This article has been updated from a previous version to clarify Qiagen's current manufacturing and marketing arrangements and to include comment from the company.
NEW YORK (GenomeWeb News) — The US Food and Drug Administration has sent a letter to Qiagen warning it that certain of its molecular diagnostics currently manufactured in Hamburg, Germany, do not have regulatory approval for sale in the US.
In an Oct. 2 letter to Qiagen CEO Peer Schatz, the FDA said six diagnostic products manufactured at the Hamburg site are improperly marketed and require regulatory review by the agency. On its web site, Qiagen stresses that the products — tests for herpes virus, lime disease, parvovirus, Chlamydia, and malaria — are designed for use in CLIA labs and therefore do not require FDA oversight.
The FDA, on the other hand, claims that because the tests are packaged with instructions they are subject to agency review.
The products cited by the FDA letter include the artus CMV PCR, C. Trachomatis PCR, C. Trachomatis Plus PCR, Parvo B19 PCR, Borrelia PCR, and Malaria PCR analyte specific reagents.
According to a Qiagen spokesman, only two of the assays have been sold in the US, and their sales are “very immaterial.” He said the assays are based on older designs from artus, a molecular diagnostics manufacturer that Qiagen acquired last year for around $40 million.
The spokesman said that as part of the integration of artus, Qiagen “has already completed or initiated ensuring compliance” of the ASRs.
In its letter, available here, the FDA said it “has concluded that you market these products as ASRs for sale directly to clinical laboratories and not as components intended to be included as part of a finished, packaged, and labeled device as defined in 21 CFR 820.3(c).
“Our review has determined that these reagents are medical devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body,” the agency concluded.
The FDA goes on to say that the products “are not ASRs under 21 C.F.R. 864.4020 and require FDA premarket review prior to being marketed.”
The agency also noted that the tests “are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
“You should take prompt action to correct the violation(s) addressed in this letter,” the FDA concluded in the letter. “Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.
The Qiagen spokesman also stressed that the FDA’s letter implied “no issue with product quality,” and the ASRs manufactured at the Hamburg facility were produced using a complaint quality system.