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The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.

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The provided document does not contain enough information to complete the requested table and answer the questions regarding acceptance criteria and study details.

This document is a 510(k) clearance letter from the FDA for a device called "Maxie hCG Urine." It confirms that the device has been found substantially equivalent to a legally marketed predicate device. While it states the "Indications For Use" and the "cut off concentration of 20 mIU/ml" for early detection of pregnancy, it does not include:

• Specific acceptance criteria: The document doesn't outline a table of performance metrics (e.g., sensitivity, specificity, accuracy) that the device needed to meet.
• Study details: There is no mention of the study conducted to demonstrate the device's performance, including:
  • Reported device performance values.
  • Sample size (test or training set).
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC or standalone study details.
  • Type of ground truth used.
  • Training set information.

To provide the requested information, a separate study report or detailed submission document to the FDA would be necessary.

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