11 Panel Drug Test: What It Screens, Typical Cutoffs and When Employers Choose It

11 Panel Drug Test: What It Screens, Typical Cutoffs and When Employers Choose It

An 11 panel drug test cup is a step up from the more common 5 and 10 panel configurations, built for programs that want visibility into a wider mix of prescription opioids, sedatives and club drugs in a single cup. The exact analyte list is set by the manufacturer and printed on the box, and configurations vary between suppliers, so the box label governs, not any general description in an article like this one.

This post covers what an 11 panel cup typically screens, how screening cutoffs work, what CLIA waived status means for the product class, and when employers, treatment programs and supervision agencies tend to choose an 11 panel configuration over a 5, 10, 12 or 13 panel cup.

What an 11 panel drug test cup typically screens

Across common commercial configurations, an 11 panel urine cup typically covers amphetamines, barbiturates, benzodiazepines, cocaine, methamphetamine, MDMA, methadone, opiates, oxycodone, phencyclidine and THC. Some 11 panel configurations swap one of those analytes for buprenorphine or propoxyphene depending on what the buyer requests, so the drug list on the actual product packaging is the only reliable reference for what a specific cup detects.

Abbreviation Drug class or substance Typical screening cutoff
AMP Amphetamine 1,000 ng/mL
BAR Barbiturates 300 ng/mL
BZO Benzodiazepines 300 ng/mL
COC Cocaine metabolite 150 or 300 ng/mL
mAMP Methamphetamine 500 or 1,000 ng/mL
MDMA Ecstasy 500 ng/mL
MTD Methadone 300 ng/mL
OPI Opiates (morphine/codeine) 300 or 2,000 ng/mL
OXY Oxycodone 100 ng/mL
PCP Phencyclidine 25 ng/mL
THC Marijuana metabolite 50 ng/mL

These numbers are the commonly used screening cutoffs across the rapid cup product class and vary by manufacturer and lot. They are not a promise of what any single product detects. Buyers should confirm cutoffs against the package insert for the specific lot they purchase.

Where the cutoffs come from

Only part of an 11 panel cup overlaps with the drugs covered by the federal workplace testing program. The Department of Health and Human Services, acting through the Substance Abuse and Mental Health Services Administration, sets Mandatory Guidelines for Federal Workplace Drug Testing Programs that establish initial and confirmatory cutoffs for the drugs federal agencies and some federally regulated employers must test for, commonly called the federal five: marijuana metabolite, cocaine metabolite, phencyclidine, amphetamines and opioids. Those guidelines, along with the certification standards for the laboratories that run confirmation testing, are published by SAMHSA and in the Federal Register notice of the Mandatory Guidelines for Federal Workplace Drug Testing Programs. SAMHSA's workplace program page is the starting point for the current guidance and certified laboratory list, available at samhsa.gov/workplace.

The other analytes on an 11 panel cup, including barbiturates, benzodiazepines, methadone, MDMA and oxycodone, are not part of the federally mandated five. Their screening cutoffs follow product class norms set by the manufacturer rather than a single federal rule, so cutoffs for those analytes can differ from one cup brand to the next. Employers who need a specific cutoff for a non federal five analyte should request it in writing from the manufacturer rather than assuming it matches another product.

CLIA waived status

Most single use, visually read urine drug test cups sold for point of care use, including common 11 panel configurations, are categorized under the Clinical Laboratory Improvement Amendments program as CLIA waived for the specific analytes listed on that product's clearance. CLIA waived status means the test has been reviewed and determined simple enough, with a low risk of an incorrect result, for use outside a traditional clinical laboratory setting, under rules administered by the Centers for Medicare and Medicaid Services. CMS describes the CLIA program and waived testing requirements at cms.gov, and the FDA maintains the current list of CLIA waived analytes and the products cleared for each one at accessdata.fda.gov. Buyers should confirm CLIA waived status against the specific product's own clearance rather than assuming every analyte on an 11 panel cup carries it, and no drug test cup should be described with that phrase. The correct term for the product class, when accurate for a given product, is CLIA waived or FDA cleared.

Screening result versus confirmation

An 11 panel cup is an immunoassay screening device. It gives a preliminary result, not a legally or medically conclusive one. Any non negative screening result, meaning any line pattern that reads as positive for one or more analytes, should be sent to a certified laboratory for confirmation testing using gas chromatography mass spectrometry or liquid chromatography mass spectrometry. Confirmation testing identifies the specific substance and quantity rather than relying on the cross reactivity of a screening antibody. In regulated and many employer programs, a medical review officer reviews any confirmed non negative result, contacts the individual, and considers valid prescriptions or other legitimate medical explanations before a result is reported as verified. No screening cup result should be treated as a final determination of drug use without that confirmation and review step.

