Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

ERP Use Only OMB Meeting 4-11-2019 Pre-read Materials

456

dPOD C f 95% CI g

dPOD C f 95% CI g

dPOD C f 95% CI g

- 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

- 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

- 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

- 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

- 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 8 0.40 0.22, 0.61 -0.10 -0.40, 0.13

- 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 11 0.55 0.34, 0.74 0.20 -0.09, 0.45

42& 540 20 12 0.60 0.39, 0.78 10 0.50 0.30, 0.70 0.10 -0.19, 0.37

400 & 4000 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 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

42 & 530 20 5 0.25 0.11, 0.47 8 0.40 0.22, 0.61 -0.10 -0.40, 0.13

35 20 15 0.75 0.53, 0.89 11 0.55 0.34, 0.74 0.20 -0.09, 0.45

360 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

42& 540 20 12 0.60 0.39, 0.78 10 0.50 0.30, 0.70 0.10 -0.19, 0.37

590 & 3600 5 5 1.00 0.57, 1.00 5 1.00 0.57, 1.00 0.00 -0.43, 0.43

OMA ERP - June 2016

x c POD C d 95% CI X POD R e 95% CI

x c POD C d 95% CI X POD R e 95% CI

x c POD C d 95% CI X POD R e 95% CI

Table 11: 3M ™ MDA 2 Listeriamonocytogenes Assay, Candidate vs. Reference – POD Results (INDEPENDENT STUDY) Matrix Strain Analysis Time Point CFU a / Test Area N b 3M MDA2 Reference Stainless Steel (225 mL) L. monocytogenes ATCC 19118 & Enterococcus faecium ATCC 19434 24 Hours 26 Hours Matrix Strain Analysis Time Point CFU a / Test Area N b 3M MDA2 Reference Sealed Concrete (100 mL) L. monocytogenes ATCC 19117 24 Hours 26 Hours Matrix Strain Analysis Time Point CFU a / Test Area N b 3M MDA2 Reference 24 Hours

OMAMAN-30 D/ PTM Validation Report 081501

AOAC Research Institute

Expert Review Panel Use Only

26 Hours

L. monocytogenes ATCC 51782 &

Enterococcus faecalis

ATCC 29212

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 C = Candidate method confirmed positive outcomes divided by the total number of trials e POD R = Reference method confirmed positive outcomes divided by the total number of trials f dPOD C = Difference between the confirmed candidate method result and reference method confirmed result POD values

Plastic

(10 mL)

g 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level

04/05/2019