Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 26, 2013 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.