March 10, 2004
|TO:||All Regional Food and Drug Directors
Attn: Regional Milk Specialists
|FROM:||Milk Safety Branch (HFS-626)|
|SUBJECT:||DSM Food Specialties' Delvo®Scan Reader For The Delvotest® P 5 PACK|
The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has evaluated data supporting the use of DSM Food Specialties' Delvo®Scan Reader as an instrument reader for the Delvotest® P 5 PACK.
The Delvo®Scan Reader has been validated as a reader when testing raw, commingled bovine milk and pasteurized bovine white milk (0%-3.5% fat) for amoxicillin, ampicillin, cephapirin and penicillin-G.
The data have been evaluated in accordance with the standards established for the acceptance of screening tests for raw, commingled bovine milk used for testing in accordance to the provisions of Appendix N of the Grade "A" Pasteurized Milk Ordinance (PMO).
The data submitted demonstrated that the Delvo®Scan Reader provides results equivalent to the results obtained from visual reading. No changes to the 90/95 concentrations or sensitivity data currently listed on the label and in M-a-85 are required. It is important to note that as no changes were made to the 90/95 concentrations, this is not considered a new test, and the visual reading option is still available. The printout from the reader used with the test must meet the current requirements for printing results.
CVM's evaluation of the data presented by DSM Food Specialties indicates that the performance of the Delvotest® P 5 PACK when used with the Delvo®Scan Reader meets the standards established for acceptance of screening tests for monitoring raw, commingled bovine milk and pasteurized bovine white milk in accordance with the provisions of Appendix N of the PMO.
NOTE: The Delvo®Scan Reader has not been evaluated for use to test bovine cream or chocolate milk. For these products, the Delvotest® P 5 Pack must be read visually.
Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry, State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian Professional Organizations and other interested parties and also will be available on the FDA Web site at http://www.cfsan.fda.gov (Updated Web Address) at a later date.
If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.
CAPT Robert F. Hennes, RS, MPH, Chief
Milk Safety Branch