Inspections, Compliance, Enforcement, and Criminal Investigations
Biolog, Inc. 06-Jun-07
Department of Health and Human Services
Public Health Service
2098 Gaither Road
JUN 6 2007
Barry R. Bochner, Ph.D.
President, CEO & CSO
21124 Cabot Blvd.
Hayward, CA 94545
Dear Dr. Bochner:
The Food and Drug Administration ( FDA) has learned that your firm is marketing the Biolog Microbial ID/Characterization Fully Automated System, which is intended for clinical and public health use to identify 1900 species of microorganisms, including Yersinia pestis, Bacillus anthracis, and Escherichia coli 0157:H7, in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, the Biolog Microbial ID/Characterization Fully Automated System is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
In prior communications with the FDA, you have indicated that you believe that your device is exempt from premarket review because you believe that it falls within the type of device classified into class I under 21 CFR 866.2660. As previously communicated to you by the Office of In Vitro Diagnostics (OIVD) in a letter dated February 5, 2007, and during a phone conference held on March 6, 2007, however, your device is not exempt from pre-market review due to several limitations in 21 CFR 866.9. We explain the application of these limitations to your device below, but the examples we give are not intended to be an exhaustive list of the aspects of your device that trigger the need for premarket review.
• Your device is not exempt from premarket notification, in accordance with 21 CFR 866.9(a), in that it has an intended use that is different from any legally marketed device currently classified under 21 CFR 866.2660. For example, your device is intended to identify organisms including Leclercia adecarboxylata, Pantoea agglomerans, and Riemerella anatipester which are not identified by any other legally marketed device and which may be new or novel strains where the performance characteristics and mechanisms of resistance are unknown.
• Your device is not exempt from premarket notification, in accordance: with 21 CFR 866.9(b), in that it operates using a different fundamental scientific technology than any legally marketed devices currently classified under 21 CFR 866.2660. Specifically, your promotional materials indicate that your device technology is based on "metabolic fingerprints" identified by "Biolog's proprietary carbon source utilization test methodology" which has not been used in any other legally marketed device that we are aware of.
• Your device is not exempt from premarket notification in accordance with 21 CFR 866.9(c)(3), in that it is intended for use in measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases. Although 21 CFR 866.9(c)(3) gives several examples, the list of named life-threatening diseases is illustrative, not exclusive. It is generally accepted that a number of the organisms that your device is intended to identify can cause life threatening diseases. For example, your device is intended to identify Yersinia pestis, which causes plague; Bacillus anthracis, which causes anthrax; and Escherichia coli 0157:H7, which causes infection which can lead to Hemolytic uremic syndrome, the cause of several deaths in recent outbreaks of food-borne illness.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, Biolog Microbial ID/Characterization Fully Automated System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have a PMA in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is 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 the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to: James L. Woods, Deputy Director, Patient Safety and Product Quality at the address above.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices . This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Steven I. Gutman, M.D., M.B.A.
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health
cc: Dr. Barry Bochner fax [redacted]