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This document summarizes the safety and effectiveness of the Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) device, intended for rapid measurement of parathyroid hormone levels during
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How to fill out nichols advantage quick-intraoperative bio-intact
How to fill out Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary
01
Begin by gathering all necessary information regarding the Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) device.
02
Review the 510(k) submission guidelines provided by the FDA.
03
Fill out the applicant's information section, including name, address, and contact details.
04
Provide a detailed description of the device, including its intended use and how it works.
05
Include the predicate device information, citing its 510(k) number and justification of substantial equivalence.
06
Outline the device's performance features, including any clinical data or testing results that support safety and efficacy.
07
Address any potential risks associated with the device and how they are mitigated.
08
Complete the summary statement, which should summarize all critical aspects of the device and submission.
09
Review and ensure that all sections are filled out accurately and completely.
10
Submit the completed 510(k) summary to the FDA for review.
Who needs Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
01
Surgeons and medical professionals performing intraoperative monitoring of PTH levels.
02
Hospitals and surgical centers that require real-time PTH testing during procedures.
03
Patients undergoing parathyroid surgery or other procedures that involve PTH management.
04
Regulatory professionals and quality assurance teams involved in device compliance and safety.
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What is PTH intact intraoperative?
Intraoperative assessment of PTH. The intact PTH is a polypeptide produced by parathyroid and composed of 84 amino acids. Only parathyroids produce PTH; its half-life is of about 5 min in plasma.
What is a PTH intact parathyroid hormone test?
The PTH test measures the level of parathyroid hormone in the blood. PTH stands for parathyroid hormone. It is a protein hormone released by the parathyroid gland. A laboratory test can be done to measure the amount of PTH in your blood.
Why would a doctor order a PTH test?
The parathyroid gland secretes 1-84 and 7-84 parathyroid hormone (PTH) fragments, and its regulation is dependent on stimulation of the extracellular calcium-sensing receptor. While the intact PTH system detects both PTH fragments, the whole PTH system detects the 1-84PTH but not the 7-84PTH.
What is intraoperative parathyroid hormone monitoring?
Intraoperative parathyroid hormone (PTH) monitoring leverages the short half-life of the PTH hormone (three to five minutes) to provide the necessary assurance that a focused parathyroidectomy has been adequately performed (ie, all hypersecreting glands have been removed) before concluding the surgery [5-8].
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What is Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
The Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary is a document submitted to the FDA that outlines the safety and effectiveness of the Nichols Advantage assay for measuring bio-intact parathyroid hormone (PTH) in real-time during surgical procedures.
Who is required to file Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
The manufacturer of the Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) assay or any entity that seeks to market the device must file the 510(k) Summary.
How to fill out Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
To fill out the 510(k) Summary, the manufacturer must provide detailed information including device description, intended use, technological characteristics, performance testing, labeling, and comparison to predicates.
What is the purpose of Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
The purpose of the 510(k) Summary is to demonstrate that the Nichols Advantage assay is safe and effective for its intended use, and to obtain FDA clearance for marketing the device.
What information must be reported on Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84) 510(k) Summary?
Information that must be reported includes device identification, indications for use, device classification, summary of technological characteristics, performance data, and any potential risks associated with the device.
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