BIOMIC V3 Microbiology System, EUCAST, FDA, CLSI, BSAC

EMPOWERING MICROBIOLOGISTS TO PRODUCE QUALITY RESULTS WITH SUPERIOR TECHNOLOGY

FDA CLSI BSAC EUCAST

The US FDA (United States of America Food and Drug Administration) has reviewed and cleared the BIOMIC System by 510(k) for marketing and sales in the USA. It has determined that the BIOMIC System accurately and reproducibly measures zone diameters and determines MICs (minimum inhibitory concentrations) that are substantially equivalent to the MICs determined by the reference CLSI broth dilution method.

Note: The BIOMIC System is currently the only automated zone reader to successfully complete the US FDA 510(k) review process, permitting it to be marketed and sold in the USA.

Giles Scientific recommends that your lab purchase a copy of the most recent CLSI documents.

BIOMIC V3 software includes all relevant information from the CLSI documents listed below. As updated CLSI documents are released, changes are immediately made to the BIOMIC software. These software updates, including additional BIOMIC product features, are provided annually by CD or website download.

Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard. M2, M100.

Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Approved Standard. M31.

Abbreviated Identification of Bacteria and Yeast; Approved Guideline. M35-A.

Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline. M39-A.

Method for Antifungal Disk Diffusion Susceptibility Testing for Yeasts; Approved Guideline. M44-A.

Method for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically- Sixth Edition; Approved Standard. M7.

Method for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Proposed Guideline. M45-P.

Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guideline. M42-A.

Methods for Broth Dilution Susceptibility Testing fo Bacteria Isolated from Aquatic Animals; Approved Guideline. M49-A.

Quality Control for Commercial Microbial Identification Systems; Proposed Guidelines. M50-P.

CLSI, Clinical and Laboratory Standards Institute

940 West Valley Road, Suite 1400

Wayne, PA 19087 USA

Phone: (610) 688-0100

Fax: (610) 688-0700

Email: exoffice@clsi.org

Web: www.clsi.org

BIOMIC V3 software includes all relevant information from the British Society of Antimicrobial Chemotherapy (BSAC) document listed below. As updated BSAC documents are released, changes are immediately made to the BIOMIC software. These software updates, including additional BIOMIC product features, are provided annually by CD or website download.

BSAC Standardized Disc Susceptibility Testing Method - Version 7.1 February 2008

British Society of Antimicrobial Chemotherapy
11 The Wharf
16 Bridge Street
Birmingham B1 2JS
United Kingdom
Phone: +44 (0) 121 633 0410 Fax: +44 (0) 121 643 9497
Email: enquiries@bsac.org.uk
Web: www.bsac.org.uk

BIOMIC V3 software includes all relevant information from the European Committee on Antimicrobial Susceptibility Testing (EUCAST*) document listed below. As updated EUCAST documents are released, changes are immediately made to the BIOMIC software. These software updates, including additional BIOMIC product features, are provided annually by CD or website download.

EUCAST MIC and Zone Diameter Breakpoint Tables (Version 1.0, December 21, 2009)

ESCMID Executive Office
Association House
Freie Strasse 90
4051 Basel
SWITZERLAND
Phone: (41) 61 686 77 99 Fax: (41) 61 686 77 98
Email:info@escmid.org
Web: www.escmid.org