§ 40.91 What are the cutoff concentrations for oral fluid drug tests?
Current wording, effective June 1, 2023.
Non-evidentialAs alcohola screening testslaboratory, performedyou usingmust screeninguse devicesthe includedcutoff byconcentrations thedisplayed Nationalin Highwaythe Trafficfollowing Safetytable Administrationfor oninitial itsand conformingconfirmatory productsdrug listtests for nonoral 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-evidentialAcetylmorphine 4 screeningng/mL devices3 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., maytwo beor usedmore analytes that are in lieuthe 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 EBTsthe immunoassay to performthe screeningother testsanalyte(s) requiredwithin bythe operatinggroup administrations’must alcoholbe testing80 regulationspercent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate Non-evidentialtechnology: screeningEither devicesone mayanalyte notor all analytes from the group must be used for confirmationcalibration, alcoholdepending testson the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, whichalternatively, the sum of the analytes present (i.e., with concentrations equal to or greater than the laboratory's validated limit of quantification) must be conductedequal usingto EBTsor asgreater providedthan inthe subpartinitial Ctest ofcutoff.
2 thisAn partimmunoassay 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]
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.