§ 40.91 What are the cutoff concentrations for oral fluid drug tests?
Current wording, effective June 1, 2023.
As a laboratory, when you conductmust validityuse testingthe undercutoff §concentrations 40displayed in the following table for initial and confirmatory drug tests for oral fluid specimens.89, youAll mustcutoff conductconcentrations itare expressed in accordancenanograms withper themilliliter requirements(ng/mL). ofThe thistable section.follows:
Initial test analyte Initial testcutoff 1 Confirmatory test analyte Confirmatory test cutoff concentration
Marijuana (aTHC) You2 4 mustng/mL determine3 THC 2 theng/mL.
Cocaine/Benzoylecgonine 15 creatinineng/mL CocaineBenzoylecgonine 8 concentrationng/mL.8 onng/mL.
Codeine/Morphine 30 eachng/mL CodeineMorphine 15 primaryng/mL.15 specimenng/mL.
Hydrocodone/Hydromorphone 30 Young/mL HydrocodoneHydromorphone 15 mustng/mL.15 alsong/mL.
Oxycodone/Oxymorphone 30 determineng/mL OxycodoneOxymorphone 15 itsng/mL.15 specificng/mL.
6-Acetylmorphine 4 gravityng/mL if3 6-Acetylmorphine 2 young/mL.
Phencyclidine 10 findng/mL Phencyclidine 10 theng/mL.
Amphetamine/Methamphetamine 50 creatinineng/mL AmphetamineMethamphetamine 25 concentrationng/mL.25 tong/mL.
MDMA be4/MDA less5 50 thanng/mL MDMAMDA 25 20ng/mL.25 mgng/dLmL.
1 For grouped analytes (b)i.e., Youtwo mustor determinemore analytes that are in the pHsame ofdrug eachclass primaryand specimen.have the same initial test cutoff):
(c
Immunoassay: YouThe test must performbe onecalibrated orwith moreone validityanalyte testsfrom forthe oxidizinggroup adulterantsidentified onas eachthe primarytarget specimenanalyte.ds) Youwithin the group must performbe additional80 validitypercent testsor ongreater; theif primarynot, specimenseparate whenimmunoassays must be used for the followinganalytes conditionswithin arethe observed:group.(1)Alternate Abnormaltechnology: physicalEither characteristics;one
(2)Reactionsanalyte or responsesall characteristicanalytes offrom anthe adulterantgroup obtainedmust duringbe initialused orfor confirmatorycalibration, drugdepending testson (ethe technology.g., non-recoveryAt ofleast internalone standards,analyte unusualwithin response);the group must have a concentration equal to or
(3)Possiblegreater unidentifiedthan interferingthe substanceinitial test cutoff or, adulterant.alternatively, the sum of the analytes present (i.e)., Ifwith youconcentrations determineequal thatto or greater than the specimenlaboratory's isvalidated invalidlimit andof HHSquantification) guidelinesmust directbe youequal to contactor greater than the MRO,initial youtest cutoff.
2 An immunoassay must contactbe calibrated with the MROtarget andanalyte.
3 togetherAlternate decidetechnology if(THC testingand the6-AM): primaryThe specimenconfirmatory bytest anothercutoff HHSmust certifiedbe laboratoryused wouldfor bean usefulalternate intechnology beinginitial abletest tothat reportis aspecific positivefor orthe adulteratedtarget testanalyte result(i.
[65FR2 79526,ng/mL Dec.for 19THC, 2000,2 asng/mL amendedfor at6-AM).
4 69Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).
[88 FR 6486727643, Nov.May 92, 20042023]
As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests for oral fluid specimens. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:
| Initial test analyte | Initial testcutoff 1 | Confirmatory test analyte | Confirmatory test cutoff concentration |
|---|---|---|---|
| Marijuana (THC) 2 | 4 ng/mL 3 | THC | 2 ng/mL. |
| Cocaine/Benzoylecgonine | 15 ng/mL | CocaineBenzoylecgonine | 8 ng/mL.8 ng/mL. |
| Codeine/Morphine | 30 ng/mL | CodeineMorphine | 15 ng/mL.15 ng/mL. |
| Hydrocodone/Hydromorphone | 30 ng/mL | HydrocodoneHydromorphone | 15 ng/mL.15 ng/mL. |
| Oxycodone/Oxymorphone | 30 ng/mL | OxycodoneOxymorphone | 15 ng/mL.15 ng/mL. |
| 6-Acetylmorphine | 4 ng/mL 3 | 6-Acetylmorphine | 2 ng/mL. |
| Phencyclidine | 10 ng/mL | Phencyclidine | 10 ng/mL. |
| Amphetamine/Methamphetamine | 50 ng/mL | AmphetamineMethamphetamine | 25 ng/mL.25 ng/mL. |
| MDMA 4/MDA 5 | 50 ng/mL | MDMAMDA | 25 ng/mL.25 ng/mL. |
| 1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): | |||
| Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group. | |||
| Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., with concentrations equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff. | |||
| 2 An immunoassay must be calibrated with the target analyte. | |||
| 3 Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM). | |||
| 4 Methylenedioxymethamphetamine (MDMA). | |||
| 5 Methylenedioxyamphetamine (MDA). |
[88 FR 27643, May 2, 2023]
Amendment history
5 distinct wordings on file since Oct. 1, 1996- [88 FR 27643, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000
A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section. Set a case date in the header to read any earlier wording.