In Vitro Diagnostics
In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
News & Events
Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel (PDF - 921KB)Letter to Medical Diagnostic Laboratories, LLC regarding the Zika Virus–Blood–PCR Test (PDF - 40KB)Letter to First Diagnostic Corporation regarding the ATFirst’s One Step Zika Antibody Test (PDF - 691KB)Letter to Texas Children’s Hospital and Houston Methodist Hospital regarding the Zika Direct Test (PDF - 558KB)Letter to MD Biosciences Regarding the Zika Virus RNA by RT-PCR Assay (PDF - 357KB)Letter to SoloPAP concerning the SoloPAP Home HPV&PAP test (PDF - 202KB)Letter to Sure Genomics, Inc. concerning SureDNA Test for Collection of Saliva Samples for DNA Sequencing (PDF - 122KB)Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism (PDF - 161KB)Letter to Genomic Express, Inc. concerning pharmacogenomic tests (PDF - 185KB)Letter to Kailos Genetics, Inc. concerning test to analyze multiples genes (PDF - 176KB)Letter to Harmonyx concerning test for antiplatelets, statins, ADHD, and pain (PDF - 174KB)Pathway Genomics Letter - September 21, 2015 (PDF - 48KB)The FDA-CDC Antimicrobial Resistance Isolate Bank - Letter to 23andMe, Inc. Concerning the 23andMe Saliva Collection Kit and Personal Genome Service
- Letter to Biosense Technologies Private Limited Concerning the uChek Urine Analyzer
Correspondence related to Duke University Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for Chemo-naïve Select Stage IIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genome Predictor of Platinum-Resistance to Guide Therapy Letter to Lumigenix Inc Concerning Direct to Consumer Advertising Letter to American International Biotechnology Services Concerning Direct to Consumer Advertising Letter to Precision Quality DNA Concerning Direct to Consumer Advertising Letter to IDENTIGENE Concerning the Identigene STD Test Letter to Manufacturers of Troponin Assays Listed with the FDA - Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA
Letters to Manufacturers Concerning Genetic Tests - Letter to Manufacturers with HbA1c Assays Listed with the FDA
Letter to Navigenics Concerning the NaviGenics Health Compass (PDF - 114KB)Letter to Illumina, Inc. Concerning the Illumina Infinium HumanHap550 array (PDF - 169KB)Letter to 23andMe, Inc. Concerning the 23andMe Personal Genome Service (PDF - 163KB)Archived OIR News Items - Letter to DNA-Cardiocheck, Inc. Concerning the DNA CardioCheck Test (PDF - 167KB)
- Letter to DNA4Life Concerning the Pharmacogenetic Report (PDF - 164KB)
- Letter to Interleukin Genetics, Inc. Concerning the PerioPredict® Genetic Test (PDF - 211KB)
Information for Health Professionals
Safety Tips for Laboratorians [ARCHIVED]
OIR Regulatory Resources
FDA eSubmitter Overview of IVD Regulation Clinical Laboratory Improvement Amendments (CLIA) Office of In Vitro Diagnostics and Radiological Health Final Guidance Device Advice: Comprehensive Regulatory Assistance In Vitro Diagnostic Device Labeling Requirements Office of In Vitro Diagnostics and Radiological Health Manufacturer Certification Programs Suggested Analytical Testing Protocol for In Vitro Diagnostic Devices Manufactured with Heparin Contaminated With Oversulfated Chondroitin Sulfate - Indications for Use Form (PDF - 1.7MB)
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) - Recent Scientific Publications
Nucleic Acid Based Tests
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