First, start with the definitions.A device for self-testing means any device intended by the manufacturer to be able to be used by lay persons in a home environment.Specimen receptacles are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.I think it is clear that the device you describe satisfies the definition of a specimen receptacle.I don't think it satisfies the definition of self-testing because the user doesn't get the result in the home environment, i.e., your device doesn't perform a test.Consider, as an example, a home use blood glucose test. It involves three devices. There is a lancet to draw blood, a test strip to collect the blood, and a glucometer that tests the blood and delivers the result. The result is produced in the home.By analogy, you have only one device. There is no equivalent to the lancet. The sponge and tube collect, hold, and preserve the sample. The instrument that analyses the sample and delivers the result is in the lab, not the home.I conclude that you have a specimen receptacle only.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
email@example.com+1 301 770 2920
JoinMy RAPS DashboardLearn More