FDA WARNING_LETTER - LumiQuick Diagnostics Inc. - December 07, 2012

On July 31, 2013, the FDA issued a Warning Letter to LumiQuick Diagnostics, Inc. following an inspection from November 26 to December 7, 2012. The inspection revealed that the firm's QuickView PSA, Syphilis Antibody, Rotavirus Antigen, and Troponin I Test Cards are adulterated and misbranded.

Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act because LumiQuick Diagnostics, Inc. lacks approved premarket approval (PMA) applications or investigational device exemptions. They are also misbranded under section 502(o) for failure to submit premarket notifications (510(k)s). The QuickView Rotavirus Antigen Test Card, in particular, exceeds the exemption limitations under 21 CFR 866.9(c)(6), making it an unapproved Class III device.

Furthermore, the devices are misbranded under section 502(t)(2) due to the firm's failure to establish adequate Medical Device Reporting (MDR) procedures, violating 21 CFR 803.17. The firm's submitted SOP-814 was deemed inadequate as it did not address timely identification, evaluation, and transmission of MDR events, nor documentation requirements.

The FDA requires prompt corrective action within fifteen business days, including a detailed plan to prevent recurrence and