Get the free 510(k) Summary for Mission U500 Urine Analyzer - accessdata fda
Show details
This document summarizes safety and effectiveness information for the Mission U500 Urine Analyzer, filed with the FDA under the 510(k) premarket notification process.
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign 510k summary for mission
Edit your 510k summary for mission form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your 510k summary for mission form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing 510k summary for mission online
Here are the steps you need to follow to get started with our professional PDF editor:
1
Sign into your account. It's time to start your free trial.
2
Prepare a file. Use the Add New button. Then upload your file to the system from your device, importing it from internal mail, the cloud, or by adding its URL.
3
Edit 510k summary for mission. Rearrange and rotate pages, insert new and alter existing texts, add new objects, and take advantage of other helpful tools. Click Done to apply changes and return to your Dashboard. Go to the Documents tab to access merging, splitting, locking, or unlocking functions.
4
Save your file. Select it from your records list. Then, click the right toolbar and select one of the various exporting options: save in numerous formats, download as PDF, email, or cloud.
With pdfFiller, dealing with documents is always straightforward. Try it right now!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out 510k summary for mission
How to fill out 510(k) Summary for Mission U500 Urine Analyzer
01
Prepare basic information: Include the name, address, and contact details of the device manufacturer.
02
Describe the device: Explain what the Mission U500 Urine Analyzer is and its intended use.
03
List indications for use: Detail the medical conditions or situations where the analyzer is applicable.
04
State the technological characteristics: Compare the U500 with predicate devices, highlighting similarities and differences.
05
Summarize performance testing: Include results from any clinical or non-clinical tests demonstrating the device's safety and effectiveness.
06
Provide labeling information: Attach proposed labels, instructions for use, and promotional materials.
07
Include risk analysis: Discuss potential risks associated with the device and how they are mitigated.
Who needs 510(k) Summary for Mission U500 Urine Analyzer?
01
Manufacturers of urine analyzers looking to market their products in the United States.
02
Regulatory consultants assisting companies with submissions to the FDA.
03
Health care providers interested in purchasing or using the device.
04
Importers and distributors who require FDA clearance for the product.
Fill
form
: Try Risk Free
People Also Ask about
How does a analyzer work?
As the passes through the flow cell, is illuminated by a special light source, and the images are recorded by a digital camera placed into the eyepiece of the microscope and transmitted to the computer. The software classifies these images and displays them on the screen for the operator.
How accurate is a analysis?
Among patients with specific symptoms of UTI, sensitivity of urinalysis for culture was 92% and specificity was 48%. Among those with nonspecific symptoms, sensitivity was 57% and specificity was 58%.
How does a analyser work?
A sample is collected in a sterile container. A reagent strip is dipped into the sample. The strip is placed inside the analyzer for scanning. The machine uses reflectance photometry to detect chemical changes on the strip.
What are the 10 parameters of Mission urinalysis reagent strips?
Comprehensive Testing: This 10-in-1 test strip accurately measures 10 key parameters including protein, glucose, ketones, bilirubin, urobilinogen, blood, pH, specific gravity, nitrite and leukocytes.
What is summary analysis of ?
Overview. A urinalysis is a test of your . It's used to detect and manage a wide range of disorders, such as urinary tract infections, kidney disease and diabetes. A urinalysis involves checking the appearance, concentration and content of .
What is the mission Analyser?
The Mission® U120 Analyzer is a great tool to use with the Mission Urinalysis Reagent Strips. This analyzer has the capability of running up to 120 tests per hour and saving and recalling 2000 results automatically.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is 510(k) Summary for Mission U500 Urine Analyzer?
The 510(k) Summary for the Mission U500 Urine Analyzer is a document submitted to the FDA demonstrating that this device is safe and effective for its intended use and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary for Mission U500 Urine Analyzer?
Manufacturers or importers of the Mission U500 Urine Analyzer who wish to market the device in the U.S. are required to file the 510(k) Summary.
How to fill out 510(k) Summary for Mission U500 Urine Analyzer?
To fill out the 510(k) Summary, manufacturers must complete a premarket notification submission form that includes device details, intended use, comparison to predicate devices, and supporting data.
What is the purpose of 510(k) Summary for Mission U500 Urine Analyzer?
The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the Mission U500 Urine Analyzer is safe and effective for its intended use.
What information must be reported on 510(k) Summary for Mission U500 Urine Analyzer?
The 510(k) Summary must report device name, intended use, description of the device, identification of predicate devices, performance data, labeling, and any potential risks associated with the device.
Fill out your 510k summary for mission online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
510k Summary For Mission is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
