Comment from ARK Diagnostics, Inc.
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Summary: ARK Diagnostics supports the proposed expansion of Class II 510(k) exemptions for certain clinical toxicology test systems used in employment and insurance testing. They argue the proposal reduces unnecessary regulatory burdens for well-established assays and request further clarification on the scope regarding fentanyl assays and labeling requirements.
FDA Docket No. FDA-2026-N-4268
ARK Diagnostics supports the proposed expansion of the Class II 510(k) exemptions for certain clinical toxicology test systems intended for employment and insurance testing, including use in Federal drug testing programs.
This proposal appropriately reduces unnecessary regulatory burden for well-established toxicology assay categories where device characteristics, risks, and performance expectations are well understood. Expanding the exemption to include Federal drug testing programs will help streamline availability of these assays.
ARK also requests clarification regarding the scope of the exemption as it relates to fentanyl assays. Specifically, 21 CFR 862.3650 (Opiate Test System) includes non-exempt product code DJG in Table 1 of the notice. FDA should clarify whether fentanyl test systems currently regulated under product code DJG would fall within the proposed exemption framework if intended solely for employment and insurance testing, including Federal drug testing programs.
Additional clarification regarding the expected labeling language for exempt devices intended for Federal workplace drug testing programs would also be helpful.