Drugs of Abuse Tests - FDA

Introduction

FDA regulates a type of IVD referred to as drugs of abuse tests that are sold to consumers or healthcare professionals in the United States FDA reviews many of these tests before they are sold for use. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that they produce accurate results. The FDA also reviews the test instructions and package inserts to help ensure that the end users can understand how to perform the tests easily and successfully.

If you are looking for more details, kindly visit Accu-Tell.

FDA does not review drugs of abuse tests intended for employment and insurance testing provided they include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)

The information on this webpage may be helpful to anyone who performs drugs of abuse testing, including consumers, employers, or trained medical professionals. In addition, the manufacturers of these tests may also be interested in the types of data typically submitted for FDA review.

Resources

FDA maintains a website called Device Advice that provides information on many aspects of tests that are regulated by FDA, including drugs of abuse tests. Within this website you may want to refer to the section entitled Overview of IVD Regulation.

For information specific to drugs of abuse, please refer to the following:

• Drugs of Abuse Home Use Tests
• Drugs of Abuse (Collection Kit)

In addition, you can find Decision Summaries for all drugs of abuse tests that FDA cleared for marketing. To find a Decision Summary, follow the steps below:

• navigate to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
• Search by 510(k) number, manufacturer’s name (Applicant Name), or name of the test (Device Name), or perform a very general search of many different drug test devices by selecting “Toxicology” in the drop-down menu under the section called “Panel.”
• Select particular tests in the “Device” column, and then “Decision Summary” 

Some drugs of abuse tests may be sold under different brand names although the test itself is identical. If you want to search by a brand name, navigate to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm, type the brand name into the “Test System / Manufacturer” field and select “Search.” This will produce a list of all of the tests with that name that have been cleared by FDA for marketing. 

FDA also maintains a database of tests that have been cleared for over-the-Counter (OTC) use. If you want to find a specific over-the-counter test, navigate to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm and enter any combination of the test (brand) name, the manufacturer name, or the document number (FDA clearance number) and select “Search.” This will display a list of all cleared OTC tests for the fields you entered. You may then select a specific test name. You can also search for all of the OTC tests for a particular drug by selecting it from the “Test Type” drop-down list.

Examples of Decision Summaries for Previously Cleared Drugs of Abuse Tests

Tests designed to be used with urine samples

OTC (home use)

• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf
• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf

Doctor’s office or Drug Treatment Center 

• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf

Lab-based

• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf
• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf
• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf

Tests designed to be used with oral fluid (saliva) samples

Lab-based

• http://www.accessdata.fda.gov/cdrh_docs/reviews/K.pdf

Workplace

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm?db=pmn&id=K

Tests designed to be used with hair samples

OTC

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm?db=pmn&id=K

Product Codes for Drugs of Abuse Tests

The FDA categorizes all regulated drug tests with a unique 3 letter product code. The following table lists commonly used product codes for drugs of abuse tests. 

You may search for additional product codes using the Classification database. To use this database, navigate: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm, type the name of the drug in the “Device” box, and select “Search.”

Reporting Problems to FDA

Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with a Drugs of Abuse Testing device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements should follow the reporting procedures established by their facilities. For more information, please see How to Report a Problem (Medical Devices)

What do these tests do? These tests indicate if one or more prescription or illegal drugs are present in urine. These tests detect the presence of drugs such as marijuana, cocaine, opiates, methamphetamine, amphetamines, PCP, benzodiazepine, barbiturates, methadone, tricyclic antidepressants, ecstasy, and oxycodone.

The testing is done in two steps. First, you do a quick at-home test. Second, if the test suggests that drugs may be present, you send the sample to a laboratory for additional testing.

What are drugs of abuse? Drugs of abuse are illegal or prescription medicines (for example, Oxycodone or Valium) that are taken for a non-medical purpose. Non-medical purposes for a prescription drug include taking the medication for longer than your doctor prescribed it for or for a purpose other than what the doctor prescribed it for. Medications are not drugs of abuse if they are taken according to your doctor’s instructions.

What type of test are these? They are qualitative tests -- you find out if a particular drug may be in the urine, but not how much is present.

Want more information on Drug Of Abuse Tests? Feel free to contact us.

When should you do these tests? You should use these tests when you think someone might be abusing prescription or illegal drugs. If you are worried about a specific drug, make sure to check the label to confirm that this test is designed to detect the drug you are looking for.

How accurate are these tests? The at-home testing part of this test is fairly sensitive to the presence of drugs in the urine. This means that if drugs are present, you will usually get a preliminary (or presumptive) positive test result. If you get a preliminary positive result, you should send the urine sample to the laboratory for a second test.

It is very important to send the urine sample to the laboratory to confirm a positive at-home result because certain foods, food supplements, beverages, or medicines can affect the results of at-home tests. Laboratory tests are the most reliable way to confirm drugs of abuse.

Many things can affect the accuracy of these tests, including (but not limited to):

• the way you did the test
• the way you stored the test or urine
• what the person ate or drank before taking the test
• any other prescription or over-the-counter drugs the person may have taken before the test

Note that a result showing the presence of an amphetamine should be considered carefully, even when this result is confirmed in the laboratory testing. Some over-the-counter medications will produce the same test results as illegally-abused amphetamines.

Does a positive test mean that you found drugs of abuse? No. Take no serious actions until you get the laboratory's result. Remember that many factors may cause a false positive result in the home test.

Remember that a positive test for a prescription drug does not mean that a person is abusing the drug, because there is no way for the test to indicate acceptable levels compared to abusive levels of prescribed drugs.

If the test results are negative, can you be sure that the person you tested did not abuse drugs? No. No drug test of this type is 100% accurate. There are several factors that can make the test results negative even though the person is abusing drugs. First, you may have tested for the wrong drugs. Or, you may not have tested the urine when it contained drugs. It takes time for drugs to appear in the urine after a person takes them, and they do not stay in the urine indefinitely; you may have collected the urine too late or too soon. It is also possible that the chemicals in the test went bad because they were stored incorrectly or they passed their expiration date.

If you get a negative test result, but still suspect that someone is abusing drugs, you can test again at a later time. Talk to your doctor if you need more help deciding what steps to take next.

How soon after a person takes drugs, will they show up in a drug test? And how long after a person takes drugs, will they continue to show up in a drug test? The drug clearance rate tells how soon a person may have a positive test after taking a particular drug. It also tells how long the person may continue to test positive after the last time he or she took the drug. Clearance rates for common drugs of abuse are given below. These are only guidelines, however, and the times can vary significantly from these estimates based on how long the person has been taking the drug, the amount of drug they use, or the person's metabolism.

How do you do a drugs of abuse test?

These tests usually contain a sample collection cup, the drug test (it may be test strips, a test card, a test cassette, or other method for testing the urine), and an instruction leaflet or booklet. It is very important that the person doing the test reads and understands the instructions first, before even collecting the sample. This is important because with most test kits, the result must be visually read within a certain number of minutes after the test is started.

You collect urine in the sample collection cup and test it according to the instructions. If the test indicates the preliminary presence of one or more drugs, the sample should be sent to a laboratory where a more specific chemical test will be used order to obtain a final result. Some home use kits have a shipping container and pre-addressed mailer in them. If you have questions about using these tests, or the results that you are getting, you should contact your healthcare provider.

Useful Links:

If you are looking for more details, kindly visit HAV Rapid Test.