ERP Micro December 2019

METHOD AUTHORS ORIGINAL VALIDATION: Stephanie Thatcher, Mike Powers, E. Jenkyn Powell, and Haleigh Millward MODIFCATION MAY 2016: Ron Johnson, Hari Prakash Dwivedi, Patrice Chablain, and Louisiane Giovannetti MODIFICATION JANUARY 2017: Ron Johnson and John Mills MODIFICATION DECEMBER 2018: Ronald Johnson, John Mills, Vikrant Dutta, Nikki Taylor, Deborah Briese

ORIGINAL SUBMITTING COMPANY Idaho Technology 390 Wakara Way Salt Lake City, UT 84108 USA

CURRENT COMPANY bioMérieux 595 Anglum Road Hazelwood, MO 63042 USA

KIT NAME(S) GENE-UP TM Listeria species 2 (LIS 2) Formerly known as GENE-UP TM Listeria species Detection Kit

CATALOG NUMBERS 423 106

INDEPENDENT LABORATORY Silliker, Inc. Food Science Center 160 Armory Drive South Holland, IL 60473 USA Marshfield Food Safety Marshfield Clinic 1000 N. Oak Ave. Marshfield, WI 54440 USA

MODIFICATION May 2016 Q Laboratories, Inc. 1400 Harrison Ave Cincinnati, OH 45214 USA

AOAC EXPERTS AND PEER REVIEWERS Thomas Hammack 1 , Joseph Odmeru 2 , Michael Brodsky 3 , Yi Chen 4, 5 1 US Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA 2 University of Guelph, Guelph, Ontario, Canada 3 Brodsky Consultants, Thornhill, ON, Canada 4 US Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA 5 Modifications: May 2016, October 2017, December 2018 REFERENCE METHODS United States Food and Drug Administration, FDA Bacteriological Analytical Manual http://www.cfsan.fda.gov/~ebam/bam-10.html (2) United States Department of Agriculture Microbiological Laboratory Guidelines 8.09: Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, Egg Products, and Environmental Sponges. May 1 st , 2013. (Accessed November 2015) http://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9- 4e6c-92fc-fdc290dbfa92/MLG-8.pdf?MOD=AJPERES (5) AOAC Official Method 993.12 Listeria monocytogenes in Milk and Dairy Products: Selective Enrichment and Isolation Method, First Action 1993, Final Action 1996 (Accessed November 2015). (6)

APPLICABILITY OF METHOD Target organism – Listeria species: Listeria innocua, Listeria ivanovii, Listeria monocytogenes, Listeria seeligeri, and Listeria welshimeri Matrices – (USDA/FSIS MLG 8.09) – deli ham (25 g, 125 g), deli turkey (25 g), beef hot dogs (25 g), breaded chicken nuggets (25 g) (FDA BAM Ch 10) – fresh bagged spinach (25 g), fresh bagged lettuce (25 g), cooked shrimp (25 g), smoked salmon (25 g, 125 g), stainless steel (4 x 4 in sponge), whole liquid egg (100 g), whey powder (375 g) (AOAC OMA 993.12) – vanilla ice cream (25 g), Mexican soft cheese (25 g) Modification December 2018: Deli ham (125 g) Performance claims - GENE-UP TM Listeria species assay is equivalent to the reference methods for a Variety of Foods.

ORIGINAL CERTIFICATION DATE January 22, 2009 METHOD MODIFICATION RECORD 1. 2014 2. June 18, 2015 3. May 2016 4. January 2017 5. October 2017 Level 2 6. December 2017 Level 2 7. December 2018 Level 2

CERTIFICATION RENEWAL RECORD Renewed annually through December 2019

SUMMARY OF MODIFICATION 1.

Company name change from Idaho Tech to BioFire Diagnostics 2. Manufacturing location change from BioFire Diagnostics to BioFire Defense, LLC 3. Matrix Extension and addition of GENE-UP format and assignment of new AOAC PTM number 051603 4. Matrix Extension: liquid whole egg, whey powder 5. GENE-UP® software version 2.0 evaluation 6. Editorial updates to insert 7. Modifications include the following: (1) Manufacturing location change from Salt Lake City, Utah to Grenoble bioMérieux facility (2) a change from multi dose format to a unit dose format (3) Software updated to version 3 (4) PTM number change from 051603 to 121803. Under this AOAC® Performance Tested SM License Number, 121803 this method is distributed as: NONE

Under this AOAC® Performance Tested SM License Number, 121803 this method is distributed by: NONE