CLA-2-38:OT:RR:NC:N3:139
Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW ,Suite 300
Washington, DC 20006
RE: The tariff classification and eligibility under the Nairobi Protocol of four control solutions from South
Korea
Dear Mr. Finkelstein:
In your letter dated July 14, 2025, you requested a tariff classification ruling, on behalf of your client i-SENS
USA. Documentation submitted with your ruling request was forwarded to the Customs and Border
Protection Laboratory for analysis. This analysis has been completed.
The products under consideration are four i-SENs USA’s control solutions (CareSens Control A, Normal,
CareSens Control A, B Normal - High, Company 1 Control A, B Normal - High, Company 2 Control A, B
Normal - High) which are used to calibrate I-SENS USA’s, and two other company’s blood glucose meters.
They are aqueous solutions with a precise concentration of glucose, used to verify the accuracy and
calibration of blood glucose meters. You state that the “normal” control solutions, which are marked as
container “A,” contain a glucose concentration that falls within the typical blood glucose range for
non-diabetic persons. The “high” control solutions, which are marked as container “B,” contain a
significantly elevated glucose concentration, simulating hyperglycemic conditions. Using both solutions
verifies that the meter can accurately detect and report glucose levels across a clinically relevant range. If
readings from both fall within the acceptable target ranges printed on the test strip vial or control solution
packaging, this indicates that the blood glucose meter system is functioning correctly. When the control
solution is applied to a test strip, the meter should return a reading within a predefined range printed on the
test strip vial. This process checks the performance of the meter and test strips, ensuring the system's
electrochemical sensor and algorithm are functioning correctly, without relying on patient blood samples.
You state that the control solutions are designed solely for the use of persons afflicted who must regularly
monitor their blood glucose levels using products such as the blood glucose meters and test strips to manage
their condition.
You suggest classification of the four control solutions in subheading 3822.19.0030, Harmonized Tariff
Schedule of the United States (HTSUS), as other laboratory reagents. However, based on our laboratory
analysis, the four control solutions are used to perform quality control checks on the i- SENS USA’s meter
and strips and are used to ensure the reliability and accuracy of blood glucose readings. They are not involved
in a chemical reaction, nor are their functions based on an observable or measurable change. Hence, they are
not considered reagents of heading 3822, HTSUS.
The applicable subheading for the four i-SENs USA’s control solutions will be 3824.99.9397, HTSUS, which
provides for “ Prepared binders … chemical products and preparations … (including those consisting of
mixtures of natural products), not elsewhere specified or included: Other: …Other”.. The general rate of duty
will be 5 percent ad valorem.
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 of South Korea
will be subject to an additional ad valorem rate of duty of 15 percent. Your product falls within an excepted
subheading. At the time of entry, you must report the Chapter 99 heading applicable to your products
classification, i.e. 9903.01.32, in addition to subheading 3824.99.9397, HTSUS, listed above.
In your submission you requested consideration of a secondary classification under subheading 9817.00.96,
HTSUS, which covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other
physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and
artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.”
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“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 one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314. The Court of Appeals for
the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the
merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than
for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection
(CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
We note that CBP has consistently ruled that persons with diabetes are considered physically handicapped
within the meaning of U.S. Note 4(a). See e.g., HQ 964169, dated June 26, 2001, HQ 561283, dated August
26, 1999, and HQ 561020, dated October 14, 1998. CBP has previously ruled that the glucose test strips for
glucose test meters (HQ H039775, dated April 17, 2009, and HQ 562887, dated January 7, 2004) qualified
for duty-free treatment under subheading 9817.00.96, HTSUS. The instant blood glucose test strips are
specially designed for the use or benefit of people with diabetes, enabling them to monitor their blood sugar
levels regularly when used with the blood glucose meters. Based on the precedents, it is the opinion of this
office that the four i-SENs USA’s control solutions qualify for duty-free treatment under subheading
9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 John Bobel at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division