Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

dPOD CP f 95% CI g ERP Use Only OMB Meeting 4-11-2019 Pre-read Materials dPOD CP f 95% CI g

398

dPOD CP f 95% CI g

CFU a / Test Area N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 400 & 4000 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 42 & 530 20 5 0.25 0.11, 0.47 5 0.25 0.11, 0.47 0.00 -0.26, 0.26 Test Area N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 360 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 35 20 15 0.75 0.53, 0.89 15 0.75 0.53, 0.89 0.00 -0.26, 0.26 Test Area N b Presumptive Confirmed x c POD CP d 95% CI X POD CC e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 590 & 3600 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 590 & 3600 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 AOAC Research Institute - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 64 & 540 20 15 0.75 0.53, 0.89 15 0.75 0.53, 0.89 0.00 -0.26, 0.26 64 &540 20 15 0.75 0.53, 0.89 15 0.75 0.53, 0.89 0.00 -0.26, 0.26 360 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 CFU a / - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 35 20 15 0.75 0.53, 0.89 15 0.75 0.53, 0.89 0.00 -0.26, 0.26 400 & 4000 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43 CFU a / - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 42 & 530 20 5 0.25 0.11, 0.47 5 0.25 0.11, 0.47 0.00 -0.26, 0.26

OMA ERP - June 2016

OMAMAN-29 D/ PTM Validation Report 111501

Expert Review Panel Use Only

Table 15: 3M ™ MDA 2 - Listeria Assay, Presumptive vs. Confirmed – POD Results (INDEPENDENT STUDY) Matrix Strain Analysis Time Point Stainless Steel (225 mL) L. monocytogenes ATCC 19118 & Enterococcus faecium ATCC 19434 24 Hours 26 Hours Matrix Strain Analysis Time Point Sealed Concrete (100 mL) L. monocytogenes ATCC 19117 24 Hours 26 Hours Matrix Strain Analysis Time Point Plastic (10 mL) L. monocytogenes ATCC 51782 & 24 Hours

26 Hours

Enterococcus faecalis

ATCC 29212

= Difference between the candidate method presumptive result and candidate method confirmed result POD values

a CFU/Test Area = Results of the CFU/Test area were determined by plating the inoculum for each matrix in triplicate b N = Number of test portions c x = Number of positive test portions d POD CP = Candidate method presumptive positive outcomes divided by the total number of trials e POD CC = Candidate method confirmed positive outcomes divided by the total number of trials f dPOD CP

g 95% CI = If the confidence interval of a dPOD does not contain zero, then the statistically significant at the 5% level All matrixes tested in Table 13 used Demi Fraser (with FAC) brand Y.

04/05/2019