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The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

The provided document is a 510(k) summary for the OSOM™ Classic hCG-Urine Test. It describes the product, its intended use, and its substantial equivalence to other devices. However, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample size for test sets, data provenance, number/qualifications of experts, or adjudication methods.
• Details regarding multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone algorithm performance tests.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets or how their ground truth was established.

This document is a regulatory submission summary, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report or performance validation.

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