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:
Table 1 to § 40.91—Oral Fluid Testing Cutoff Concentrations
| Initial test analyte | Initial test cutoff 1 | Confirmatory test analyte | Confirmatory test cutoff concentration |
| Marijuana (THC) 2 | 4 ng/mL 3 | THC | 2 ng/mL. |
| Cocaine/Benzoylecgonine | 15 ng/mL | Cocaine Benzoylecgonine | 8 ng/mL. 8 ng/mL. |
| Codeine/Morphine | 30 ng/mL | Codeine Morphine | 15 ng/mL. 15 ng/mL. |
| Hydrocodone/Hydromorphone | 30 ng/mL | Hydrocodone Hydromorphone | 15 ng/mL. 15 ng/mL. |
| Oxycodone/Oxymorphone | 30 ng/mL | Oxycodone Oxymorphone | 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 | Amphetamine Methamphetamine | 25 ng/mL. 25 ng/mL. |
| MDMA 4/MDA 5 | 50 ng/mL | MDMA MDA | 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).
Source: 88 FR 27643, May 2, 2023
Compiled from the Electronic Code of Federal Regulations (eCFR), an editorial compilation and not an official legal edition of the CFR. The official text is the Federal Register and the annual CFR edition. §40.91 on eCFR.