HHS:PHS:FDA:CFSAN:OFP:DCP:MSB
 
 5100 Paint Branch Parkway
            College Park, MD 20740-3835
 
                   M-I-02-3
 
               January 31, 2002
 
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	Idexx Snapshot Reader
 
 
 
IDEXX Laboratories, Inc. has developed a new reader, called the Snapshot Reader,
for use with the Snap BL test kit.  This is a replacement for the current Snap
Image Reader, which is no longer being manufactured.
 
The new Snapshot reader has been validated by IDEXX Laboratories, Inc. to
demonstrate that its performance is equivalent to the current image reader.  The
study protocol was designed with oversight by the Food and Drug Administration
(FDA), Center for Veterinary Medicine's Office of Research (CVM OR).  In the
study, penicillin G was added to milk to give concentrations of one (1), four
(4), ten (10), and 100 ppb.  Fifteen (15) Snap BL tests were done at each
concentration and fifteen (15) tests were done on control milk.  Each test was
measured using five (5) Snapshot Readers and five (5) Snap Image Readers.
 
The performance of the Snapshot Reader was equivalent to that of the Snap Image
Reader. No statistical difference was observed in the performance of the two (2)
readers when measuring the ratios of Snap BL test kit devices exposed to control
milk or milk fortified with one (1), four (4), or ten (10) ppb penicillin G.
However, the Snapshot Reader gave slightly lower ratios for the milk fortified
at 100 ppb.  The slight deviation of the performance of the two (2) readers at
100 ppb does not affect the ability of the snapshot reader to distinguish
between positive and negative samples.  As this difference will not cause
erroneous results, it was judged not to be significant by FDA.
 
The reader was evaluated at FDA, Center for Food Safety and Applied Nutrition's
Laboratory Quality Assurance Branch (CFSAN LQAB), and the performance was judged
to be acceptable.  Both CVM OR and CFSAN LQAB reviewed the manual for the
Snapshot Reader and found it acceptable. The printout of the new Snapshot Reader
meets the National Conference on Interstate Milk Shipment's (NCIMS) guidelines.
IDEXX Laboratories, Inc. has demonstrated that the Snapshot Reader is an
acceptable substitute for the Snap Image Reader.  Based upon our review of the
Snapshot Reader, FDA recommends that the Snapshot Reader can be used in place of
the Snap Image Reader for use with the Snap BL test kit in regulatory testing.
 
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Milk 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
representatives of the dairy industry and other interested parties.
 
 
 
 
 
      Robert F. Hennes, RS, MPH
      Chief, Milk Safety Branch
 
 
 
 
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M-I-02-3	4	January 31, 2002