The country of origin of PCR and Genetic Analyzers

N333453 July 5, 2023 OT:RR:NC:N1:105 CATEGORY: Origin Jun Nagayoshi Bioer Life Science Japan Co., Ltd. BMA210 1-5-5 Minatojima-minamimachi, Chuo-kuKobe 6500047Japan RE: The country of origin of PCR and Genetic Analyzers Dear Mr. Nagayoshi: In your letter dated June 12, 2023, you requested a country of origin ruling on polymerase chain reaction (PCR) and Genetic Analyzers. The first item under consideration is the QuantGene 9600 Fluorescent Quantitative Detection System (FQD-96C). The device is an automated instrument used for quantitative detection of analytes in the related pathogen nucleic acids (DNA/RNA) from human samples using the polymerase chain reaction (PCR) process. The samples can be nasopharyngeal and oropharyngeal samples, whole blood, blood plasma, blood serum, or saliva. The instrument is designed for in vitro diagnostic only and is a standalone instrument that can be applied to various PCR detection kits. The QuantGene 9600 Fluorescent Quantitative Detection System is intended for use in medical and biological laboratories. The second item under consideration is the LineGene Mini S Fluorescent Quantitative Detection system (FQD-16B). The device is based on the principle of fluorescent quantitative PCR and is used together with matching detection reagents. It is used for qualitative and quantitative detection of analytes in nucleic acid samples (DNA/RNA) from the human body, including pathogens and human gene items. The real-time fluorescence quantitative PCR analyzer is mainly composed of control parts, hot cover parts, thermal cycle parts, photoelectric components, power supply components and software. The third item under consideration is the GenePure Pro Nucleic Acid Purification System (NPA-32P). The system is an automated instrument used for extraction and purification of pathogen nucleic acid in various human clinical samples such as swab samples, whole blood, blood plasma, blood serum, and urine. The device adopts magnetic bead extraction technology to extract and purify nucleic acid through a precision transmission and controlling step motor by a single chip microcomputer. It features an embedded real time operating system, transparent working chamber (facilitating the observation of working conditions), and a large LCD panel. The GenePure Pro Nucleic Acid Purification System is intended for use in medical and biological laboratories. The QuantGene 9600 Fluorescent Quantitative Detection System is assembled in Japan using Chinese subassemblies and components. Step one involves attaching the power supply to the support with screws. Next the assembler will press the power supply fixing plate against the power supply switch and affix with glue. Then the main board is fastened to the device with screws. This is followed by attaching the monitor with screws and plugging in the wires to the allocated slots. Once the monitor powers on, the assembler will verify the serial number display and allow the guide rail assembly to automatically slide together with the temperature control module, which was fastened with screws and glue. All wires are then pressed into place to the main printed circuit board. Finally, the external components are fastened with screws and the wires are zip tied in place.   The LineGene Mini S Fluorescent Quantitative Detection system is assembled in Japan using Chinese subassemblies and components. The process starts by disassembling the brackets, substrate assembly, and board by unscrewing fasteners and disconnecting wires. Then the control components can be properly mounted using screws and pressing cables into the appropriate slots. Each component contains several screws (some with insulating washers) that need to be affixed. Next the HDMI cables are connected to the main board and the HDMI bracket is affixed with screws. Once all of the cables are attached, they are secured with cable ties. The next step is mounting the temperature and control unit and affixing with screws. The touch screen is mounted using screws, and the cable is connected to the circuit board and affixed with hot melt adhesive. The EMC shield is pressed into place and secured with double sided tape. Finally, the main unit is attached with screws and the remaining exterior components are screwed into place. The GenePure Pro is assembled in Japan using Chinese subassemblies and components. The first step involves mounting the control components using washers and screws, similar to the devices above. The next step involves screwing in the power supply and routing the associated cables through the hole in the metal body. The next step is wiring the different components to the boards with numerous harnesses. This step involves screwing some wires into place or pressing the harness wires into the appropriate slots. The next step involves mounting the display unit and microswitch with several screws and pressing the wires into place. The final steps involve mounting and screwing the exterior components and securing wires with cable ties. Pursuant to Part 134, Customs Regulations (19 CFR §134) implements the country of origin marking requirements and exceptions of 19 USC 1304. Section 134.1(b), Customs Regulations (19 CFR § 134.1(b)), defines “country of origin” as: “[t]he country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the ‘country of origin’ within the meaning of this part.” A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In order to determine whether a substantial transformation occurs when components are assembled into completed products, all factors such as the components used to create the product and manufacturing processes that these components undergo are considered in order to determine whether a product with a new name, character, and use has been produced. No one factor is decisive, and assembly/manufacturing operations that are minimal will generally not result in a substantial transformation. In the aforementioned scenarios concerning the QuantGene 9600 Fluorescent Quantitative Detection System, the LineGene Mini S Fluorescent Quantitative Detection system, and the GenePure Pro Nucleic Acid Purification System, it is our opinion that the operations performed in Japan would be considered simple assembly. Each operation includes screwing the parts in place, gluing components, and pressing the wiring harnesses into the appropriate slots. We find that the manufacturing of the subassemblies in China, specifically the printed circuit boards and other control components, provide the essence of the finished articles. Accordingly, it is the opinion of this office that the country of origin of the QuantGene 9600 Fluorescent Quantitative Detection System, the LineGene Mini S Fluorescent Quantitative Detection system, and the GenePure Pro Nucleic Acid Purification System will be China. Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the assumption that all of the information furnished in connection with the ruling request and incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and complete in every material respect. The application of a ruling letter by a [CBP] field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based.” 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