Palmetto GBA Test Identifier (PTI) Application Guide

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Palmetto GBA Test Identifier (PTI) Application GuideFDA FieldsField NameFDA (510k/PMA)FDA Document #Modifications to FDACleared / ApprovedProtocolsDescription Column entry is required. Indicate, via the dropdown options, if the test/assay is FDA510(k) cleared and/or has FDA pre-market approval, or ispending decision by the FDA. Acceptable format: Y/N/P. This information will be exposed to public view. Column is required ONLY if previous column = "P" (pending) inprevious column response. Indicate the FDA document number if the test/assay is beingevaluated for FDA 510(k) clearance or FDA pre-marketapproval. Acceptable format: alphanumeric. This information will be exposed to public view. Column is optional but strongly recommended if FDA(510k/PMA) = Y or P. Indicate, via the dropdown options, if the test/assay hasmodifications to FDA 510(k)/PMA protocols. Acceptable format: Y/N. Confidential: This information will not be exposed to public view.Instructions FieldsField NameSpecimen InstructionsHandling InstructionsDescription Column entry is required. Briefly specify all types of specimens that are accepted for thetest/assay. Acceptable format: free-text entry. This information will be exposed for public view. Column entry is optional. Briefly specify instructions about how the specimen(s) needs tobe handled. Acceptable format: free-text entry. This information will be exposed for public view.Additional Test / Assay Information FieldsField NameComparable test/assayDescription Column is optional but strongly recommended. Specify all comparable test/assays. Comparable test/assays may be defined as LDTs, FDAapproved kits, etc. Acceptable format: free-text entry. Confidential: This information will not be exposed for publicview.12
Fields ReferenceField NameKitKit ManufacturerDescription Column entry is required. Indicate, via the dropdown options, if the test/assay is in kitform. Acceptable format: Y/N. Confidential: This information will not be exposed to public view. Column is required with previous column entry = "Yes." Indicate the kit manufacturer's name and the name of thetest/assay kit itself. Acceptable format: free-text entry. Confidential: This information will not be exposed to public view.13
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Palmetto GBA Test Identifier (PTI) Application Guide

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