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Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System

Wed, 03/23/2011 - 8:30am
U.S. Food & Drug Administration

For questions regarding this document contact Donna Roscoe at 301-796-6183 (Donna.Roscoe@fda.hhs.gov), or Marina Kondratovich at 301-796-6036 (Marina.Kondratovich@fda.hhs.gov).

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U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of In Vitro Diagnostic Device Evaluation and Safety

Division of Immunology and Hematology Devices

Preface

  1. ACOG Practice Bulletin No. 83: Management of Adnexal Masses. Obstetrics & Gynecology. 110(1):201-214, July 2007.
  2. Kondratovich M., Yousef WA. Evaluation of accuracy and optimal cutoff of diagnostic devices in the same study. Joint Statistical Meeting. 2005. ASA Section on Statistics in Epidemiology; p.2547-2551.
  3. Gostout BS, Brewer MA. Guidelines for Referral of the Patient with an Adnexal Mass. 2006. Clinical Obstetrics and Gynecology 49(3): 448-459.

1 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm073779.pdf

2 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm073779.pdf

3 Biggerstaff, B.J. Comparing diagnostic tests: a simple graphic using likelihood ratios. Statistics in Medicine 2000, 19: 649-663.

4 PPV depends on a positive likelihood ratio (PLR) and prevalence of malignancy, and NPV depends on negative likelihood ratio (NLR) and prevalence. For a comparison of two tests within the same population, comparison of PPV and NPV is equivalent to comparison of PLR and NLR.

    

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