Rapid Drug Test Kit Certifications: What Do They Mean?
For companies wanting to bring drug testing in-house or for establishments who want to offer drug testing as part of a service, finding the right rapid drug test kit is integral to an accurate and reliable testing program.
There are also state and oftentimes local testing regulations that dictate the drug testing methods that can be used and drug panels that can be tested. Also in the decision mix are various test kit approvals or certifications that limit when, where, and by whom that test kit can be used. This article breaks down the various drug testing kit approvals and certifications so that you know the difference and can have the information needed to make the best decision on which test kit meets your organization’s program needs.
FDA 510(k) cleared vs OTC
The Food and Drug Administration (FDA) has various certifications or approvals they issue that denote how a product is approved for use and where and how it can be marketed. Rapid or instant drug test kits often found on pharmacy shelves are typically approved by the FDA for over-the-counter use. This means that the test is safe and simple enough to be used by the public and does not require special instrumentation or professional acumen when administering a test or interpreting test results. While these test kits are fine for parents needing to know if their child is taking drugs, they may not be as accurate as kits marked for professional use and must never be used for workplace testing.
Drug test kits that undergo an FDA 510(k) pre-market submission wish to demonstrate that the testing device is not only safe and effective in their use, but are significantly comparable to a legally marketed medical device, making them far more reliable and accurate. Test results obtained by using a drug test kit marked FDA 510(k) cleared will stand up in a court of law and are typically used by testing professionals in a medical or clinical setting. Your state or local drug testing laws may allow for the use of an FDA 510(k) cleared drug test kit if it is administered by a medically trained professional.
E&I Exempt
E&I Exempt is another category of rapid drug test kits that are intended for employment and insurance testing. Test kits falling under this category means they are exempt from FDA clearance and are therefore exempt from premarket notification requirements and stringent commercial marketing requirements. E&I Exempt test kits should only be used for non-federal workplace testing purposes, when testing employees or for insurance testing purposes. Test kits should be clearly marked E&I Exempt to use them for workplace drug testing. These test kits are also ideal for employment agencies offering pre-employment or regular drug screening of their applicants.
E&I Exempt test kits typically use immunoassay technology and come in fixed panel combinations that screen for common drug classes. Most panels include substances like amphetamines, cocaine, opiates, PCP, and THC, with some kits also covering benzodiazepines, barbiturates, methadone, MDMA, or oxycodone. Because these kits are designed for basic employment and insurance screening, they usually offer fewer drug combinations than fully FDA-cleared devices and provide preliminary results that may require confirmation by a laboratory.
CLIA Waived
Clinical Laboratory Improvement Amendments (CLIA) is an organization that establishes quality standards for all laboratory settings to ensure accuracy, reliability, and promptness of patient test results. The FDA categorizes commercially marketed tests into one of three CLIA categories: waived tests, tests of moderate complexity, and tests with high complexity. Drug test kits under a CLIA Waived category are the least complex to use and can easily be administered by an untrained person not in a laboratory setting but are typically marketed for professional use. These drug test kits do not require highly trained laboratory personnel to administer the test, nor do they require laboratory quality control testing.
Many states allow the use of CLIA Waived kits for workplace testing. However, companies must first obtain a CLIA Certificate of Waiver from the centers for Medicare and Medicaid Services to use one. Despite being simple to use, CLIA regulations require this certificate of waiver to legally perform them and take measures to ensure the instructions are properly and consistently followed.
Many CLIA Waived drug test kits can be sent to a laboratory for confirmation testing should the initial screening test result in a non-negative outcome.
Forensic Use
Drug test kits labeled Forensic Use Only are not FDA-cleared for medical diagnosis and cannot be used in standard workplace drug-testing programs. These kits are intended for non-clinical, non-diagnostic applications, including law enforcement, corrections, probation, court-ordered testing, and certain investigatory or legal purposes. In some cases, Forensic Use Only devices may also be used by private organizations or institutions that need non-clinical drug screening, as long as it is not part of a regulated workplace program. Forensic-use drug test kits often include drug panels or lower cutoff levels that are not allowed in workplace testing, which allows for detection at smaller concentrations and may result in more non-negative or presumptive positive findings.
Testing Methods
It’s important to reference your state and local laws to know what testing methods can be used in non-regulated workplace testing programs and what drug panels can be tested. For example, most states allow for the use of urine and oral fluid as a testing method. While hair, fingernail, blood draws or sweat patches are forbidden. Most states allow for the use of hair follicle testing or testing using fingernail cuttings or sweat patches in a forensic application only, where testing is court-ordered.
States like California and Colorado have enacted recent laws forbidding non-regulated employers from testing for THC. Third party administrators (TPAs and CTPAs) specializing in the drug and alcohol testing industry have knowledge of what is and isn’t allowed at state and local levels and are available to consult companies to provide comprehensive drug and alcohol testing policies and program guidelines that are compliant.
Are 510(k) Cleared, E&I, CLIA-Waived, and Forensic-Use-Only all the same? The simple answer is No – these are different categories of drug-testing devices, each meant for different situations. A drug test kit can fall into only one of these categories because each category has different rules and intended uses.
To recap:
510(k) Cleared tests are the devices that have gone through the FDA’s review process.
• Reviewed and cleared by the FDA.
• Intended for clinical or medical use, and sometimes workplace testing depending on state rules.
• Often used by hospitals, clinics, and professional testing providers.
On the other hand, E&I Exempt (Employment & Insurance) tests are not FDA-cleared at all – and that’s by design.
• NOT FDA-cleared on purpose.
• Only meant for non-federal workplace or insurance drug testing.
• Must be clearly labeled E&I Exempt.
• Cannot be used for DOT or medical diagnostic purposes.
Then there are CLIA-Waived tests, which are simple enough to be performed in doctors’ offices, clinics, or any healthcare setting that holds a CLIA waiver.
• Tests simple enough for use in doctors’ offices or clinics with a CLIA waiver.
• Still regulated as medical tests.
• Used in healthcare settings, sometimes in workplace testing if allowed by state law.
Finally, you have Forensic Use Only (FUO) devices. These tests are not FDA-cleared for medical purposes and are meant strictly for legal and investigative settings such as law enforcement, probation, corrections, or court-ordered testing. They are not appropriate for general employment screening or clinical use.
• Not FDA-cleared for medical diagnosis.
• Intended strictly for law enforcement, coroners, probation, or criminal justice testing.
• Not appropriate for employment or clinical use.
So how do you know which one to choose? It all comes down to the use case. Medical or clinical testing requires a 510(k) Cleared or CLIA-Waived device. Workplace and insurance testing calls for E&I Exempt kits. Anything involving criminal justice or legal investigations must use Forensic Use Only products.
Manufacturers make this easier by clearly labeling their devices. Look for markings like FDA 510(k) Cleared, E&I Exempt, CIA-Waived, or Forensic Use Only on the packaging or product sheets. If the label isn’t obvious, the instructions for use or product listing will tell you exactly which category the device falls into.
With the right information, choosing the proper drug test kit becomes much simpler – just match the device category to your testing purpose, and you’re set.