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 a control solution from South Korea
Dear Mr. Finkelstein:
In your letter dated July 16, 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.
i-SENs USA’s control solution, KetoSens -Ketone Control Solution A, B Normal - High, is used to test the
accuracy of i-SENS USA’s blood ketone meters and test strips. The control solution is an aqueous solution
packaged in 4ml vials containing a precise concentration of beta hydroxybutyrate—a ketone body produced
by the liver during periods of low glucose availability—and is used to verify the accuracy and calibration of
blood ketone meters and test strips. 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. The “normal” control solutions, which are marked as
container “A,” contain a hydroxybutyrate concentration that falls within the typical blood ketone range for
non-diabetic persons. The “high” control solutions, which are marked as container “B,” contain a
significantly elevated hydroxybutyrate concentration, simulating ketoacidocic conditions. Using both
solutions verifies that the meter can accurately detect and report ketone 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 ketone meter system is functioning correctly. You state that
the control solutions are designed solely for the use of persons afflicted with diabetes 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 control solution (A and B) in Heading 3822, Harmonized Tariff Schedule of
the United States (HTSUS), as other prepared diagnostic or laboratory reagents. However, based on our
laboratory analysis, the control solution (A and B) is used to perform quality control checks on the accuracy
of i- SENS USA’s meter and strips and used to ensure the reliability and accuracy of blood ketone 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 i-SENs USA’s control solution KetoSens -Ketone Control Solution A, B
Normal - High 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.
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 i-SENs USA’s control solution KetoSens -Ketone Control Solution A, B Normal - High qualify
for duty-free treatment under subheading 9817.00.96, HTSUS.
The 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/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
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