N351310

N351310 October 10, 2025 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 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 fo

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