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This document provides a summary of safety and effectiveness information for the Piccolo C-Reactive Protein Test System submitted to the FDA as part of the 510(k) premarket notification process.

How to fill out piccolo c-reactive protein test

How to fill out Piccolo C-Reactive Protein Test System 510(k) Premarket Notification

1. Obtain the Piccolo C-Reactive Protein Test System and familiarize yourself with the device and instructions.
2. Gather all necessary documentation including device descriptions, indications for use, and performance data.
3. Prepare a summary of safety and effectiveness data comparing the Piccolo system to predicate devices.
4. Fill out the FDA Form 3514, providing details about the manufacturer and the device.
5. Compile information on the device's design, materials, and chemical composition.
6. Include any labeling and instructional materials intended for users of the device.
7. Submit the 510(k) application electronically through the FDA's eSubmitter system or via mail, as required.
8. Pay the applicable user fee for the 510(k) submission.
9. Maintain communication with the FDA during the review process to address any questions or concerns they may have.

Who needs Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

1. Healthcare providers who want to perform C-reactive protein testing in their laboratories.
2. Clinics and hospitals needing to monitor inflammation levels in patients.
3. Laboratory personnel involved in clinical diagnostics.
4. Regulatory professionals and quality assurance teams working with diagnostic test systems.

People Also Ask about

What is pre-market notification?

Premarket notification is the process through which these new devices claim substantial equivalency to a preexisting device and are automatically classified into the same class as that predicate device.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Information from the Design Controls process is crucial. The FDA usually takes 30-90 days to process 510(k) submissions—however, the entire premarket notification process can take much longer. If accepted, the submission is listed in the database. Generally, Class II medical devices require a 510k submission.

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is a 510 K premarket notification?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is 510k premarket notification?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

For pdfFiller’s FAQs

What is Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

The Piccolo C-Reactive Protein Test System 510(k) Premarket Notification is a regulatory submission to the U.S. Food and Drug Administration (FDA) that allows the manufacturer to market the Piccolo device for measuring C-reactive protein levels in patients, thus demonstrating the device's safety and effectiveness.

Who is required to file Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

Manufacturers or entities that intend to market the Piccolo C-Reactive Protein Test System in the United States are required to submit the 510(k) Premarket Notification to the FDA to ensure compliance with medical device regulations.

How to fill out Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

To fill out the Piccolo C-Reactive Protein Test System 510(k) Premarket Notification, manufacturers must compile specific information including device description, indications for use, technological characteristics, performance data, labeling information, and any preclinical or clinical study results to demonstrate safety and effectiveness.

What is the purpose of Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

The purpose of the Piccolo C-Reactive Protein Test System 510(k) Premarket Notification is to provide the FDA with the necessary information to assess the device's safety and effectiveness, ensuring that it meets the regulatory requirements before being marketed in the U.S.

What information must be reported on Piccolo C-Reactive Protein Test System 510(k) Premarket Notification?

The information that must be reported includes the device name and classification, intended use, manufacturing details, descriptions of the device's components and principles of operation, test methodologies, labeling, performance testing results, and comparisons to similar legally marketed devices.