## Facts

- A clinical laboratory designed HIV-1 antibody testing using urine and saliva specimens rather than blood or serum.
- The laboratory purchased ordinary specimen containers, repackaged them into testing “kits” with instructions and forms, distributed kits to insurers, and tested collected specimens.
- The laboratory reported HIV results to insurers as “non-reactive” or “inconclusive” for underwriting decisions.
- The FDA treated the repackaged specimen containers as regulated “devices” used for HIV testing and asserted that distributing them without required premarket approval rendered them “adulterated.”
- The United States filed an in rem FDCA seizure action against shipments of the unlabeled cases of containers; the laboratory appeared as claimant.

## Issues

1. Whether specimen containers repackaged as part of HIV test kits are “devices” under 21 U.S.C. § 321(h) when used for insurance underwriting rather than clinical treatment.
2. Whether the containers were properly treated as class III devices requiring premarket approval, such that lack of approval made them “adulterated” under 21 U.S.C. § 351(f) and subject to seizure.

## Decision

- The court affirmed that the specimen containers, as components intended for HIV antibody detection, are FDCA “devices.”
- The court reversed the ruling that the containers were class III devices requiring premarket approval.
- Because class III status was not supported on this record, the government could not treat the containers as “adulterated” solely due to absence of premarket approval.
- Disposition: affirmed in part and reversed in part.

## Legal Principles

- FDCA “device” status turns on objective evidence of intended use, including labeling, instructions, and the product’s role in detecting disease.
- A product can be “intended for use in the diagnosis of disease” even if the test results are used for non-therapeutic decisions (e.g., insurance underwriting).
- Regulatory jurisdiction (device status) is distinct from the level of regulatory control (device classification).
- Condemnation for adulteration under § 351(f) requires a valid basis for a premarket-approval requirement (such as a properly supported class III classification).

## Conclusion

The Tenth Circuit held that specimen containers packaged for HIV antibody testing fall within the FDCA’s device definition despite their use in insurance screening, but rejected seizure premised on an unsupported determination that the containers were class III devices requiring premarket approval.


United States v. An Undetermined Number of Unlabeled Cases, 21 F.3d 1026 (10th Cir. 1994)