QIAGEN WARNED FOR INCORRECT MARKETING OF ASRS
Qiagen inappropriately marketed several of its products as analyte-specific reagents (ASRs) and must apply for new FDA approvals, the agency said in a recent warning letter.
The agency said six Qiagen products could not be included in the ASR category because the company's marketing for the devices went "beyond the limits of the regulatory definition of an ASR." The warning letter, posted to the FDA website last week, followed an inspection of a Qiagen facility in Hamburg, Germany, July 10 13.
Qiagen marketed the products for direct sale to clinical laboratories, and not as parts to contribute to finished devices, according to the FDA. Because they were marketed as finished products, the agency considered them medical devices instead of ASRs.
The products also did not meet the criteria for ASRs because they were marketed as being able to detect more than one chemical substance, whereas ASRs detect only individual substances, the warning letter said.
Since artus CMV PCR, C. Trachomatis PCR, C. Trachomatis Plus PCR, Parvo B19 PCR, Borrelia PCR and Malaria PCR are no longer considered ASRs, they are subject to different rules and regulations as medical devices. The products were in violation of these rules, according to the warning letter.
Qiagen does not yet have an approved application for premarket approval, so all the products were considered adulterated, the FDA said, adding the devices were misbranded, because the company "did not notify the agency of [its] intent to introduce these devices into commercial distribution."
To correct the violations, Qiagen must resubmit its products for approval as medical devices, the FDA said.
Qiagen was changing its packaging and labeling before it received the letter, said Douglas Liu, the company's vice president of global operations. "We had been working towards making the corrections, and we believe that our proposals will meet the requirements of the regulations," he added. The company made a formal response to the FDA Oct. 19.
The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6046d.pdf (http://www.fda.gov/foi/warning_letters/g6046d.pdf).