United States v. An Undetermined Number of Unlabeled Cases, Etc., Clinical Reference Laboratory, Inc., Claimant-Appellant

JOHN P. MOORE, Circuit Judge.

Clinical Reference Laboratory, Inc. appeals a grant of summary judgment holding certain urine and saliva specimen containers used in HIV-testing are adulterated “devices” subject to seizure pursuant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394. CRL contends the containers do not constitute devices within the meaning of 21 U.S.C. § 321(h) because CRL performs the tests for insurance risk assessment purposes and not for medical diagnosis. Also, CRL contests their designation as class III devices subject to premarket approval by the Food and Drug…