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This document is a 510(k) summary for the 3M Integrated Cycler, which is a real-time Polymerase Chain Reaction thermocycler intended for in vitro diagnostic use in laboratories.

How to fill out 3m integrated cycler 510k

How to fill out 3M Integrated Cycler 510(k) Summary

1. Gather all necessary information regarding the 3M Integrated Cycler.
2. Prepare the device description, including its intended use and operational principles.
3. Compile a list of technological characteristics and compare them with the predicate device.
4. Complete the non-clinical testing information, including performance testing, safety data, and biocompatibility.
5. Include any clinical testing data, if applicable, to support the device's safety and efficacy.
6. Fill out the summary of the regulatory history of the device, including previous submissions and outcomes.
7. Ensure that all sections meet the FDA's formatting and content requirements.
8. Review the summary for completeness and accuracy before submission.

Who needs 3M Integrated Cycler 510(k) Summary?

1. Regulatory affairs professionals working on device submissions.
2. Manufacturers of the 3M Integrated Cycler.
3. Healthcare providers interested in using the device.
4. Investors or stakeholders needing to understand the device's regulatory status.

People Also Ask about

What is the 510k FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is the FDA 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the 510k clearance process?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

What is the difference between 510k and FDA approval?

De Novo submissions establish a new classification for devices without predicates and offer a streamlined pathway for low—to moderate-risk devices. 510(k) submissions rely on the substantial equivalence to a predicate device and are the most common route for device approval.

What is the 5 10k approval process?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What is the 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

How long does it take to get a 510 K approval?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

For pdfFiller’s FAQs

What is 3M Integrated Cycler 510(k) Summary?

The 3M Integrated Cycler 510(k) Summary is a document submitted to the FDA that outlines the details and performance characteristics of the 3M Integrated Cycler, a medical device used for molecular diagnostics.

Who is required to file 3M Integrated Cycler 510(k) Summary?

Manufacturers and developers of the 3M Integrated Cycler are required to file the 510(k) Summary to demonstrate that the device is safe and effective for its intended use.

How to fill out 3M Integrated Cycler 510(k) Summary?

To fill out the 3M Integrated Cycler 510(k) Summary, manufacturers must provide details about the device, its intended use, comparison to predicate devices, performance data, and labeling information, following the FDA guidelines.

What is the purpose of 3M Integrated Cycler 510(k) Summary?

The purpose of the 3M Integrated Cycler 510(k) Summary is to gain FDA clearance, ensuring that the device meets regulatory standards for safety and effectiveness before it can be marketed.

What information must be reported on 3M Integrated Cycler 510(k) Summary?

The 3M Integrated Cycler 510(k) Summary must report device identification, indications for use, technological characteristics, performance data, and a comparison with predicate devices, including any differences and their significance.