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510(k) Data Aggregation
(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."
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(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.
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