Total Collaborative Study Protocol_Solus One Salmonella v1 1

modified food starch, calcium stearate, milk, soy) (375 g), cinnamon powder (25 g), paprika powder (25 

g) and whole black peppercorns (25 g). 

( c ) Summary of Validated Performance Claims .— Depending on matrix, performance is equivalent 

to that of the U.S. Food and Drug Administration Bacteriological Analytical Manual  (FDA/BAM) Chapter 

5 (July 2018)  Salmonella  (1) for detection of  Salmonella  spp. from raw salmon (fillet), cheddar cheese 

(shredded), Romaine lettuce (bagged), non‐fat dry milk (NFDM) powder and selected environmental 

surfaces. In addition, performance is equivalent to that of U.S. Department of Agriculture Food Safety 

and Inspection Service Microbiology Laboratory Manual , (MLG) 4.09 (January 2017)  Isolation and 

Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Siluriformes (Fish) Products and 

Carcass and Environmental Sponges  (2) for detection of  Salmonella  spp. from raw beef (trim) and 

pasteurized eggs.

           Method Modification Performance Claims .— Performance is equivalent to that of the U.S. 

Food and Drug Administration Bacteriological Analytical Manual  (FDA/BAM) Chapter 5 (July 2018) 

Salmonella  (1) for detection of  Salmonella  spp. from honey mustard onion seasoning, flavored ranch 

seasoning, cinnamon powder, paprika powder and whole black peppercorns. 

Definitions 

( a )  Probability of Detection.— Probability of Detection (POD) is t he proportion of positive 

analytical outcomes for a qualitative method for a given matrix at a given analyte level or concentration. 

POD is concentration dependent. Several POD measures can be calculated; POD R

 (reference method 

 (confirmed candidate method POD), POD CP

 (candidate method presumptive result POD) and 

POD), POD C

POD CC

 (candidate method confirmation result POD).

Page 4 of 39