Toxicology Associates, Columbus, OH, May 15 (CDRH).

CDRH's OIVD reviewed information on the firm's website regarding the Quidel Quick Vue Influenza A/B, Quidel QuickVue Strep A, and Quidel QuickVue+Infectious Mononucleosis tests and determined the products were being marketed as devices because they were promoted as intended for use in the diagnosis or treatment of disease

The subject tests were only cleared by FDA for the professional and laboratory use, CDRH emphasized. The Quidel QuickVue Influenza A/B Test is intended for the rapid, qualitative detection of influenza Types A and B antigen directly from nasal swab, nasal wash and/or nasal aspirate specimens.

The Quidel QuickVue In-Line Strep A Test allows for the rapid detection of Group A Streptococcal antigen directly from the patient throat swab specimens.

And, the Quidel QuickVue+ Infectious Mononucleosis test is a rapid color immunochromatographic assay for the detection of Infections Mononucleosis IgM heterophile antibodies in whole blood.

However, the information on Toxicology Associates's website indicates the firm was marketing the devices for OTC sales directly to the public--an action for which the company does not have a PMA in effect. The agency also objected to the firm's product labeling, which stated that the tests at issue had been approved by FDA.

Lastly, OVID noted that it had made several attempts to contact Toxicology Associates--on Jan. 9, March 8 and April 3--but the company had neither replied nor taken any corrective actions. CAPA, Lab, PMA, Web; Doc. 13799W