Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

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

390

MPN a / Test Portion N b 3M MDA2 USDA/FSIS MLG dPOD C f 95% CI g x c POD C d 95% CI X POD R e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

0.31 (0.14, 0.57) 20 4 0.20 0.08, 0.42 5 0.25 0.11, 0.47 -0.05 -0.30, 0.21 0.5 5 3 0.60 0.23, 0.88 1 0.20 0.04, 0.62 0.40 -0.16, 0.73 dPOD C f 95% CI g x c POD C d 95% CI X POD R e 95% CI

0.5 5 2 0.40 0.12, 0.77 4 0.80 0.38, 0.96 -0.40 -0.73, 0.16 MPN a / Test Portion N b 3M MDA2 FDA-BAM - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 dPOD C f 95% CI g

1.7 5 3 0.60 0.23, 0.88 4 0.80 0.38, 0.96 -0.20 -0.60, 0.31 MPN a / Test Portion N b 3M MDA2 ISO 11290-1 x c POD C d 95% CI X POD R e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 dPOD C f 95% CI g

dPOD C f 95% CI g

dPOD C f 95% CI g

0.26 (0.10, 0.47) 20 6 0.30 0.15, 0.52 3 0.15 0.05, 0.36 0.15 -0.11, 0.39

0.26 (0.10, 0.47) 20 6 0.30 0.15, 0.52 9 0.45 0.26, 0.66 -0.15 -0.41, 0.14 x c POD C d 95% CI X POD R e 95% CI 1.7 5 3 0.60 0.23, 0.88 4 0.80 0.38, 0.96 -0.20 -0.60, 0.31 MPN a / Test Portion N b 3M MDA2 FDA-BAM - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43 0.27 (0.10, 0.49) 20 10 0.50 0.30, 0.70 8 0.40 0.22, 0.61 0.10 -0.19, 0.37 1.7 5 5 1.00 0.57, 1.00 4 0.80 0.38, 0.96 0.20 -0.26, 0.62 AOAC Research Institute 0.27 (0.10, 0.49) 20 10 0.50 0.30, 0.70 7 0.35 0.18, 0.57 0.15 -0.15, 0.41 1.7 5 5 1.00 0.57, 1.00 4 0.80 0.38, 0.96 0.20 -0.26, 0.62 MPN a / Test Portion N b 3M MDA2 ISO 11290-1 x c POD C d 95% CI X POD R e 95% CI - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

MPN a / Test Portion N b 3M MDA2 USDA/FSIS MLG - 5 0 0.00 0.00, 0.43 0 0.00 0.00, 0.43 0.00 -0.43, 0.43

0.3 (0.10, 0.5) 20 4 0.20 0.08, 0.42 5 0.25 0.11, 0.47 -0.05 -0.30, 0.21 x c POD C d 95% CI X POD R e 95% CI

OMA ERP - June 2016

OMAMAN-29 D/ PTM Validation Report 111501

Expert Review Panel Use Only

Table 8: 3M ™ MDA 2 - Listeria Assay, Candidate vs. Reference – POD Results (INTERNAL STUDY) Matrix Strain Analysis Time Point Raw Chicken Leg Pieces h (25 g) L. ivanovii Ad 1291 28 Hours Matrix Strain Analysis Time Point Raw Chicken Fillet i (25 g) L. ivanovii Ad 1291 28Hours Matrix Strain Analysis Time Point Bagged Raw Spinach h (25 g) L. seeligeri Ad 1754 24 Hours Matrix Strain Analysis Time Point Bagged Raw Spinach h (25 g) L. seeligeri Ad 1754 24 Hours

24

24

Analysis Time

Analysis Time

Point

Point

Hours

Hours

Matrix Strain

Matrix Strain

L. innocua Ad 1674

L. innocua Ad 1674

Cold Smoked Salmon h (25 g)

Cold Smoked Salmon h (25 g)

04/05/2019