CLA-2-90:OT:RR:NC:N1:105
Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW, Suite 300
Washington, DC 20006
RE: The tariff classification of blood glucose monitoring systems from various countries
Dear Mr. Finkelstein:
In your letter dated June 27, 2025, on behalf of your client, Arkray Factory USA, Inc., you requested a tariff
classification ruling. Descriptive literature was provided for our review.
The first item under consideration is the Assure Platinum Meter (part number 500001), which is a blood
glucose monitoring system designed for use in long-term care and multi-patient settings. It works by using a
small blood sample (0.5 microliter) applied to a test strip inserted into the meter. The meter then analyzes the
blood sample and displays the glucose reading within 7 seconds. The meter measures the electrical current
produced by the enzymatic reaction between the glucose in the blood sample and the reagent on the test
strip. The meter features a backlit LCD display, a test strip ejector, and stores up to 500 test results with time
and date stamps. The system includes the meter and owner’s guide and is produced in the Philippines.
The second item under consideration is the Assure Prism Multi Meter (part number 530001), which is a
blood glucose monitoring system designed for use in professional healthcare settings. It allows healthcare
professionals to quantitatively measure glucose levels in fresh capillary whole blood samples, providing fast
and accurate results. The meter operates substantially similar to the first item by analyzing a small blood
sample applied to a test strip, with results displayed on the meter’s screen within seconds. The system
includes the meter and owner’s guide and is produced in South Korea.
The third item under consideration is the Glucocard Vital Meter Basic (part number 760001), which is a
blood glucose monitoring system that measures the amount of glucose in a blood sample taken from a
fingertip or palm. It uses auto-coding technology, meaning it automatically calibrates when a test strip is
inserted, simplifying the testing process. The meter then detects the glucose level in the blood sample and
displays the result on a large, easy-to-read screen. The system includes the meter and owner’s guide and is
produced in the Philippines.
The fourth item under consideration is the Glucocard Shine Meter Basic (part number 540001), which is a
blood glucose monitoring system that measures blood glucose levels by analyzing the electrical current
generated when a blood sample reacts with a chemical on the test strip. This electrical current is then
converted into a glucose reading displayed on the meter. The system includes the meter, carrying case, and
owner’s guide and is produced in South Korea.
The fifth item under consideration is the Glucocard Expression Meter Basic (part number 570001), which is a
blood glucose monitoring system that works by analyzing a small blood sample applied to a test strip. The
meter uses a chemical reaction within the strip to determine the blood glucose level. After the sample is
applied, the meter counts down and then displays the glucose reading on its screen. The meter also has
optional voice features to assist users with setup and testing. The system includes the meter, carrying case,
and owner’s guide, and is produced in Taiwan.
General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in
part that for legal purposes, classification shall be determined according to the terms of the headings and any
relative section or chapter notes. Goods that are, prima facie, classifiable under two or more headings, are
classifiable in accordance with GRI 3, HTSUS. GRI 3(a) states, in part, that when two or more headings each
refer to a part of the items in a set put up for retail sale, those headings are to be regarded as equally specific,
even if one heading gives a more precise description of the good. The instant goods consist of at least two
different articles that are, prima facie, classifiable in different subheadings. It consists of articles put up
together to carry out a specific activity (i.e., blood glucose testing). Finally, the articles are put up in a
manner suitable for sale directly to users without repacking. Therefore, the goods in question are within the
term “goods put up in sets for retail sale.” GRI 3(b) states, in part, that goods put up in sets for retail sale,
which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component
which gives them their essential character. It is the opinion of this office that the essential character of the
glucose meters when imported with the manual and carrying case is imparted by the glucose meter.
In your letter you suggest the applicable subheading for the glucose meters to be 9027.50.8015, HTSUS,
which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters,
refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or
checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring
or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories
thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Other:
Chemical analysis instruments and apparatus.” We disagree. Each of the glucose monitoring devices use an
electro-chemical process creating a current to provide the readings. There are no optical elements present in
the meters. Therefore, subheading 9027.50, HTSUS, is not applicable.
