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SASTM Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.

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The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The letter primarily:

• Acknowledges receipt and review of the 510(k) notification (K990684).
• Determines the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls and potential additional controls.
• Provides contact information for CLIA categorization, labeling, and other regulatory matters.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets, data provenance, or study design.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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