Comment from Jane Zhang

It is understandable that FDA has considerations about whether Class II drugs of abuse test devices should be exempt from 510k, is to have sufficient data/information to provide reasonable assurance of safety and effectiveness of the device. Comment 1 with Section IV. List of Class II Devices: We support NDASA’s advocacy. However, one question and concerns in section IV, with regarding to Opiate Test System with Exempt Code: PVH: 1.In Table 1, Opiate Test System with Exempt Code: PVH in Table 1—Proposed Exempt Class II Devices Subject to General Limitations and Partial Limitation. In Proposed partial limitations, a statement “Exemption is limited to test systems intended to measure any of the addictive narcotic pain-relieving opiate drugs…” The question is whether all the following drug tests of the Common Addictive Opioid Drugs (Narcotics) are included in the 510(k) exempt (Exempt Code: PVH) category for urine and oral fluid tests? Fentanyl, Oxycodone, Hydrocodone, Morphine, Codeine, Hydromorphone, Methadone, Oxymorphone, Tramadol, Meperidine, Meperidine and Buprenorphine. 2.Concerns: Not like the SAMHSA mandate drug tests, there is no government and industry recognized cut off for Fentanyl/Norfentanyl tests. The cut off level sittings are varied from Lab-to-Lab for LC-MS/MS or GC/MS confirmatory assays. Particularly, Isomers: LC-MS/MS still faces challenges in distinguishing between specific isomers. As new analogs emerge, labs must update the methods, in order to effectively detect unknown compounds. GCMS may not be sensitive enough for some analogs, and Confirmation positivity rates vary. Fentanyl analogs have been considered “legal highs”. The risk of legal consequences should be taken into the considerations for Opiate test system including Fentanyl/norfentanyl test to be exempt. RECOMMENDATION: The exemption for Opiate drug tests should not include class Fentanyl drugs at the present time. Jane Zhang, Chemtron Biotech, Inc.Date: May-26-2026