US BioTek has developed and determined the performance characteristics of its assays. These in-house assays have not been cleared or approved by the U.S. Food and Drug Administration (“FDA”) and are considered for investigational and research purposes only. The FDA does not require these types of in-house testing to go through pre-market FDA review.
Quantification of specific IgE antibodies to foods and inhalants is an FDA-accepted diagnostic procedure for the assessment of allergies. However, the assessment of human IgG or IgA antibodies specific for individual food and inhalent antigens is not an FDA-recognized diagnostic indicator of allergy. While still primarily a research and investigation tool, specific IgG quantification has been utilized in research settings to assess and investigate Type I and Type III allergies, respectively. The FDA considers IgG or IgA testing to be of an investigational or research nature and does not consider clinical data to be conclusive for the use of such testing in the diagnosis of food allergies.
US BioTek makes no claims as to the diagnostic or therapeutic use of its tests or other informational materials. US BioTek is not responsible or liable for misuse or misinterpretation of the information provided, or any diagnoses or healthcare changes initiated by a patient or a healthcare practitioner based on the content of US BioTek’s informational materials. Not all insurers may provide coverage for these tests.
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