N348517

N348517 May 16, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9027.50.4015; 9903.01.25; 9817.00.96 William Benedict PTS Diagnostics 4600 Anson Boulevard Whitestown, IN 46075 RE: The tariff classification of blood testing meter systems from Malaysia Dear Mr. Benedict: In your letter dated May 2, 2025, you requested a tariff classification ruling. Descriptive literature was provided for our review. The items under consideration are the AlCNow+ and the AlCNow Self Check HbAlc blood testing meter systems, which are systems intended to quantitatively measure the percentage of glycated hemoglobin in fresh capillary blood samples from the fingertip. The primary difference between the AlCNow+ and the AlCNow Self Check is that the AlCNow+ is typically used in professional settings and has a larger number of test cartridges included in the kit (quantity of ten or twenty depending on the set) versus the AlCNow Self Check (quantity of four). The meters operate by performing a chemical and optical analysis of the blood. The A1CNow+ measures 8.62 inches by 4 inches by 6.47 inches and weighs 489 grams. The A1CNow Self Check measures 7.25 inches by 4.25 inches by 3.44 inches and weighs 174 grams. To perform the test, a person using the lancet device deploys the lancet by pricking their finger to draw blood before touching the capillary edge of the blood collector with the blood drop. The user then inserts the blood collector into the shaker body. The user then shakes the shaker body vigorously for approximately 5 seconds before standing the shaker on a table. The meter test cartridge is then prepared for use. The user then opens the test cartridge packet and inserts it into the meter, checking to ensure that the identification code on the cartridge matches the code on the body of the meter. The meter self-activates upon the insertion of the cartridge and will display a “WAIT” message on the LCD screen. Once it is ready for the sample, the meter will read “SMPL” on the screen. At this time, the user removes the shaker’s protective base and pushes the shaker into a circular opening on the cartridge which dispenses the diluted sample into the cartridge. The meter then runs the test, which takes five minutes to provide a result. If the test has run properly, the meter will display a “QCOK” message, followed by the user's AlC level, and an indication of the number of tests left on the meter. The user is able to track their AlC levels over the course of several months to assist the user in monitoring and managing their diabetes. These meter kits are designed, marketed, and sold for individual patient use, either by the patient or medical professional, and are not for use in the diagnosis or screening of diabetes mellitus. Unlike daily blood glucose meters, A1C tests give a measure of the average blood glucose over the previous 2-3 months. Therefore, daily A1C testing is not necessary for over the counter customers. A1C Now+ systems are often used daily by professionals in monitoring patients for diabetes during clinical visits. 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 goods consist 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., A1C testing). Finally, the articles are put up in a manner suitable for sale directly to users without repacking. Therefore, the goods in question are 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 is imparted by the A1C meter. In your letter, you suggest classification of the AlCNow+ and the AlCNow Self Check HbAlc blood testing meter systems under subheading 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.” We disagree. While the systems will be classified within heading 9027, HTSUS, the devices utilize an optical element along with the chemical element to perform the analysis. You state that the A1CNow analyzers utilize both immunoassay and chemistry technology to measure the A1C total hemoglobin, respectively. In operation, upon the addition of a diluted blood sample, blue microparticles conjugated to anti-A1C antibodies migrate along the reagent strip. The amount of blue microparticles captured on the strips reflect the amount of A1C in this sample. The optical component measures the amount of these blue microparticles. Since the analyzers utilize an optical component, subheading 9027.89, HTSUS, would not apply. Accordingly, the applicable subheading for the AlCNow+ and the AlCNow Self Check HbAlc blood testing meter systems is 9027.50.4015, 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 using optical radiations (ultraviolet, visible, infrared): Other: Electrical: Chemical analysis instruments and apparatus.” The general rate of duty will be free. 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 from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9027.50.4015, HTSUS, listed above. In your letter, you also requested consideration of a secondary classification for the subject AlCNow+ and the AlCNow Self Check HbAlc blood testing meter 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 no

of the blood. The A1CNow+ measures 8.62 inches by 4 inches by 6.47 inches and weighs 489 grams. The A1CNow Self Check measures 7.25 inches by 4.25 inches by 3.44 inches and weighs 174 grams. To perform the test, a person using the lancet device deploys the lancet by pricking their finger to draw blood before touching the capillary edge of the blood collector with the blood drop. The user then inserts the blood collector into the shaker body. The user then shakes the shaker body vigorously for approximately 5 seconds before standing the shaker on a table. The meter test cartridge is then prepared for use. The user then opens the test cartridge packet and inserts it into the meter, checking to ensure that the identification code on the cartridge matches the code on the body of the meter. The meter self-activates upon the insertion of the cartridge and will display a “WAIT” message on the LCD screen. Once it is ready for the sample, the meter will read “SMPL” on the screen. At this time, the user removes the shaker’s protective base and pushes the shaker into a circular opening on the cartridge which dispenses the diluted sample into the cartridge. The meter then runs the test, which takes five minutes to provide a result. If the test has run properly, the meter will display a “QCOK” message, followed by the user's AlC level, and an indication of the number of tests left on the meter. 

The user is able to track their AlC levels over the course of several months to assist the user in monitoring and managing their diabetes. These meter kits are designed, marketed, and sold for individual patient use, either by the patient or medical professional, and are not for use in the diagnosis or screening of diabetes mellitus. Unlike daily blood glucose meters, A1C tests give a measure of the average blood glucose over the previous 2-3 months. Therefore, daily A1C testing is not necessary for over the counter customers. A1C Now+ systems are often used daily by professionals in mo