N346345

N346345 March 20, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 3926.90.9910; 9027.90.5650 Ellen Pizarek Sonic Reference Laboratory 3800 Quick Hill Rd., Building 3, Suite 101 Austin, TX 78753 RE: The tariff classification of the Genotizer 20K Well Chip and the D_PCR Chip Case from South Korea Dear Ms. Pizarek: In your letter dated February 27, 2025, you requested a tariff classification ruling. Descriptive literature and pictures were provided for our review. The first item under consideration is described as the Genotizer 20K Well Chip. The chip is made of plastic and is approximately 0.75 inches by 1.5 inches in size. It contains an array of over 20,000 microwells and is used with a Lab On An Array (LOAA) analyzer or an LOAA-M System for detection and quantification of nucleic acid targets. The LOAA is used for single runs, while the LOAA-M can be used for up to 16 runs. The chip also includes an Electrically Erasable Programmable Read-Only Memory (EEPROM) element for storing specimen identification (barcode information). The memory is not capable of storing any information other than the specimen identification and is not required to be used for a run on the analysis machine. The primary function of the chip is to securely hold the polymerase chain reaction (PCR) mixture, however, it is imported empty. Each chip is single use only and is then discarded. The second item under consideration is described as the D_PCR Chip Case. The round, clamshell-style case is approximately 2 inches in diameter and holds the Genotizer 20K Well Chip in place on the analyzer. The chip case also contains a heating element (thermal cycler) and a fluorescent sensor, along with an electronic control system that connects to the EEPROM element of the chip and the analyzer. The chip case can be used up to 100 times before needing to be discarded. In operation, the user would prepare a PCR mixture. The mixture would then be injected into the Genotizer 20K Well Chip, with the cap then closed to secure and seal the mixture. The chip is then inserted into the D_PCR Chip Case and the lid of the case is closed. The user then places the chip case into the LOAA analyzer ensuring that the case connection points are lined up properly with the analyzer connection points. Once in place, the LOAA machine will perform the real time PCR. Results are automatically analyzed and saved to the analyzer. To identify the target in a positive PCR reaction, the LOAA performs a fluorescence amplification curve analysis. During each PCR cycle, multiple images of the PCR well array are captured, fluorescence levels of valid wells are calculated, and the fluorescence amplification curve is generated at each PCR cycle by the software installed in the LOAA. The curve is then evaluated to determine if there is a valid PCR reaction through the PCR control reaction analysis. If a PCR reaction is detected in the sample, it is then delivered to the user. Validation of proper operation of the optical system included in the LOAA Analyzer is monitored through a device self-check operation and cartridge PCR control reactions. The digital PCR system has been used in many genetic fields such as target gene quantification, cancer-related mutations, genomic alterations, and gene expression. “Accessories” are classified in accordance with Chapter 90 Note 2 which states that, subject to note 1 above, parts and accessories for machines, apparatus, instruments or articles of this chapter are to be classified according to the following rules: (a) Parts and accessories which are goods included in any of the headings of this chapter or of chapter 84, 85 or 91 (other than heading 8487, 8548 or 9033) are in all cases to be classified in their respective headings; (b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machines, instruments or apparatus of that kind; (c) All other parts and accessories are to be classified in heading 9033. In applying Note 2(b) to Chapter 90, we find that the subject D_PCR Chip Case is an accessory that can only be used with the LOAA On-Point and LOAA-M On-Point Instruments. Further, the instruments also require a certain type of case that has the associated connections available with the D_PCR Chip case. On the other hand, the chip is solely used to store the PCR mixture and go into the case. Any chip of roughly the size and shape of the Genotizer 20K Well Chip would be suitable. It is predominately made of plastic and does not have any features that make it solely useable with the case or the analyzer. Therefore, we do not consider the Genotizer 20K Well Chip an accessory. Accordingly, the applicable subheading for the Genotizer 20K Well Chip will be 3926.90.9910, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other articles of plastics and articles of other materials of headings 3901 to 3914: Other: Other: Laboratory ware.” The general rate of duty will be 5.3 percent ad valorem. The applicable subheading for the D_PCR Chip Case will be 9027.90.5650, 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: Microtomes; parts and accessories: Parts and accessories: Of electrical instruments and apparatus: Other: Of instruments and apparatus of subheading 9027.20, 9027.30, 9027.50, 9027.81 or 9027.89: Of articles of subheading 9027.50.40.” 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 at https://hts.usitc.gov/. 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, Steven A. Mack Director National Commodity Specialist Division

machine. The primary function of the chip is to securely hold the polymerase chain reaction (PCR) mixture, however, it is imported empty. Each chip is single use only and is then discarded. The second item under consideration is described as the D_PCR Chip Case. The round, clamshell-style case is approximately 2 inches in diameter and holds the Genotizer 20K Well Chip in place on the analyzer. The chip case also contains a heating element (thermal cycler) and a fluorescent sensor, along with an electronic control system that connects to the EEPROM element of the chip and the analyzer. The chip case can be used up to 100 times before needing to be discarded. In operation, the user would prepare a PCR mixture. The mixture would then be injected into the Genotizer 20K Well Chip, with the cap then closed to secure and seal the mixture. The chip is then inserted into the D_PCR Chip Case and the lid of the case is closed. The user then places the chip case into the LOAA analyzer ensuring that the case connection points are lined up properly with the analyzer connection points. Once in place, the LOAA machine will perform the real time PCR. Results are automatically analyzed and saved to the analyzer. To identify the target in a positive PCR reaction, the LOAA performs a fluorescence 

amplification curve analysis. During each PCR cycle, multiple images of the PCR well array are captured, fluorescence levels of valid wells are calculated, and the fluorescence amplification curve is generated at each PCR cycle by the software installed in the LOAA. The curve is then evaluated to determine if there is a valid PCR reaction through the PCR control reaction analysis. If a PCR reaction is detected in the sample, it is then delivered to the user. Validation of proper operation of the optical system included in the LOAA Analyzer is monitored through a device self-check operation and cartridge PCR control reactions. The digital PCR system has been used in many genetic fields such a