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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection

Wed, 05/18/2011 - 6:31am
U.S. Food & Drug Administration

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact Beena Puri, Ph.D., Division of Microbiology Devices at 301-796-6202 or by email: beena.puri@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 Microbiology Devices

Preface

  1. Clinical and Laboratory Standards Institute (CLSI). Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition. CLSI document H18-A3 (ISBN 1-56238-555-0). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  2. Clinical Laboratory Standards Institute (CLSI). Specifications for Immunological Testing for Infectious Diseases; Approved Guideline – Second Edition. CLSI document I/LA18-A2 (ISBN 1-56238-445-7) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001.
  3. Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Second Edition. CLSI document EP5-A2 (ISBN 1-56238-000-0). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  4. Clinical and Laboratory Standards Institute (CLSI). Molecular Diagnostic Methods for Infectious Disease; Approved Guideline. CLSI document MM3-A2 [ISBN 1-56238-596-8] Clinical and Laboratory Standards Institute, Wayne, Pennsylvania 19087-1898 USA , 2006.
  5. Clinical and Laboratory Standards Institute (CLSI). Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; CLSI document GP10-A Approved Guideline: Clinical and Laboratory Standards Institute; Wayne, Pennsylvania 19087-1898 USA, 1995).
  6. Clinical Laboratory Standards Institute (CLSI). Protocols for Determination of Limits of Detection and limits of Quantitation; Approved guideline – CLSI document EP17-A (ISBN 1-56238-551-8) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
  7. Clinical Laboratory Standards Institute (CLSI). Interference Testing In Clinical Chemistry Approved Guidelines – Second Edition. CLSI document EP7-A2 (ISBN 1-56238-000-0) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
  8. Clinical Laboratory Standards Institute (CLSI). User Verification Of Performance For Precision And Trueness Approved Guidelines – Second Edition. CLSI document EP15-A2 (ISBN 1-56238-000-0) CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
  9. Clinical and Laboratory Standards Institute (CLSI). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline. CLSI document EP12-A (ISBN 1-56238-468-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.

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