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The quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use.

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This is a 510(k) clearance letter for an in vitro diagnostic device (Bilirubin-SL (Total) Assay), which means the FDA has determined it is substantially equivalent to a predicate device. For such devices, detailed studies proving device performance against specific acceptance criteria, including sample sizes, expert qualifications, and ground truth methodologies, are typically found in the 510(k) submission itself, not directly in the clearance letter or the Indications for Use statement provided here.

The provided document does not contain the information requested in points 1-9 regarding the acceptance criteria and the study proving the device meets those criteria. Such details are usually part of the applicant's 510(k) submission, specifically within the performance data sections.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.

The document only provides:

• Trade/Device Name: Bilirubin-SL (Total) Assay
• Regulation Number: 21 CFR 862.1110
• Regulation Name: Bilirubin (total or direct) test system
• Regulatory Class: Class II
• Product Code: CIG
• Indications for Use: The quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use.

To obtain the detailed study information, one would need to access the full 510(k) submission (K023330) which is typically available through the FDA's public access policies, but not contained within this particular letter.

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