Microsoft Word - Draft OMB Meeting Agenda-April 11 2019
OMAMAN-29 D/ PTM Validation Report 111501 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 Lot #: 012715
Expiration Date Lot #: 081914
Expiration Date Lot #: 050114
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 ATCC 29212)
Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)
Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)
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
7/10
7/10
Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)
Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)
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 ATCC 29212)
Uninoculated Target Organism ( Enterococcus faecalis ATCC 29212)
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
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