HQ 955454: Request for tariff classification of the "Gluten HomeTest Kit"

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                          April 5, 1996

                            HQ  955454


CLA-2   RR:TC:FC   955454 ASM 

CATEGORY:  Classification

TARIFF NO.:  3002.10.0090

Mr. John Cantwell
A.N. Deringer, Inc.
P.O. Box 43
Rte. 37
Massena, NY  13662

     RE:  Request for tariff classification of the "Gluten Home
Test Kit" 

Dear Mr. Cantwell:

     This letter is in response to your request for a tariff
classification of  a product  known as the "Gluten Home Test Kit" 
which has been imported into the United States. 

FACTS:

     The product  under consideration is an in-vitro, diagnostic
kit, namely:  the "Gluten Home Test Kit."  According to the
descriptive literature supplied, this kit is used to determine
the presence of gluten, which is a mixture of many proteins found
in wheat, and also, to some extent, in other cereal grains.  The
need for measuring gluten in foods becomes relevant for
individuals afflicted with "Coeliac" disease (the inability to
digest gluten).  Each kit determines the presence of gluten in
foods, based on the principle of a monoclonal antibody-based
enzyme immunoassay.   The product is a diagnostic kit which is
meant to be sold at a retail level, not intended to be
administered to a patient.  

ISSUE:

     Whether the "Gluten Home Test Kit" is properly classified as
an "Antisera and other blood fractions" under subheading
3002.10.0050, Harmonized Tariff Schedule of the United States
Annotated (HTSUSA),  based on the presence of a monoclonal
antibody-based enzyme immunoassay.

                              - 2 -

LAW AND ANALYSIS:

     Classification of merchandise under the HTSUSA, is made in
accordance with the General Rules of Interpretation (GRI's).  The
systematic detail of the harmonized system is such that virtually
all goods are classified by application of GRI 1, that is,
according to the terms of the headings of the tariff schedule and
any relative section or chapter notes.  In the event that the
goods cannot be classified solely on the basis of GRI 1, and if
the headings and legal notes do not otherwise require, the
remaining GRI's may then be applied.  The Explanatory Notes to
the Harmonized Commodity Description and Coding System (EN's),
which represent the official interpretation of the tariff at the
international level, facilitate classification under the HTSUSA
by offering guidance in understanding the scope of the headings
and GRI's.

     The main component of the product is the monoclonal
antibody.  Antibodies are immunoglobulins which are stimulated by
an antigenic response.  Monoclonal antibodies are highly specific
antibodies produced by hybridoma cells.  The kit is composed of
gluten standards for quantitative evaluation, an extractant
solution, a stopping solution, washing buffer, diluent buffer, 
and the anticlonal antibodies (immobilized on microwell strips). 
Additionally, the extractant solution contains additives which
serve as binders for the ployphenols, which are known to
interfere in the extraction of gliadins.

     Although the kit's main component is the monoclonal
antibody, the kit contains other elements which make it a
"composite" diagnostic reagent.  Nevertheless, the product is not
classifiable as a composite diagnostic reagent  under heading
3006, HTSUSA, because it is intended as a self-diagnostic kit
sold at the retail level and is not necessarily intended to be
administered to a patient. 

     GRI 1 requires that classification be determined first
according to the terms of the headings of the tariff schedule and
any relative section or chapter notes and, unless otherwise
required, accordiang to the remaining GRI's taken in order. 
Inasmuch as the kit contains items that may be classified under
more than one heading (i.e., monoclonal antibodies, gliadin
antigen reference standard, starch reference standards, and
binders for polyphenols in the extraction solution), it is not
classifiable pursuant to GRI 1.  GRI 2 is inapplicable because it
governs the classification of incomplete or unfinished articles
or mixtures, neither of which apply to this product. 
Classification under GRI 3(a) is not applicable because there is
no single heading which provides the most specific description
for the kit.
                              - 3 -


     GRI 3(b) is applicable when goods are, prima facie,
classifiable under two or more headings, and have been put up in
sets for retail sale.  GRI 3(b) states that the goods "shall be
classified as if they consisted of the material or component
which gives them their essential character."  In this case, the
kit constitutes "goods put up in sets for retail sale."  The main
component of the product, which provides for the essential
character of the kit, is the monoclonal antibody.  The
classification, therefore, is governed by GRI 3(b), with the
essential character of each kit imparted by the monoclonal
antibody component. 

     It is our position that this set or kit, having the
monoclonal antibodies as its essential character is properly
classifiable in subheading 3002.10.0090, HTSUSA, which provides
for "Antisera and other blood fractions and immunological
products."  Furthermore, the 1996 HTSUSA now specifically
provides for monoclonal antibodies in Chapter 30, Note 2, which
states as follows:

          For the purposes of heading 3002, the
          expression "modified immunological products:
          applies only to monoclonal antibodies (MABs),
          antibody fragments, antibody conjugates and
          antibody fragment conjugates.                 
                               . 

     In addition, the ENs to heading 3002 states that the heading
covers "Antisera... used for diagnostic purposes, including in
vitro tests.  Specific immunoglobulins are purified preparations
of antisera."  Clearly this heading covers the subject kit
because, as previously mentioned, the kit is intended to be self-administered for a diagnostic purpose and contains as its primary
component the monoclonal antibody which is an immunoglobulin that
will be stimulated by an antigenic response. 

HOLDING:

     The product identified under the name, "Gluten Home Test
Kit," is properly classifiable within subheading 3002.10.0090,
HTSUSA, which  provides for  "Human blood; animal blood prepared
for therapeutic, prophylactic or diagnostic uses; anitsera and
other blood fractions and modified immunological products,
whether or not obtained by means of
biotechnological processes; vaccines, toxins, cultures of
micro-organisms (excluding
yeasts) and similar products: Antisera and other blood fractions
and modified immunological products, whether or not obtained by
means of biotechnological processes; Other."  Merchandise
classified under the foregoing subheading is duty free in column
one.
                              - 4 -


     Although your original request referenced a second product,
"Gluten Lab Test Kit," we have been unable to provide a ruling on
this item because there was no record of a sample being received
or tested by the U.S. Customs Service.

     This merchandise may be subject to the regulations of the
Food and Drug Administration. You may contact them at 5600
Fishers Lane, Rockville, MD 20857, telephone number (301) 443-
3170.
                    
                              Sincerely, 




                              John Durant, Director
                              Tariff Classification
                              Appeals Division