Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

OMB Meeting 4-11-2019 Pre-read Materials

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Table 16: Lot-to-Lot/Stability Study Results Expiration Date

Expiration Date Lot #: 081914

Expiration Date Lot #: 050114

Lot #: 012715

Sample #

Result

Sample #

Result

Sample #

Result

Listeria monocytogenes ATCC 2 7644

Low Level

6/10

Low Level

6/10

Low Level

6/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

0/5

0/5

0/5

1 - All samples were analyzed from a common lysate 2 ATCC- American Type Culture Collection

Table 17: Robustness Results Robustness 1

Robustness 1 13 Minute Lysis 22 µL 2 , 18 µL 3

13 Minute Lysis 18 µL 2 , 18 µL 3

18 µL 2 , 22 µL 3

22 µL 2 , 22 µL 3

Sample #

Sample #

Listeria monocytogenes ATCC 4 7644

Low Level

6/10

6/10

Low Level

6/10

6/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

0/5

0/5

0/5

0/5

Robustness 1 17 Minute Lysis 18 µL 2 , 18 µL 3 AOAC Research Institute Expert Review Panel Use Only Robustness 1 17 Minute Lysis 22 µL 2 , 18 µL 3 18 µL 2 , 22 µL 3 Sample # 22 µL 2 , 22 µL 3 Listeria monocytogenes ATCC 4 7644

Sample #

Low Level

6/10

6/10

Low Level

6/10

6/10

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

Uninoculated Target Organism ( Enterococcus faecalis ATCC29212)

0/5

0/5

0/5

0/5

1 - All samples were analyzed from a common lysate 2 -Volume of enrichment to lysis 3 -Volume of lysis to assay 4 ATCC- American Type Culture Collection

04/05/2019