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The ACON Quik-Check II Home Pregnancy Test Strip 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 test utilizes a combination of mouse monoclonal and goat polyclonal antibody in conjunction with a proprietary strepavidin-biotin ligand-binding system to qualitatively detect elevated levels of hCG in urine sample. The assay is conducted by dipping the test strip into the 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 strip 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". Therefore, two colored line show up on the test strip indicating a positive result; one line shows up near the wicking end indicating a negative and one line shows up away from the wicking end indicating an invalid result. The ACON Quik-Check II Home Pregnancy Test Strip 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 IU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine showed no cross-reactivity.

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Acceptance Criteria and Device Performance

Study Proving Device Meets Acceptance Criteria:

The provided text describes two primary clinical studies and additional laboratory studies to demonstrate the device's performance and substantial equivalence.

1. Clinical Studies:

   • Description: Two studies were conducted comparing the ACON Quik-Check II Home Pregnancy Test Strip to the predicate device, ACON Home Pregnancy Test (K993483).
     • One was a consumer field study.
     • The other was a retrospective focus group study on reproducibility and precision.
   • Sample Size:
     • Consumer field study: 113 female participants.
     • Retrospective focus group study: 35 female participants.
   • Data Provenance: Not explicitly stated, but the "consumer field study" and "retrospective focus group study" suggest the data likely originated from prospective collection for the consumer field study and retrospective analysis of collected data for the focus group study. The country of origin is not mentioned.
   • Number and Qualifications of Experts for Ground Truth: Not applicable or not specified for these particular studies, as the comparison was made against a predicate device (ACON Home Pregnancy Test - K993483), not against an independent expert assessment of pregnancy status.
   • Adjudication Method: Not specified.
   • MRMC Comparative Effectiveness Study: No, this type of study was not conducted or reported. The studies focused on comparing the new device against a predicate device's performance.
   • Standalone Performance: Yes, the device's performance (qualitative detection of hCG at 25 mIU/mL, standardization, cross-reactivity) was evaluated independently in laboratory studies. The "consumer field study" and "retrospective focus group study" also assess the device's standalone performance in real-world or simulated user environments, comparing its results to a predicate device.
   • Type of Ground Truth: The ground truth for these clinical studies was essentially the result obtained from the legally marketed predicate device (ACON Home Pregnancy Test - K993483), which is itself a pregnancy test.
   • Sample Size for Training Set: Not applicable. These were performance evaluation studies, not algorithm training.
   • How Ground Truth for Training Set was Established: Not applicable.

2. Additional Laboratory Studies:

   • Description: These studies investigated specificity, interference substances, urinary pH, urinary specific gravity, and the hook effect.
   • Sample Size: Not specified.
   • Data Provenance: Not specified, but generally laboratory studies are controlled experimental settings.
   • Number and Qualifications of Experts for Ground Truth: Not applicable, as these were analytical performance studies using known concentrations of substances or controlled conditions.
   • Adjudication Method: Not applicable.
   • MRMC Comparative Effectiveness Study: No.
   • Standalone Performance: Yes, these were standalone analytical performance tests to establish the device's robustness and accuracy under various conditions.
   • Type of Ground Truth: These studies used known concentrations of hCG, hLH, hFSH, hTSH and controlled conditions for pH, specific gravity, and the presence of interfering substances. This represents a type of controlled experimental ground truth.
   • Sample Size for Training Set: Not applicable.
   • How Ground Truth for Training Set was Established: Not applicable.

In summary, the device's acceptance was primarily based on demonstrating a high correlation (over 99%) with a legally marketed predicate device in user studies, along with robust analytical performance shown in laboratory studies.

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