Inspections, Compliance, Enforcement, and Criminal Investigations
Immuno-Mycologies, Inc. 24-May-06
Department of Health and Human Services
Public Health Service
2098 Gaither Road
Via Federal Express
Sean Bauman, Ph.D.
1236 East Redbud Rd.
Goldsby, OK 73093
MAY 2 4 2006
Re: Immuno-Mycologics, Inc. ALPHA Histoplasma Antigen EIA Analyte Specific Reagent
Dear Dr. Bauman:
The Office of In Vitro Diagnostic Devices (OIVD) in FDA's Center for Devices and Radiological Health has reviewed information on your website, http://www.immy.com/index-2.html, about the product you market as ALPHA Histoplasma Antigen EIA Analyte Specific Reagent (ASRs). This review has revealed serious regulatory problems involving these devices manufactured by your firm.
The ALPHA Histoplasma Antigen EIA is a device, under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA or Act), [21 U.S.C. § 321(h)] because it is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease.
Your website identifies this product is an ASR. ASRs are defined as "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens." (21 CFR 864.4020(a)) ASRs are restricted devices under section 520(e) of the Act. Among the restrictions on ASRs is a requirement that advertising and promotional materials for ASRs may not "make any statements regarding analytical and clinical performance." (21 CFR 809.30(d)(4))
The package insert for the ALPHA Histoplasma Antigen EIA indicates that it contains, among other things, antibody coated microwells, positive control, standard curve reagents, wash buffer, detect antibody, streptavidin HRP, substrate, and stop solution. The package insert also provides detailed procedures with directions that are unique for this assay. These products do not meet the definition of an ASR. Moreover, based on information on your website, your device does not adhere to the restrictions on the sale, distribution, and use of ASRs.
A review of our records shows no clearance or approval for your ALPHA Histoplasma Antigen EIA test. Therefore, it is adulterated under section 501(f)(1)(B), [21 U.S.C. 351(f)(1)(B)], and misbranded under section 502(o), of the Act. [21 U.S.C. 352(o)] Your device is also misbranded under the Act because you did not submit a notice or other information about the device to FDA as required by section 510(k) of the Act. [21 U.S.C 360(k)] Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your device is also adulterated under the Act because the law requires, and you do not have, an approved application for premarket approval that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. (21 CFR 807.81(b)
This letter is not intended to be an all-inclusive list of deficiencies associated with your devices. It is your responsibility to ensure adherence to each requirement of the Act and regulations for every FDA-regulated product that you market. You are responsible for investigating and reviewing all materials to ensure compliance with applicable regulations.
You should take prompt action to correct these violations. Failure to correct these violations promptly may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to James Woods, Deputy Director of Patient Safety and Product Quality, Office of In Vitro Diagnostic Device Evaluation and Safety, 2098 Gaither Road, HFZ- 440, Rockville, Maryland 20850.
Steven I. Gutman, M.D., M.B .A.
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health