N351409

N351409 January 23, 2026 CLA-2-38:OT:RR:NC:N3:139 CATEGORY: Classification TARIFF NO.: 3824.99.9397; 9817.00.96 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 

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 (