(63 days)
The Marukin Shoyu Co., Ltd'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 Kits for Urinary Total Bile Acid Sulfate
The provided document is a 510(k) clearance letter from the FDA for "Assay Kits for Urinary Total Bile Acid Sulfate". This type of document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert qualifications, or details about AI/ML models.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". This means the device was cleared based on its substantial equivalence to a legally marketed predicate device, not on a new clinical trial demonstrating meeting specific performance criteria in the way a novel AI/ML device would.
Therefore, I cannot provide the requested information from this document.
§ 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.