Document issued on: August 23, 2000
U.S. Department Of Health And Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Division of Clinical Laboratory Devices
Office of Device Evaluation
Comments and suggestions may be submitted at any time for Agency consideration to Elizabeth Stafford, Center for Devices and Radiological Health. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Elizabeth Stafford at (301) 796-6184 or by email at email@example.com.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number (1183) to identify the guidance you are requesting.
Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications
On August 16, 2000, FDA classified Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) in vitro diagnostic devices from Class III designation to Class II. This guidance document describes a means by which anti-S. cerevisiae antibody (ASCA) devices may comply with the requirements of class II special controls. Designation of this guidance document as a special control means that manufacturers of anti-S. cerevisiae antibody devices, who follow the recommendations listed in this document before introducing their device into commercial distribution in the United States, will be able to market their device after they have submitted a premarket notification submission, referred to as a 510(k), and received a finding of "substantial equivalence" for their device. The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.
FDA identifies this generic type of device as an immunological device under 21 CFR §866.5785, product code NBT. This generic type of device, an anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) device is used for the semi-quantitative measurement of antibodies to S. cerevisiae (baker’s and brewer’s yeast) as an aid in the diagnosis of Crohn’s disease.
Risks to Health
FDA has identified two risks to health associated with this type of device. These risks involve: 1) a falsely elevated result leading to a medical decision causing a patient to undergo needless therapy or an unnecessary change in treatment; or 2) a falsely low result delaying recognition by the physician of the presence or progression of disease causing treatment to be delayed.
Special Controls Guidance
FDA believes the following controls, when combined with the general controls of the Food Drug and Cosmetic Act, will provide reasonable assurance of the safety and effectiveness of this type of device: labeling, design controls, and clinical information.
- The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR §801.109.
- Labeling in accordance with 21 CFR §809.10 (b). In addition, labeling should:
- support statements throughout the document with literature citations
- include an intended use statement with test methodology, specimen type, and whether the assay is qualitative or semi-quantitative
- include a summary of results from the clinical studies
- include quality control recommendations
- give an adequate description of the interpretation of results and expected results (incidence of ASCA in normal and diseased populations)
- include special limitations of the assay, e.g. restrictions in the pediatric population; the significance of a positive or negative result; use of the stated sample matrix only; etc.
- Clinical information in the submission should demonstrate:
- the sensitivity in the target population
- specificity in other gastrointestinal disease and in healthy, non-diseased groups
- incidence of ASCA in all groups studied
- Analytical/Laboratory performance studies should include:
- validation of the cut-off
- prevalence in the asymptomatic population
- assay specificity/interfering substances
- reproducibility at the cut-off and over the reportable range of the assay
- antigen characterization
- method and reagent description
- Copies of current literature to support the use of ASCA in the diagnosis of Crohn’s disease
For additional information refer to the following FDA guidance documents:
- Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions.
- Review Criteria for Assessment of Rheumatoid Factor (RF) in vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA) Enzyme-Linked Immunosorbent Assay (ELISA) Particle Agglutination Tests and Laser and Rate Nephelometry.
- Review Criteria for in vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoassay (RIA), and Enzyme-Linked Immunosorbent Assay (ELISA).
These documents are available on the Internet as shown or from CDRH-Division of Industry and Consumer Education (DICE) at its toll-free number 1-800-638-2041 or 301-796-7100; or email: DICE@fda.hhs.gov
FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device, and therefore, the device type is not exempt from the premarket notification requirements. Thus, persons who intend to market a device of this type need to submit a premarket notification to FDA and receive agency clearance prior to marketing the device.