N341988

N341988 August 15, 2024 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9027.89.4530; 9903.88.01; 9817.00.96 Eric Jordan Trividia Health Inc. 2400 NW 55th Ct. Fort Lauderdale, FL 33309 RE: The tariff classification of glucose monitoring systems from China Dear Mr. Jordan: In your letter dated August 9, 2024, you requested a tariff classification ruling. The items under consideration are the TRUENESS and the TRUENESS Air blood glucose monitoring systems (BGMs), which are systems intended to quantitatively measure glucose in fresh capillary blood from the fingertip. The primary difference between the TRUENESS and TRUENESS Air BGMs is the “Air” version contains Bluetooth capabilities. The meters operate by performing a chemical analysis on the blood and do not utilize any optical elements. To perform the test, the user starts by inserting the designated end of the test strip into the meter. The meter will turn on and prepare the meter for the test. Next, the user lances their finger using a lancet and lancing device to draw blood before touching the capillary edge of the test strip with the blood drop. The test result appears on the LED display in mg/dL. The user then has the option of adding a before or after meal tagging to the test result. The meter automatically stores up to 500 blood glucose results in memory with the time and date of the test. The meter also provides 7, 14, 30, and 90-day averaging. If the user’s blood glucose result is outside the measuring range of the meter, a warning is displayed, which will show the “LO” or “HI” result. Buttons on the display provide access to test results stored in memory or previously displayed fields. Additionally, for the TRUENESS Air Meter System, the data can be wirelessly transferred to another paired device. The system is designed, marketed, and sold for individual patient use and is not for use in the diagnosis or screening of diabetes mellitus. There are two versions of the TRUENESS Metering Systems. Version 1 will include the blood glucose meter, carrying case, owners’ book, quick reference guide, logbook, and batteries. Version 2 will include the blood glucose meter, carrying case, owners’ book, quick reference guide, logbook, batteries, lancing device, control solution, lancets, and TRUENESS Blood Glucose Test Strips. The kits measure 4.5” x 2” x 6.375” and weigh .44lbs. 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., glucose monitoring). 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 the opinion of this office that the essential character of both versions are imparted by the blood glucose monitor. Accordingly, as suggested in your letter, the applicable subheading for both versions of the TRUENESS and the TRUENESS Air blood glucose monitoring systems 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. Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9027.89.4530, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9027.89.4530, HTSUS, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china respectively. In your letter, you also requested consideration of a secondary classification for the subject TRUENESS and the TRUENESS Air blood glucose monitoring systems under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as including “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 oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” We note that in HQ 56120 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. 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. In N292225 dated December 18, 2017, CBP held that Insulet’s Insulin Delivery Omnipod was classified under 9817.00.96 for secondary classification purposes. Additionally, as discussed in Headquarters ruling 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).” The TRUENESS and the TRUENESS Air blood glucose monitoring systems perform a chemical analysis on a diabetic’s blood sample to determine if their levels are too high or too low, which is a direct link to the physical impairment. Accordingly, based on the information provided, it is the opinion of this office that the TRUENESS and the TRUENESS Air blood glucose monitoring systems are specifically designed for use by the handicapped for secondary classification purposes. 

on the blood and do not utilize any optical elements. To perform the test, the user starts by inserting the designated end of the test strip into the meter. The meter will turn on and prepare the meter for the test. Next, the user lances their finger using a lancet and lancing device to draw blood before touching the capillary edge of the test strip with the blood drop. The test result appears on the LED display in mg/dL. The user then has the option of adding a before or after meal tagging to the test result. The meter automatically stores up to 500 blood glucose results in memory with the time and date of the test. The meter also provides 7, 14, 30, and 90-day averaging. If the user’s blood glucose result is outside the measuring range of the meter, a warning is displayed, which will show the “LO” or “HI” result. Buttons on the display provide access to test results stored in memory or previously displayed fields. Additionally, for the TRUENESS Air Meter System, the data can be wirelessly transferred to another paired device. The system is designed, marketed, and sold for individual patient use and is not for use in the diagnosis or screening of diabetes mellitus.There are two versions of the TRUENESS Metering Systems. Version 1 will include the blood glucose meter, carrying case, owners’ book, quick reference guide, logbook, and batteries. Version 2 will include the blood glucose meter, carrying case, owners’ book, quick reference guide, logbook, batteries, lancing device, control solution, lancets, and TRUENESS Blood Glucose Test Strips. The kits measure 4.5” x 2” x 6.375” and weigh .44lbs.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. G