RE: The tariff classification of Glucose Dehydrogenase “Amano” 8 from Japan

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N364610 September 14, 2026 CLA-2-35:OT:RR:NC:N3 135 CATEGORY: Classification TARIFF NO.: 3507.90.7080 Andrea Jeglum Sandler, Travis & Rosenberg, P.A. 100 Trade Center, Suite G-700 Woburn, MA 01801 RE: The tariff classification of Glucose Dehydrogenase “Amano” 8 from Japan Dear Ms. Jeglum: In your letter dated August 26, 2026, on behalf of Amano Enzyme U.S.A. Co. Ltd., you requested a tariff classification ruling. The product under consideration is Glucose Dehydrogenase “Amano” 8 (GDH-8), imported in bulk for use in the manufacture of blood glucose test strips. GDH-8 is a unique and specially formulated microbial enzyme, also known as glucose 1-dehydrogenase, with CAS No. 37250-84-3. It is the key ingredient in the chemical solution used in the manufacture of blood glucose test strips. These test strips are designed for use only with a specific self-monitoring blood glucose meter system (Blood Glucose Meter). They are inserted into the system, after which blood is drawn into the monitor’s sample tip and the blood sample comes into contact with the test strip in the sample tip. The GDH-8 on the test strip oxidizes glucose from the blood sample, creating a redox reaction that releases electrons, allowing the mediator to carry electrons to the electrode, which creates a tiny electrical current that can be read by the meter. The GDH-8 is responsible for this electron-transfer chain that provides the glucose sensing, which is the essential function of a blood glucose meter or monitor for diabetic care. You claim that while glucose dehydrogenase has other limited industrial applications in the marketplace, the subject GDH-8 does not. You further state that the GDH-8 enzyme is the critical component of the test strip because it reacts with the blood to detect the glucose level that is read by the meter. Without the GDH-8, the test strip could not react with the blood to detect the glucose, and the meter could not read the glucose level to inform the patient and thus perform the key function of the Blood Glucose Meter. The applicable subheading for the GDH-8 will be 3507.90.7080, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Enzymes; prepared enzymes not elsewhere specified or included: Other: Other: Other.” The general rate of duty will be free. In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “Articles 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: Other.” 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 9817.00.96, 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. In your letter, you assert that the GDH-8 qualifies for duty-free treatment under subheading 9817.00.96, HTSUS, as a part of a blood glucose test strip specially designed or adapted for physically or mentally handicapped persons. We disagree. CBP has previously ruled that blood glucose test strips for use with blood glucose meters qualified for duty-free treatment under subheading 9817.00.96, HTSUS. See HQ H039775, dated April 17, 2009, and HQ 562887, dated January 7, 2004. While the GDH-8 enzyme is necessary to the test strip’s function, it is a raw chemical material in the chemical solution applied to the strip and not a separate mechanical or structural item. It is a constituent material or ingredient rather than an identifiable part of the test strip. Moreover, even if the GDH-8 could be considered a component of the test strip, it would not be classified as a “part” for tariff purposes. In Schick X-Ray Co. v. United States, 271 F. Supp. 305 (1967), the court stated that, “[m]any …objects, despite the fact that their usefulness is only in conjunction with other articles, retain a separateness of identity and a functional self-sufficiency which preclude their classification as parts.” In this case, the bulk GDH-8 retains a separateness of identity and a functional self-sufficiency as an enzyme. Accordingly, the imported bulk GDH-8 is a raw, unshaped chemical material and not a “part” of a blood glucose test strip for purposes of 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 the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division