Medical Devices

Drugs of Abuse Tests

Introduction:
FDA regulates and reviews drugs of abuse tests before they can be sold to consumers or healthcare professional in the United States. 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.

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/K091612.pdf

http://www.accessdata.fda.gov/cdrh_docs/reviews/K091588.pdf

Doctor’s office or Drug Treatment Center 

http://www.accessdata.fda.gov/cdrh_docs/reviews/K080635.pdf

Lab-based

http://www.accessdata.fda.gov/cdrh_docs/reviews/K080057.pdf

http://www.accessdata.fda.gov/cdrh_docs/reviews/K102210.pdf

http://www.accessdata.fda.gov/cdrh_docs/reviews/K102210.pdf

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

Lab-based:

http://www.accessdata.fda.gov/cdrh_docs/reviews/K063024.pdf

Workplace:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm?db=pmn&id=K041747

Tests designed to be used with hair samples

OTC:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm?db=pmn&id=K080381

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. 

Common Test NameProduct CodeClassRegulation Number
amphetamineDKZ2862.3100
barbiturateDIS2862.3150
benzodiazepineJXM2862.3170
cannabinoidsLDJ2862.3870
cocaine and metabolitesDIO2862.3250
methadoneDJR2862.3620
methamphetamineLAF2862.3610
opiatesDJG2862.3650
phencyclidineLCM2862.3100
phenobarbitalDLZ2862.3660
propoxypheneJXN2862.3700
tricyclic antidepressantsLFG2862.3910

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.”

Guidance:
FDA has published a guidance document entitled Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff  that contains recommendations to consider when preparing a premarket submission for a drug test for FDA review.

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)