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The Good Morning Test kit is a qualitative chromatographic immunoassay, which determines whether a woman is pregnant or not by identifying the presence of hCG in urine.

The Good Morning Test kit is a qualitative chromatographic immunoassay

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Standard Diagnostics, Inc. Good Morning Test" for Human Chorionic Gonadotropin (HCG). This document does not contain the detailed study information required to answer the questions about acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's clearance is based on substantial equivalence to an existing device, not necessarily on a new full clinical trial detailed within this document.

Therefore, I cannot provide the requested information from the given text. A 510(k) submission summary or the full submission itself would be needed to extract this level of detail about the device's performance study.

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