(75 days)
The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine. The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.
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I am sorry but this document does not contain the requested information. The document is a 510(k) premarket notification letter from the FDA regarding several RIA test kits for catecholamines. While it mentions the device names, regulation numbers, and intended use, it does not provide details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the scientific study reports or summary of safety and effectiveness, which are not included here.
§ 862.1165 Catecholamines (total) test system.
(a)
Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.