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This test detects hCG in urine or serum. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine and serum of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories and physician's office laboratories (POL's) as an IVD test for the qualitative measurement of hCG in urine or serum.

The QuickCard hCG Combo Test, like many commercially available preqnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.

The QuickCard hCG Combo Test, an immunoassay for detecting Human Chorionic Gonadotropin (hCG) in urine or serum, was evaluated through a clinical sample correlation study and a blind labeled spiked hCG study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "clinical specimens" and "a blind labeled spiked hCG study."
• Data Provenance: Not explicitly stated. Given the manufacturer is Phamatech in San Diego, California, USA, and the FDA submission, it is likely that the studies were conducted in the USA. The studies involved both "clinical sample correlation" (suggesting prospective or retrospective clinical samples) and "blind labeled spiked hCG study" (suggesting controlled, laboratory-generated samples).

3. Number of Experts and Qualifications

Not applicable. The ground truth method described does not involve expert readers.

4. Adjudication Method

Not applicable. The ground truth method described does not involve expert adjudication.

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

No. The provided document evaluates the device's performance against predicate devices, not against human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes. The study focused on the performance of the QuickCard hCG Combo Test itself, comparing its results directly with predicate devices and spiked samples. This is a standalone performance evaluation of the device.

7. Type of Ground Truth Used

The ground truth was established by comparing the device's results to:

• Results from commercially available predicate devices: QuickVue, Phamatech QuickCard hCG Pregnancy Test (9008), and Abbott Test Pack Plus. These predicate devices are established methods for hCG detection, and their results served as a comparative ground truth.
• Known concentrations in "blind labeled spiked hCG study": This implies that hCG was added to samples at known concentrations, providing a controlled ground truth for accuracy.

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay, not an AI/ML model, so there is no "training set" in the context of machine learning. The studies described are for validation of the chemical assay.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an immunoassay.

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