Are multiplex assays approvable?

Bioanalysis

Volumn 3, Issue 16, 2011, Pages 1791-1794

  Thomae, Mya ^a  

^a Myraqa Inc   (United States)

Author keywords

clinical diagnostics; intended use; multiplex assay; US FDA approved; US FDA cleared

Indexed keywords

ASSAY; DIAGNOSTIC TEST; EDITORIAL; FOOD AND DRUG ADMINISTRATION; LABORATORY TEST; MULTIPLEX ASSAY; RECURRENCE RISK; RISK FACTOR; SCREENING TEST; UNITED STATES;

BIOLOGICAL MARKERS; CLINICAL LABORATORY TECHNIQUES; FEMALE; HUMANS; MALE;

EID: 80052439459     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.174     Document Type: Editorial

References (4)

1. Class II special controls guidance document: instrumentation for clinical multiplex test systems - guidance for industry and FDA staff. www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ ucm077819.htm
2. Draft guidance for industry, clinical laboratories, and FDA staff: in vitro diagnostic multivariate index assays. www.fda.gov/downloads/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm071455.pdf
3. FDA shelves IVDMIA final guidelines in order to focus on overall LDT regulation. Genome Web. www.genomeweb.com/dxpgx/fda-shelves-ivdmia-final- guidelines-order-focus-overall-ldt-regulation
4. Draft Guidance for Industry and FDA staff - commercially distributed in vitro diagnostic products labeled for research use only or investigational use only: frequently asked questions. www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm253307.htm