mIU/ml), hFSH (1.000 mIU/ml), and hTSH (1,000 uIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.

The provided text describes the ACON Quik-Check II Home Pregnancy Test Device, its intended use, and the studies conducted to establish its substantial equivalence. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Consumer field study: 113 female participants
  • Retrospective focus group study on reproducibility and precision: 35 female participants
• Data Provenance: The studies were described as "Clinical studies" and a "consumer field study" and "retrospective focus group study." There's no explicit mention of the country of origin of the data, but the context of the 510(k) submission to the FDA suggests the studies were likely conducted in the US or in a manner compliant with US regulations for medical device submissions. The "retrospective" nature of the focus group study is explicitly mentioned.

3. Number of Experts and their Qualifications for Ground Truth

• Not Applicable. For a home pregnancy test device, the "ground truth" for the clinical study was established by comparing the results of the new device to a predicate device (another hCG test). The document does not describe the use of human experts to establish ground truth for individual cases in the test set.

4. Adjudication Method

• Not Applicable. As the ground truth was established by comparison to a predicate device, an adjudication method involving experts making decisions on cases is not described.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted as this is a standalone diagnostic device for consumer use, not an AI-assisted diagnostic tool for human readers.

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

• Yes, the performance evaluated is the standalone performance of the device. The ACON Quik-Check II Home Pregnancy Test Device itself is the "algorithm" in this context, and its ability to detect hCG and provide accurate results is what was tested, without human intervention in result interpretation beyond following instructions. The "consumer field study" and "retrospective focus group study" assessed how well consumers could use and interpret the device's standalone results.

7. Type of Ground Truth Used

• The ground truth was established by comparison to a predicate device, specifically the ACON QUIK-CHECK Home Pregnancy Test Device (K012215). This means the performance of the new device was measured against the established performance of an already-marketed and accepted pregnancy test.

8. Sample Size for the Training Set

• Not Applicable. This device is a rapid diagnostic test, not an AI/machine learning model that requires a training set in the conventional sense. The "development" of the device involves biochemical and engineering principles, not statistical learning from a data set.

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

• Not Applicable. As there is no "training set" in the context of an AI/machine learning model, this question is not relevant. The device's design and operating parameters are based on scientific principles of antibody-antigen reactions and established hCG detection methods.

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