ELECTRONIC SOMATIC CELL COUNT
Foss 250/300/360/400
[Unless otherwise stated all tolerances are ±5%]
FORM FDA 2400h-1 (3/01)
Page 1 of 2
LABORATORY
LOCATION
DATE
LAB #
X = DEVIATION
U = UNDETERMINED
O = NOT USED
NA = NOT APPLICABLE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
MILK LABORATORY EVALUATION FORM
EF
1. Laboratory Requirements (see CP, item 33 & 34) .....................
a. Unpreserved samples may be run up to 72 hours after initial
collection
b. Samples may be run up to 7 days after initial collection if
preserved with 0.02% 2-bromo-2-nitropropane-1, 3-diol
(Bronopol™) or 0.05% potassium dichromate (K2Cr2O7) ...........
c. Comparative test with DMSCC .................................................
1. Performed by each analyst performing ESCC test ...............
2. Test 4 samples (100K - 200K; 300K - 500K; 600K - 800K
and 900K - 1.2M) in triplicate for both DMSCC (three
separate smears each) and ESCC (three separate sub-
samples each, do not read same sample three times) .........
3. Results must be shown to be acceptable prior to official
testing by analyst performing comparison, i.e. analyst is
not certified until found acceptable (co-requisite for
certification) .......................................................................
4. Copy of comparison and results in QC record (or easily
accessible file in laboratory) ...............................................
d. Analysts certified for DMSCC ..................................................
APPARATUS
2. See Cultural Procedures, items 1 - 5 .........................................
3. Automated Electronic Somatic Cell Counters ............................
a. Fossomatic 250 _______ .......................................................
b. Fossomatic 300 _______ .......................................................
c. Fossomatic 360 _______ .......................................................
d. Fossomatic 400 _______ .......................................................
4. Water Bath ....