RE: The tariff classification of the Keto-Mojo GK+ System from China

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 N365911 October 22, 2026 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9027.89.4530; 9817.00.96 Michele Lehat Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP 599 Lexington Avenue, floor 36 New York, NY 10022 RE: The tariff classification of the Keto-Mojo GK+ System from China Dear Ms. Lehat: In your letter dated October 8, 2026, on behalf of your client, Keto-Check, Inc., you requested a tariff classification ruling. Descriptive literature was provided for our review. The item under consideration is described as the Keto-Mojo GK+ System, which is designed for the quantitative measurement of glucose and/or -ketone concentrations in fresh capillary whole blood samples obtained from the fingertips. It is designed for use by individuals with diabetes in a home setting as an aid to monitor the effectiveness of diabetes management. The system is comprised of a Keto-Mojo GK+ Meter, ten Keto-Mojo glucose test strips, ten Keto-Mojo ketone test strips, one Keto-Mojo blood glucose control solution, one Keto-Mojo blood ketone control solution, one lancing device, twenty sterile lancets, a user manual, package inserts, a quick reference guide, a warranty card, batteries, and a carrying case. To use the Keto-Mojo GK+ System, the user employs the lancing device to prick the fingertip and produce a drop of blood. The blood is then applied to a ketone or glucose test strip inserted into the meter. The glucose and ketone measurements are performed using an amperometric detection method. The test is based on the measurement of an electrical current generated by the reaction between glucose in the blood sample and reagents located on the electrode of the test strip. When a blood sample is applied, it is drawn into the tip of the test strip by capillary action. The glucose present in the sample reacts with a glucose or ketone-specific enzyme and mediator, generating electrons and producing a current. The strength of the electrical current is positively correlated with the glucose concentration in the sample. Following the reaction period, the glucose or ketone concentration is displayed on the device. General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in part that for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes. Goods that are, prima facie, classifiable under two or more headings, are classifiable in accordance with GRI 3, HTSUS. GRI 3(a) states, in part, that when two or more headings each refer to part only of the items in a set put up for retail sale, those headings are to be regarded as equally specific, even if one heading gives a more precise description of the good. The instant good consists of at least two different articles that are, prima facie, classifiable in different subheadings. It consists of articles put up together to carry out a specific activity (i.e., blood analysis). Finally, the articles are put up in a manner suitable for sale directly to users without repacking. Therefore, the good in question is within the term “goods put up in sets for retail sale.” GRI 3(b) states, in part, that goods put up in sets for retail sale, which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component which gives them their essential character. It is our opinion that the essential character of the kit is imparted by the Keto-Mojo GK+ Meter. Accordingly, the applicable subheading for the Keto-Mojo GK+ System will be 9027.89.4530, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus: Other: Other: Electrical: Chemical analysis instruments and apparatus.” 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: “[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 9817.00.96, 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. We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection (CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of U.S. Note 4(a) to Chapter 98 of the HTSUS. Additionally, as discussed in HQ 964169 (dated June 26, 2001), “people with diabetes are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea, dizziness and fainting. This interferes with working, a major life activity. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note 4(a).” In HQ 562869 (dated December 23, 2003), CBP held that a pump designed for individuals suffering from diabetes or glucose control problems was an article specifically designed or adapted for the handicapped and is properly classified under 9817.00.96 for secondary classification purposes. CBP has previously ruled that glucose monitoring systems (NY ruling N341988, dated August 15, 2024), diabetic pen needles and lancets (HQ H110795, dated August 5, 2011), a lancing device and lancets (NY ruling N348999 dated June 11, 2025), and carrying cases specifically designed to hold and carry blood glucose meters (HQ 563264, dated May 6, 2005), qualified for duty-free treatment under subheading 9817.00.96, HTSUS. The Keto-Mojo GK+ System is specifically designed for use by diabetic persons in a home setting to perform a chemical analysis on a blood sample to determine if their levels are too high or too low. Based on the information provided and the precedents, it is the opinion of this office that the Keto-Mojo GK+ System is specifically designed for use by the handicapped. Therefore, we agree that secondary classification 9817.00.96, HTSUS, would apply to the Keto-Mojo GK+ System and will be free of duty and the Merchandise Processing Fee (MPF) upon importation into the United States. 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 Jason Christie at jason.m.christie@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division