Get the free 510(k) Summary for Diazyme hsCRP Assay Kit - accessdata fda

This document provides a summary of safety and effectiveness information for the Diazyme hsCRP assay kit, calibrator set, and control set, submitted to the FDA for regulatory approval.

How to fill out 510k summary for diazyme

How to fill out 510(k) Summary for Diazyme hsCRP Assay Kit

1. Identify the device and its intended use clearly.
2. Gather all relevant data regarding the Diazyme hsCRP Assay Kit, including testing results and performance characteristics.
3. Include a description of the assay principle and technology used in the kit.
4. Compile comparison data to a legally marketed predicate device, highlighting similarities and differences.
5. Provide labeling information including instructions for use, indications, and warnings.
6. Prepare risk analysis and quality control information.
7. Format the summary according to FDA guidelines with appropriate headings and sections.
8. Review the summary for clarity and completeness before submission.

Who needs 510(k) Summary for Diazyme hsCRP Assay Kit?

1. Manufacturers or importers of the Diazyme hsCRP Assay Kit.
2. Regulatory affairs professionals working on medical device compliance.
3. Healthcare providers or laboratories intending to use the assay for clinical testing.
4. Investors or business partners interested in the regulatory status of the assay.

People Also Ask about

What infections cause high HS CRP?

High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable

What does it mean when your hsCRP is high?

A CRP test result of more than 50 mg/dL is generally considered severe elevation. Results over 50 mg/L are associated with acute bacterial infections about 90% of the time.

What is Hscrp test in English?

A simple blood test can check your C-reactive protein level. A high-sensitivity C-reactive protein test, also called hs-CRP test, is more sensitive than a standard C-reactive protein test. That means the high-sensitivity test can find smaller increases in C-reactive protein than a standard test can.

For pdfFiller’s FAQs

What is 510(k) Summary for Diazyme hsCRP Assay Kit?

The 510(k) Summary for the Diazyme hsCRP Assay Kit is a document submitted to the FDA that provides information to demonstrate that the device is substantially equivalent to a legally marketed device. It includes details about the product, its intended use, and performance data.

Who is required to file 510(k) Summary for Diazyme hsCRP Assay Kit?

The manufacturer or the entity responsible for the Diazyme hsCRP Assay Kit is required to file the 510(k) Summary to the FDA before marketing the product.

How to fill out 510(k) Summary for Diazyme hsCRP Assay Kit?

To fill out the 510(k) Summary, the manufacturer must provide information including the device name, product code, intended use, device descriptions, comparison to predicate devices, and performance testing data.

What is the purpose of 510(k) Summary for Diazyme hsCRP Assay Kit?

The purpose of the 510(k) Summary is to demonstrate that the Diazyme hsCRP Assay Kit is safe and effective for its intended use and is substantially equivalent to an existing legal device.

What information must be reported on 510(k) Summary for Diazyme hsCRP Assay Kit?

The information that must be reported includes the device description, intended use, technological characteristics, comparisons to predicate devices, summary of performance testing, and labeling information.