| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesWARNING LETTER
VIA United Parcel Service
December 7, 2010
Jung-Shou Chen
President and CEO
BioCheck, Inc.
323 Vintage Park Drive
Foster City, California 94404
Dear Dr. Chen:
During an inspection of your firm located in Foster City, California between June 10, 2010 and July 20, 2010, our investigator determined that your firm manufactures in vitro diagnostic devices. In addition, you also manufacturer and distribute in vitro reagents identified for Research Use and Investigational Use. However, the product inserts for your Research and Investigational Use products include intended use statements, test, preparation, and calculation methods. With these additional intended uses, your Research and Investigational products are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), as 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. Our inspection revealed you are promoting and marketing these devices in violation of the Act. Our review of your promotional materials and labeling found the following statements for which FDA approval is required:
1. Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) Enzyme Immunoassay Test Kit
Your H-FABP product insert identifies it for "For Research Use Only". However, the product is intended for quantitative determination of Human Cardiac Fatty Acid-Binding Protein concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
Under INTRODUCTION, "[h]eart FABP (H-FABP) is a sensitive biomarker of myocardial necrosis that can be used to confirm or exclude a diagnosis of acute myocardial infraction (AMI) and for monitoring of a recurrent infarction." Your label further promotes, "H-FABP has been identified as a potential serum biomarker for stroke that is superior to either neuron specific enolase or $100B."
2. Prostate Specific Antigen (PSA) Enzyme Immunoassay Test Kit
Your PSA product insert identifies it "For Investigational Use Only". However, the product is intended for the quantitative determination of the Cancer Antigen PSA concentration in human serum.
Under INTRODUCTION, it reads "[r]eports have suggested that serum PSA is one of the most useful tumor markers in oncology. It may serve as an accurate marker for assessing response to treatment in patients with prostatic cancer."
3. Carcinoembryonic (CEA) Antigen Enzyme Immunoassay Test Kit
Your CEA product insert identifies it "For Investigational Use Only'. However, the product is intended for the quantitative determination of the Cancer Antigen CEA concentration in human serum.
Under INTRODUCTION, it reads "[i]ncrease levels of CEA are observed in more than 30% of patients with cancer of the lung, live, pancreas, breast, colon, head or neck, bladder, cervix, and prostate."
4. Rubella IgG Enzyme Immunoassay Test Kit
Your Rubella IgG ELISA insert identifies it "For Investigational Use Only". However, the product is intended for use in evaluating a patient's serologic status to the rubella virus infection.
Under INTRODUCTION, "[c]ongenital rubella may result in chronic cardiac disease, growth retardation hepatosplenomegaly, malfunctions and other severe anomalies. Children born asymptomatic may develop these abnormalities later in life. To reduce the risk of such severe complications, accurate serologic status of childbearing-aged women. The presence of rubella-specific IgG in the bloodstream attests immunity to rubella."
As a result of your product label, the above list of products are being marketed for a new intended use and are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (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 above list of devices is also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce those devices 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.
The FDA acknowledges your response to the list of inspectional observations. We find your response to FDA-483 Observations 1-3, and 5 to be adequate. We find your response to Observation 4 incomplete, as the investigation to this quality failure was not included in your response. In addition, the establishment of a written agreement for products not cleared by the FDA does not exempt you from distributing unapproved devices. We also acknowledge your voluntary action of recalling your Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) Enzyme Immunoassay Test Kit, and removing the diagnostic claims. Although we find this action acceptable for this product, your corrective action is incomplete as your Prostate Specific Antigen (PSA) Enzyme Immunoassay Test Kit, Carcinoembryornc (CEA) Antigen Enzyme Immunoassay Test Kit, and RubeIla IgG Enzyme Immunoassay Test Kit are being distributed with unapproved diagnostic claims and they remain in commercial distribution. FDA request that BioCheck immediately cease marketing, promoting, and distributing all in vitro diagnostic products that require PMA approval or 510(k) clearance without FDA approval or clearance. The adequacy of your corrective actions will be evaluated during our next inspection.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Federal agencies are advised of the issuance of all Waning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, which may include notification of your current and past customers. Your response should also include an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within I5 working days, state the reason for the delay and the time within which the corrections will be completed.
Additionally in your response, please indicate what you plan to do with existing stock and products in the field that have been previously shipped and are still in stock for which you lack PMA/IDE approval or 510(k) Clearance to market.
Your response should be sent to:
Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
If you have any questions about the content of this letter please contact Mr. Lawton W. Lum, Compliance Officer at (510) 337-6792.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to assure you obtain the necessary premarket clearance or premarket approval for the intended uses of all of your devices as defined by 21 CFR 801.4. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, Form FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Barbara J. Cassens
District Director
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