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M-I-03-8: IDEXX Laboratories Inc. New Snap Beta-lactam Test

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HHS:PHS:FDA:CFSAN:OC:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-03-8

May 30, 2003

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: IDEXX Laboratories Inc. New Snap Beta-lactam Test

The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has evaluated data supporting the use of the IDEXX Laboratories Inc. New Snap Beta-lactam Test for raw, commingled bovine milk.

The FDA evaluation of the data, presented by IDEXX Laboratories, Inc., indicates that the performance of the test meets the standards established to determine the acceptance of a test for use in raw, commingled bovine milk. The acceptance of the test for raw, commingled bovine milk represents a claim for amoxicillin, ampicillin, cerftiofur, cephapirin, and penicillin G. These data have been evaluated in accordance with the standards established for the acceptance of screening tests for monitoring raw, commingled milk in accordance with the provisions of Appendix "N" of the Grade "A" Pasteurized Milk Ordinance.

The NCIMS Executive Board at the 2003 NCIMS Conference in Seattle, WA accepted the use of this test when used as labeled. Following is the letter of acceptance from FDA's CVM.

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 will also be available on the FDA Web site at http://www.cfsan.fda.gov at a later date and should be widely distributed to State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian Professional Organizations, representatives of the dairy industry and other interested parties.

Attachment: (DRAFT) New SNAP Beta-lactam Test Kit (penicillin G, amoxicillin, ampicillin, ceftiofur, and cephapirin) Validated for raw, commingled bovine milk
 

/s/

CAPT Robert F. Hennes, RS, MPH
Chief, Milk Safety Branch
 

Memorandum

Date: April 9, 2003

From: Philip James Kijak, Ph.D.

Subject: IDEXX Laboratories Inc. New SNAP Beta-Lactam Test

To: Robert F. Hennes, Milk Safety Team

IDEXX Laboratories, Inc. has provided data supporting the use of the IDEXX Laboratories, Inc. New SNAP Beta-Lactam Test for amoxicillin, ampicillin, ceftiofur, cephapirin, and penicillin G in bovine milk. These data have been evaluated in accordance with the standards established for the acceptance of screening tests for raw, commingled bovine milk to monitor milk in accordance to the provisions of appendix N of the Pasteurized Milk Ordnance. (PMO)

The 90/95 percent detection levels and drug concentration responses for the six beta-lactam drugs are as follows:

90/95 Percent Detection Levels (ppb)

Amoxicillin 7.3
Ampicillin 5.8
Ceftiofur 5.4
Cephapirin 11.7
Penicillin G 3.0

Drug Concentration Response (Displayed as Percent Positive) Concentration

ppb (part
per billion)
AmoxicillinAmpicillinCeftiofur CephapirinPenicillin G
Tolerance or
Safe Level
10 ppb10 ppb50 ppb220 ppb5 ppb
1    7
200 037
3    93
42037 0100
5    100
670100   
8100100   
1010010087  
12   100 
20  100100 
30  100  
40  100  
50  100  

2 Parent Drug

It is important to note that this is a new test and as such does not have an approval for visual reading. IDEXX Laboratories, Inc. has agreed cease production of the current SNAP beta-lactam test, which can be read visually once the new test is released. Upon phase out of the current SNAP Beta-Lactam Test, no IDEXX Laboratories, Inc. products will be approved for visual reading.

As a new test, the printout from the reader used with the test must meet the current requirements printing results. Currently, only the IDEXX SNAPshot reader meets these requirements and can be used as a reader with the New SNAP Beta-Lactam Test. The use of the older SNAP Image Reader as currently configured will not be allowed. IDEXX Laboratories, Inc. has the option of providing a software update for the SNAP Image Reader to bring the printout into compliance with current labeling requirements. Otherwise, the use of the New SNAP Beta-Lactam Test will be limited to being read with only the SNAPshot Reader.

RECOMMENDATION

Our evaluation of the data presented by IDEXX Laboratories, Inc. indicates that the performance of this test meets the standards established for acceptance of screening tests for monitoring raw commingled milk in accordance with the provisions of Appendix N of the PMO when used with the IDEXX Laboratories, Inc. SNAPshot reader. We recommend that the appropriate announcement be issued to the milk industry advising of the Agency's concurrence with the use of the test as labeled. We also recommend that revised M-a-85 and M-I-96-10 be issued concurrently with this announcement.
 

/s/

Philip James Kijak, Ph.D.
Analytical Methods Team Leader
Division of Residue Chemistry
CVM Office of Research
 

Linda D. Youngman, Ph.D., Acting Director, CVM Office of Research:

Concur ____x___ Do not Concur _______

Attachment

cc:
LJ Maturin HFH-450

Page 2 - Robert F. Hennes - Milk Safety Team


Attachment: (DRAFT) New SNAP Beta-lactam Test Kit (penicillin G, amoxicillin, ampicillin, ceftiofur, and cephapirin) Validated for raw, commingled bovine milk (available in PDF)