Get the free 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA - accessdata fda

This document provides a summary of the 510(k) premarket notification for the Quest Diagnostics Urine Cocaine Metabolite EIA, detailing its intended use, substantial equivalence to existing devices,

How to fill out 510k summary----quest diagnostics urine

How to fill out 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA

1. Gather all necessary documentation related to the Quest Diagnostics Urine Cocaine Metabolite EIA.
2. Identify the intended use of the device and the specific population that will be tested.
3. Describe the device, including its design, components, and method of operation.
4. Provide information on the performance characteristics of the device, including sensitivity, specificity, and accuracy data.
5. Summarize the results of any clinical studies performed.
6. Include a comparison of the device to predicate devices already cleared by the FDA.
7. Fill out the relevant sections of the 510(k) submission template provided by the FDA.
8. Ensure that all data is accurate and up to date before submission.
9. Submit the 510(k) Summary electronically through the FDA's submission system.
10. Monitor any feedback from the FDA and be prepared to provide additional information if requested.

Who needs 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

1. Manufacturers of the Quest Diagnostics Urine Cocaine Metabolite EIA.
2. Regulatory affairs professionals involved in medical device submissions.
3. Stakeholders ensuring compliance with FDA regulations for drug testing devices.
4. Laboratories conducting testing for cocaine metabolites who need cleared devices.
5. Researchers and developers looking to enter the market with similar devices.

People Also Ask about

What is the limit of detection for drug tests?

Screening immunoassay panel (qualitative) Drug ClassCutoff Concentration of Representative Drug AMPHETAMINES 500 ng/mL d-methamphetamine BARBITURATES 200 ng/mL secobarbital BENZODIAZEPINES 200 ng/mL lormetazepam CANNABINOIDS 50 ng/mL 11-nor-Δ9-THC-COOH8 more rows • Mar 14, 2023

What is the cut off for Quest Diagnostics test?

Employers can test for a wide range of drugs: Drug classScreen cutoffConfirmation cutoff 15 ng/mL 6 ng/mL Marijuana (THC) 3 ng/mL 1.5 ng/mL Methamphetamines 120 ng/mL 120 ng/mL Opiates Codeine, morphine, hydrocodone, hydromorphone, 6-AM 30 ng/mL 30 ng/mL*4 more rows

How long can Quest detect ?

After your last use, can remain detectable in your system for weeks. It will remain detectable to tests in your blood and salvia for up to 2 days (48 hours), for up to 4 days (96 hours), and hair follicles for up to 90 days.

What are the cut-off levels for a dot drug test?

What are the DOT Drug Test Cut-off Levels for 2025? Initial Test AnalyteInitial Test Cut-OffConfirmatory Test Cut-Off Marijuana (THCA) 50 ng/mL 15 ng/mL (Benzoylecgonine 150 ng/mL 100 ng/mL Codeine/morphine 2000 ng/mL 2000 ng/mL Hydrocodone/hydromorphone 300 ng/mL 100 ng/mL5 more rows • Mar 19, 2025

What is a normal level in ?

The following are considered to be normal results for this test: Negative screening test (immunoassay) for metabolite, benzoylecgonine:<300 ng/mL [3] Negative confirmatory test (GC-MS) for metabolite, benzoylecgonine: <150 ng/mL [3]

What can make you test positive for metabolite?

Each drug or substance has a specific level of metabolites at which a test would read positive. In the case of , 150 nanograms per milliliter of benzoylecgonine would result in a positive test.

For pdfFiller’s FAQs

What is 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

The 510(k) Summary for Quest Diagnostics Urine Cocaine Metabolite EIA is a premarket submission made to the FDA to demonstrate that the device is safe and effective for its intended use, which involves testing urine samples for cocaine metabolites.

Who is required to file 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

Manufacturers and importers of the Quest Diagnostics Urine Cocaine Metabolite EIA test are required to file a 510(k) Summary if they intend to market the device in the United States.

How to fill out 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

To fill out a 510(k) Summary for the Quest Diagnostics Urine Cocaine Metabolite EIA, manufacturers must provide information about the device's intended use, description, and comparison to a legally marketed device, as well as data supporting its safety and effectiveness.

What is the purpose of 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

The purpose of the 510(k) Summary is to provide the FDA with relevant information on the medical device to determine whether it is substantially equivalent to a pre-existing device in terms of safety and effectiveness.

What information must be reported on 510(k) Summary----.Quest Diagnostics Urine Cocaine Metabolite EIA?

The information that must be reported includes the device name, manufacturer details, intended use, technological characteristics, performance data, labeling, and any other relevant assessments related to safety and effectiveness.