N349230

N349230 June 20, 2025 CLA-2-90:OT:RR:NC:N3135 CATEGORY: Classification TARIFF NO.: 4202.92.9100; 9018.39.0050; 9018.90.8000; 9027.89.4530; 9817.00.96 Michele Lehat Grunfeld Desiderio Lebowitz Silverman & Klestadt LLP 599 Lexington Ave FL 36 New York, NY 10022 RE: The tariff classification of Virta GK System and its components from China Dear Ms. Lehat: In your letter dated May 20, 2025, you requested a tariff classification ruling on behalf of Keto-Check, Inc. A sample was received and will be returned. Virta GK System is a battery-operated dual blood glucose and ketone monitoring system. The system is said to be comprised of one Virta GK Meter, ten Virta glucose test strips, ten Virta ketone test strips, one Virta blood glucose control solution, one Virta blood ketone control solution, one Virta lancing device, twenty sterile lancets, a user manual, package inserts, a quick reference guide, a warranty card, batteries, and a carrying case. The sample only includes one GK Meter with batteries, one Virta lancing device, a vial of glucose control solution level 2, a vial of ketone control solution level 2, a carrying case, a user manual, a quick reference guide, and package inserts. Glucose and ketone measurement 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. The Virta GK System can also transmit real-time data to the patient’s clinical care team. To use the Virta 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. Once the amperometric signal is measured, the meter calculates and displays the corresponding glucose or ketone concentration. The Virta GK System is intended for the quantitative measurement of glucose or ketone concentrations in fresh capillary whole blood samples obtained from the fingertips. The Virta GK Meter is a battery-powered device designed to deliver glucose and ketone measurements to the intended user. The meter is intended for use with compatible test strips, lancets, and control solutions. The device provides real-time blood glucose or ketone readings to the user via the LED display on the front of the meter or can transmit real-time data to the patient’s clinical team using the equipped Bluetooth functionality. The Virta lancing device is a pen-like device. It consists of a cap having a dial with five depth settings, a connecting collar, a lancet holder, a lancet ejector, a reset handle (spring loader), a release button, and a plastic housing. The lancet is a sterile, single-use device. Based on online research, it is a metal needle like article encased in a plastic holder with a plastic cap. The lancet will be inserted in the lancing device and when activated, the lancing device propels the lancet into the skin to obtain a blood sample for testing. The bi-fold case (carrying case) is constructed with an outer surface of textile. You have indicated in your letter that it is composed of polypropylene fiber, which is considered a man-made fiber in this form. The case has a zipper around three sides, and two interior mesh pockets. 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 Virta GK Meter. Accordingly, as you suggest in your letter, the applicable subheading for the complete Virta 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. The applicable subheading for the Virta GK Meter when imported separately 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. The applicable subheading for the lancets when imported separately will be 9018.39.0050, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other: Other.” The general rate of duty will be free. The applicable subheading for the Virta lancing Device when imported separately will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: Other instruments and appliances and parts and accessories thereof: Other: Other.” The general rate of duty will be free. The applicable subheading for the carrying case when imported separately will be 4202.92.9100, HTSUS, which provides for other containers and cases, with outer surface of sheeting of plastic or of textile materials, other, other, with outer surface of textile materials, of man-made fibers (except jewelry boxes of a kind normally sold at retail with their contents). The general rate of duty will be 17.6 percent ad valorem. In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of

(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. The applicable subheading for the Virta GK Meter when imported separately 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. The applicable subheading for the lancets when imported separately will be 9018.39.0050, HTSUS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other: Other.” The general rate of duty will be free. 

The applicable subheading for the Virta lancing Device when imported separately will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: Other instruments and appliances