(104 days)
The Marukin Diagnostic's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.
Assay Kit for Urinary Total Bile Acid Sulfate
The provided document is a 510(k) clearance letter from the FDA for an "Assay kit for Urinary Total Bile Acid Sulfate." This type of document does not typically contain the detailed study information, acceptance criteria, or performance data that you are requesting.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not provide the specifics of the performance studies that led to this determination. Such details would typically be found in the manufacturer's 510(k) submission summary or in peer-reviewed publications.
Therefore, I cannot extract the requested information from the provided text. The document only states the intended use of the device: "The Marukin Diagnostic's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults."
§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
(a)
Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.