CLA-2-90:OT:RR:NC:N1:105
Robin W. Grover
Attorney
Grover Trade Law
1016 7th Street, S.E.
Washington, D.C. 20003
RE: The tariff classification of COVID-19 test kits imported from the Dominican Republic
Dear Mr. Grover:
In your letter dated April 1, 2022, on behalf of your client, Lucira Health, Inc., you requested a tariff classification ruling.
The first item under consideration is described as the Lucira Check-It COVID-19 Test kit. The device is a single use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. The Covid test kits have two main components, the Sample Vial and the Test Unit, which has been described below in item three. The Sample Vial is a single use, disposable unit containing an elution buffer to release and lyse virions from a nasal swab sample. It comprises of an injection molded plastic tube which contains elution buffer, a bottom foil seal, and a peelable top foil. The tube includes an integrated lip cap with a venting membrane. Additional items contained in the kit include a nasal swab, two AA batteries, instructions, and a plastic disposal bag. The Check-It COVID-19 Test kit is designed for home use.
The second item under consideration is the Lucira All-in-One COVID-19 Test Kit, which is constructed of the same components and materials and is virtually identical to Lucira’s Check-It Test Kit, however, is targeted primarily for purchase and use by the medical community.
The third item under consideration is the Test Unit (also known as the Diagnostic Module) when imported separately. The Test Unit is the largest part of the two major kit components. The individual components of the Test Unit include the following: 1) Lyophilized pellets that act as chemical reagents and which are incorporated in certain chambers of the fluidic module. 2) An electronics subsystem comprised of an In-circuit microcontroller, light emitting diodes (LEDs), photosensor, heating element, temperature sensor, four indicator LEDs, battery voltage measurement circuitry, and serial interface. 3) A spike insert for the chip. 4) A bracket made of ABS. 5) A protective gasket made of rubber. 6) A thermal gap pad made of thermally conductive laminate. 7) Self-sealing vents consisting primarily of polyethylene. 8) Software, which runs on a microcontroller that coordinates and analyzes the results of a multiplexed molecular diagnostic assay. The embedded software is responsible for controlling temperature, measuring optical absorption of each reaction chamber over time, analyzing optical absorption signals, and rendering a diagnostic result to the user via LED indicators. 9) Plastic housing.
In operation, the Lucira Health COVID-19 test uses a proprietary, molecular-based detection process through the application of chemical reagents to detect genomic RNA from SARS-CoV-2. The Test Unit applies reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) for the detection of specific pathogenic genetic markers in patient samples. RT-LAMP is an isothermal gene amplification procedure in which the reaction proceeds in one step at a constant temperature, resulting in a very simple, robust reaction. It utilizes the Sample Vial that contains an elution buffer whereby an applied solvent enabling the swab contents to be eluted and lysed (decomposed) at room temperature, thereby releasing viral RNA for downstream detection.
Before nasal swab sample collection, the top foil is peeled off and placed on the Test Unit. After collection, the swab is swirled in the buffer to release the lyse sample material; the nasal swabs are thereby eluted in the Sample Vial, which is closed and pushed down into the Test Unit to run the test. The bottom foil seal punctures, allowing gravity loading of the tube’s contents into the reaction chambers within the Test Unit. The Test Unit needs Sample Vial engagement before the assay run is initiated. The test unit does not feature buttons or control interfaces but initiates when the user inserts the batteries.
Separate, lyophilized reagents in the Test Unit amplify the viral target by reaction. These reagents appear in the independent reaction chambers of a disposable transparent disk-shaped fluidic chip module connected to an electronic subsystem which amplifies and reports the test results. The outlet of each chamber is connected to an independent self-sealing vent that allows air to escape during filling but prevents liquid from leaking or evaporating from the chambers. The fluidic chip module containing the chambers is attached to a tiny, printed circuit board (PCB) containing reaction chamber LED’s, a photosensor, a resistive heating element, a thermistor, result indicator LED’s, and a microcontroller. A successful amplification reaction leads to a pH change of the reaction mixture and consequently a color change of the halochromic agents included in the elution buffer. This color change is detected, in real time, using optical and electronic elements contained within the Test Unit.
Initiation of the assay run starts with the resistive heating element warming the reaction mixture to the required temperature setpoints. The resistive heating element heats the chambers to the temperature needed for the amplification reaction to proceed. Light pipes integrated into the microfluid module guide light from LEDs arranged around the perimeter, through each reaction chamber, and to a common photosensor located on the tiny, printed circuit board under the center of the disk. As LEDs are sequentially illuminated, the microcontroller monitors the photosensor signal and tracks changes in optical absorbance across each reaction chamber. When the assay is finished, the result is displayed via the LED indicators. Results for the test are displayed separately as a positive, negative, or invalid. Positive or negative results may appear in eleven to thirty minutes. The result display persists for a minimum of twelve hours after the test is complete.
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. They consist of articles put up together to carry out specific activities (i.e., COVID-19 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 the Lucira Check-It COVID-19 Test Kit, the Lucira All-in-One Covid-19 Test Kit and the Test Unit is imparted by the electronic subsystem comprised of a microcontroller loaded with software used to analyze the results of the test.
In your letter, you compare three headings 3822, 9018, and 9027, HTSUS. While we agree with you that the Lucira Check-it COVID-19 Test Kit and All-in-One COVID-19 Test Kit are not classified in heading 9018, HTSUS, we disagree that they are classified in heading 3822, HTSUS, which provides, in relevant part, for “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits, other than those of heading 3006.” We have found that the essential character of the kits is imparted by the diagnostic module (test unit containing the electronic subsystem). The diagnostic modules contain lyophilized pellets that act as chemical reagents and they also include an electronic subsystem comprised of a microcontroller loaded with software, an in-circuit programming interface, Light Emitting Diodes (LEDs), a photosensor, a heating element, a temperature sensor, four indicator LEDs, a battery voltage measurement circuitry, and a serial interface. The microcontroller “coordinates and analyzes the result of a multiplexed molecular diagnostic assay.” “The embedded software is responsible for controlling temperature, measuring optical absorption of each reaction chamber over time, analyzing optical absorption signals, and rendering a diagnostic result to the user via light emitting diode (LED) indicators.” Although the diagnostic modules contain diagnostic reagents, the devices by themselves are not reagent preparations. Instead, they are sophisticated test devices used for in vitro diagnostic testing. Heading 3822, HTSUS, only describes one component of the diagnostic modules while heading 9027, HTSUS, describes the entire diagnostic modules as a single unit. As such, the test kits will not be classified in heading 3822, HTSUS.
Furthermore, you suggest the classification of the Lucira Check-It COVID-19 Test Kit, the Lucira All-in-One Covid-19 Test Kit, and the Test Unit when imported separately will be 9027.89.8090, 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: Other: Other.” We disagree. The Lucira Check-It COVID-19 Test Kit, the Lucira All-in-One Covid-19 Test Kit, and the Test Unit when imported separately function by using optical radiations to analyze chemical reactions, which is a process that is covered by subheading 9027.50, HTSUS.
Accordingly, the applicable subheading for the Lucira Check-It COVID-19 Test Kit, the Lucira All-in-One Covid-19 Test Kit, and the Test Unit when imported separately will be 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.
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 on the World Wide Web at https://hts.usitc.gov/current.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
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. You should also be aware that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
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, contact National Import Specialist Jason Christie at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division