(53 days)
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome. This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma.
I am sorry, but the provided text from the FDA 510(k) approval letter for the "Randox Ammonia" device does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.
The document is primarily focused on the FDA's determination of substantial equivalence to a predicate device, which allows the "Randox Ammonia" kit to be marketed. It states the indications for use and mentions the assay's mechanism but does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes for test or training sets, data provenance, or expert qualifications.
- Information on ground truth establishment, adjudication methods, or MRMC studies.
Therefore, I cannot extract the specific information you requested from this document.
§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.