What Must a DOT Oral Fluid Collection Device Include?

Under 49 CFR 40.49, each DOT oral fluid drug test uses a collection device that meets Appendix B to Part 40, titled Oral Fluid Collection Kit Contents. The kit includes the collection device, the manufacturer's instructions, a leak-resistant plastic bag, absorbent material and a shipping container.

Under Appendix B, the device is a single device that can be subdivided in the employee's presence into an "A" specimen and a "B" split specimen bottle sufficient for laboratory testing. It either collects enough oral fluid for an HHS-certified laboratory to analyze, for example by directing the oral fluid into two separate collection bottles, or uses a buffering solution with a single pad or dual pads joined for insertion together into the same region of the mouth. The volume specifications for a buffered device must be consistent with those set by HHS.

Appendix B also states that the device:

• Has unit markings or other indicators that show the adequacy of the volume collected
• Is transparent enough for a visual assessment of the contents without opening the specimen bottle
• Is individually packaged in an easily visible tamper-evident system
• Shows its expiration date on the specimen bottles sent to the laboratory, using the shortest expiration date of any component
• Has no components that substantially affect the drugs or drug metabolites in the specimen or interfere with accurate analysis
• Maintains the integrity of the specimen during storage and transport
• Accepts the CCF tamper-evident bottle seals without the seals concealing the expiration date
• Is approved by HHS for use by the specific HHS-certified laboratory that will test the specimen gathered by the device

Under Appendix B, the manufacturer's instructions are included in the packaging in sufficient detail to allow for an error-free collection. The HHS list of certified laboratories published in the Federal Register on September 30, 2026 states that no laboratories were certified at that time to conduct drug and specimen validity tests on oral fluid specimens.

Oral fluid cutoffs are covered in What Are the Cutoff Levels for a DOT Oral Fluid Drug Test?, collector training is covered in What Training Does a DOT Oral Fluid Collector Need?, and the urine kit is covered in What Must a DOT Urine Collection Kit Include?.

Learn Laws® offers DOT Oral Fluid Collector Training, an online DOT oral fluid collector course on the training and mock collections in 49 CFR 40.35.

On a few MyDrugTesting.com supplier profiles, the business address shown is a P.O. Box.