Accordingly, the applicable subheading for the Assure Platinum Meter (part number 500001), the Assure
Prism Multi Meter (part number 530001), the Glucocard Vital Meter Basic (part number 760001), the
Glucocard Shine Meter Basic (part number 540001), and the Glucocard Expression Meter Basic (part number
570001) will be 9027.89.4530, HTSUS, which provides for “Instruments and apparatus for physical or
chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis
apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface
tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light
(including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus:
Other: Other: Electrical: Chemical analysis instruments and apparatus.” The general rate of duty will be free.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries
will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading
9027.89.4530, HTSUS, listed above.
In your letter, you also requested consideration of a secondary classification for the subject Assure Platinum
Meter, the Assure Prism Multi Meter, the Glucocard Vital Meter Basic, the Glucocard Shine Meter Basic,
and the Glucocard Expression Meter Basic under 9817.00.96, HTSUS, which applies to articles and parts of
articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or
mentally handicapped. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other
physically or mentally handicapped persons as including “any person suffering from a permanent or chronic
physical or mental impairment which substantially limits one or more major life activities, such as caring for
oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.”
We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection
(CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of
U.S. Note 4(a) to Chapter 98 of the HTSUS. In HQ 562869 (dated December 23, 2003), CBP held that a
pump designed for individuals suffering from diabetes or glucose control problems was an article specifically
designed or adapted for the handicapped and is properly classified under 9817.00.96 for secondary
classification purposes. In N292225 (dated December 18, 2017), CBP held that Insulet’s Insulin Delivery
Omnipod was classified under 9817.00.96 for secondary classification purposes.
Additionally, as discussed in Headquarters ruling HQ 964169 (dated June 26, 2001), “people with diabetes
are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood
sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea,
dizziness and fainting. This interferes with working, a major life activity. Therefore, persons with diabetes
suffer from a permanent or chronic physical impairment which substantially limits a major life activity and
therefore, are considered physically handicapped persons under U.S. Note 4(a).” The Assure Platinum Meter,
the Assure Prism Multi Meter, the Glucocard Vital Meter Basic, the Glucocard Shine Meter Basic, and the
Glucocard Expression Meter Basic perform a chemical analysis on a diabetic’s blood sample to determine if
their levels are too high or too low, which is a direct link to the physical impairment.
Accordingly, based on the information provided, it is the opinion of this office that the Assure Platinum
Meter, the Assure Prism Multi Meter, the Glucocard Vital Meter Basic, the Glucocard Shine Meter Basic,
and the Glucocard Expression Meter Basic are specifically designed for use by the handicapped for
secondary classification purposes. In our view, the Assure Platinum Meter, the Assure Prism Multi Meter, the
Glucocard Vital Meter Basic, the Glucocard Shine Meter Basic, and the Glucocard Expression Meter Basic
satisfy the description set forth in Chapter 98, Subchapter XVII, U.S. Note 4(a). Therefore, we agree that
secondary classification 9817.00.96, HTSUS, would apply to the Assure Platinum Meter, the Assure Prism
Multi Meter, the Glucocard Vital Meter Basic, the Glucocard Shine Meter Basic, and the Glucocard
Expression Meter Basic and will be free of duty and the Merchandise Processing Fee (MPF) upon
importation into the United States.
Please note that the additional duties imposed by heading 9903.01.25 do not apply to goods for which entry is
properly claimed under a provision of chapter 98 of the HTSUS, except for goods entered under headings
9802.00.40, 9802.00.50, 9802.00.60, and 9802.00.80. For headings 9802.00.40, 9802.00.50, and 9802.00.60,
the additional duties apply to the value of repairs, alterations, or processing performed abroad, as described in
the applicable heading. For heading 9802.00.80, the additional duties apply to the value of the article less the
cost or value of such products of the United States, as described in heading 9802.00.80.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS
and the accompanying duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Jason Christie at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division