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This document provides a summary of safety and effectiveness information for the Hitachi Clinical Analyzer S TEST Reagent Cartridges, intended for quantitative measurement of cholesterol and triglycerides
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How to fill out 510k summary - accessdata
How to fill out 510(k) SUMMARY
01
Identify the device you are submitting for 510(k) clearance.
02
Gather comparison information for a legally marketed predicate device.
03
Compile data demonstrating that your device is safe and effective.
04
Complete the 510(k) form, including the device description, intended use, and labeling.
05
Prepare a summary of the safety and effectiveness data.
06
Include any necessary performance testing or clinical data.
07
Ensure your submission complies with formatting and content requirements as per FDA guidance.
08
Submit the completed 510(k) Summary to the FDA.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices that are intended for human use in the U.S.
02
Companies looking to market a device that is similar to a legally marketed predicate device.
03
Entities that need to demonstrate that their device is substantially equivalent to an existing device.
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People Also Ask about
What is the rejection rate for 510k?
The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.
What is the 510k decision making process?
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 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 501k process?
The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.
How long does 501k approval take?
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.
How long does it take to get a 510 K approval?
It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.
What is the purpose of a 510 K to determine?
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.
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What is 510(k) SUMMARY?
A 510(k) SUMMARY is a document that medical device manufacturers submit to the FDA to demonstrate that their device is substantially equivalent to a legally marketed device, known as a predicate device.
Who is required to file 510(k) SUMMARY?
Medical device manufacturers who wish to market their devices in the United States and claim substantial equivalence to an existing device must file a 510(k) SUMMARY with the FDA.
How to fill out 510(k) SUMMARY?
To fill out a 510(k) SUMMARY, manufacturers must provide detailed information including a description of the device, its intended use, technology comparison to predicate devices, and other information related to safety and efficacy.
What is the purpose of 510(k) SUMMARY?
The purpose of the 510(k) SUMMARY is to allow the FDA to evaluate the safety and effectiveness of new medical devices and to ensure that they are as safe and effective as devices already on the market.
What information must be reported on 510(k) SUMMARY?
The information required on the 510(k) SUMMARY includes device identification, applicability of the regulation, statements on equivalence, descriptions of the device and materials, manufacturing processes, and performance testing results.
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