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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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For the quantitative determination of Total Bilirubin in serum. For IN VITRO diagnostic use. Bilirubin is a bile pigment normally found in serum as a result of red cell destruction. It is a product of hemoglobin breakdown by the reticuloendothetial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted.

The elevation of total serum bilirubin may occur due to hemolytic processes, liver disease, or a disorder of the biliary tract.

Traditional methods of measuring bilirubin are based on the reaction of bilirubin with a diazo reagent to form the colored compound: azo-bilirubin. The diazo reaction can be accelerated by the addition of various chemicals. For example, Malloy-Evelyn (1) used ethanol, Jendrassik-Grof (2) used caffeine, and Walters-Gerarde (3) used DMSO. Modifications of these methods included the addition of surfactants as solubilizing agents (4). In this method, a 2,4-dichlorophenyl diazonium salt is used as the diazo reagent and the reaction is facilitated by the use of a surfactant.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Bilirubin-SL (TOTAL) Assay." This document is a regulatory communication and does not contain the specific information required to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory obligations, but it does not include performance study data.

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