How an 11 panel compares to other panel sizes

Configuration Typical scope Common use case
5 panel The federal five analytes only DOT safety sensitive and federally regulated testing
10 panel Federal five plus common sedatives and opioids General pre employment and random workplace programs
11 panel 10 panel scope plus one added analyte such as oxycodone, MDMA or buprenorphine Treatment programs, probation or court ordered testing, staffing agencies wanting broader opioid coverage
12 panel 11 panel scope plus an additional analyte, configuration dependent Programs tracking a wider range of prescription and illicit opioids
13 panel Broadest common cup configuration before synthetic drug add ons Higher risk populations, expanded opioid and sedative monitoring

The practical difference between an 11, 12 and 13 panel cup is usually one or two added analytes, most often additional opioids, buprenorphine, or a club drug like MDMA. For a closer look at how the next sizes up are built, see 12 Panel Drug Test: What It Tests For, Cutoff Levels and When Employers Choose It and Whats on a 13-Panel Drug Test. For programs that only need the federal five plus a handful of common opioids and sedatives, the smaller 10 panel configuration may cover the same risks at lower cost.

When employers and programs choose an 11 panel configuration

An 11 panel cup tends to fit programs that need more opioid and sedative visibility than a standard 10 panel but do not need the broadest commercially available configuration. Substance use treatment programs often want the added analyte to track a specific drug relevant to a client's history. Probation, parole and other court ordered testing programs may select an 11 panel cup when a supervising agency specifies a drug list that a 10 panel does not fully cover. Staffing agencies and employers in industries with documented opioid diversion risk sometimes move up from a 10 panel to an 11 panel cup to add oxycodone or buprenorphine coverage without jumping to the largest available panel size. The right configuration in each case depends on the population being tested and any contract, grant or court requirements that specify exact analytes, and employers should confirm those requirements before ordering rather than assuming a larger panel number automatically satisfies them.

Frequently asked questions

What does an 11 panel drug test screen for?

Configurations vary by manufacturer, but an 11 panel urine cup commonly screens for amphetamine, barbiturates, benzodiazepines, cocaine metabolite, methamphetamine, MDMA, methadone, opiates, oxycodone, phencyclidine and THC. Some configurations substitute buprenorphine or propoxyphene for one of those analytes. The drug list printed on the product packaging is the only reliable reference for a specific box.

Is an 11 panel drug test approved by FDA?

Drug test cups are not described with that phrase. The accurate terms, when they apply to a specific product, are CLIA waived for point of care use or FDA cleared for the analytes listed on that product's clearance. Buyers can check the current CLIA waived analyte list maintained by the FDA.

How are the cutoff levels for an 11 panel cup set?

Cutoffs for the federal five analytes, which overlap with part of an 11 panel cup, come from SAMHSA's Mandatory Guidelines for Federal Workplace Drug Testing Programs. Cutoffs for the remaining analytes on an 11 panel cup, such as barbiturates, benzodiazepines, methadone and oxycodone, follow manufacturer and product class norms rather than a single mandated federal cutoff.

Does a positive result on an 11 panel cup mean the person used drugs?

No. A positive or non negative cup result is a preliminary screening finding only. It should be sent to a certified laboratory for confirmation testing by gas chromatography mass spectrometry or liquid chromatography mass spectrometry, and a medical review officer should review any confirmed result and consider valid prescriptions before it is reported as verified.

How is an 11 panel different from a 10 or 12 panel cup?

An 11 panel cup typically adds one analyte beyond a standard 10 panel configuration, often oxycodone, MDMA or buprenorphine. A 12 panel cup usually adds one more analyte beyond that. The specific difference depends on each manufacturer's configuration, so the printed drug list on each product is the way to compare them.

Who typically uses an 11 panel drug test?

Substance use treatment programs, probation and court ordered supervision programs, and staffing agencies or employers wanting broader opioid and sedative coverage than a standard 10 panel cup are common users of the 11 panel configuration.

Employers and programs that want to compare panel configurations and order CLIA waived cups can review the drug test cup collection on americanscreeningcorp.com.

This article is general information about drug test panel configurations and screening science. It is not legal or medical advice. Employers and programs should confirm exact analyte lists and cutoffs against the product packaging and consult qualified counsel or a medical review officer for program specific decisions.

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