OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

Attachment 2

AOAC RESEARCH INSTITUTE AOAC OFFICIAL METHODS OF ANALYSIS (OMA)

OMAMAN-20: R-Biopharm, Qualitative Detection of Gluten on Surfaces and In Processed and Non- Processed Products by R5 Immuno-Chromatographic Dip Stick Study Director: Dr. Markus Lacorn & Thomas Weiss, R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany TECHNICAL EVALUATION CRITERIA Is the test kit method scientifically and technically sound? ER 1 yes ER 2 yes ER 3 yes ER 4 yes ER 5 yes ER 6 yes ER 7 yes ER 8 No Have sufficient controls been used, including those required to calculate the rate of false‐positive and false‐negative results where appropriate? ER 1 Yes ER 2 No ER 3 NA ER 4 Yes ER 5 Yes ER 6 Yes ER 7 Yes ER 8 Yes Is sufficient information included for system suitability determination and product performance or acceptance testing? ER 1 Yes ER 2 No ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes ER 7 Yes ER 8 No Are the conclusions statements valid based upon data presented? ER 1 Yes ER 2 No ER 3 No ER 4 Yes ER 5 Yes ER 6 Yes ER 7 Yes ER 8 No Page 1 of 13

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