CLA-2-90:OT:RR:NC:N1:105
Robert Leo Meeks, Sheppard, Leo & Pillsbury LLP 570 Lexington Avenue, Suite 2405 New York, NY 10022
RE: The tariff classification of quantitative polymerase chain reaction devices from Singapore
Dear Mr. Leo:
In your letter dated December 12, 2023, on behalf of your client, Bio-Rad Laboratories, Inc., you requested a tariff classification ruling.
The items under consideration are described as the CFX Opus 96 Dx and CFX Opus 384 Dx qPCRs (Quantitative polymerase chain reaction). Both instruments work in a manner similar to one another, as seen below.
With their thermal gradient feature, the systems allow the user to optimize the assay in a single experiment, minimizing the use of separate samples and reagents. The solid-state optical technology of the CFX Opus Systems provides sensitive detection for precise quantification and target discrimination. Scanning just above the sample plate, the optics shuttle individually illuminates and detects fluorescence from each well with high sensitivity and consistency. The CFX Opus 96 System can discriminate between up to five targets in a single reaction well. The optical filter sets are designed to maximize fluorescence detection for specific dyes in specific channels. The CFX Opus 384 System offers all the same benefits with up to four targets per well. The CFX Opus 96 well is the most common block for general throughput and maximized multiplexing. The six-LED system allows five channels for multiplexing and an additional channel for fluorescence resonance energy transfer (FRET) applications. The system works well for most gene expression and genotyping workflows, as well as advanced applications. The CFX Opus 384 is for workflows utilizing small volumes and higher throughput. This five-LED system supports four-channel multiplexing as well as FRET applications in fewer runs than the 96 well counterpart.
A conventional polymerase chain reaction is used to amplify a target DNA sequence to several million in a short amount of time. It allows the replication of cellular genetic material using a polymerase enzyme to construct specific fragments of DNA. The polymerase enzyme works alongside a primer which is connected to a strand of DNA, allowing for the synthesis of specific parts of the DNA strand. The result of using primers in this way is the amplification of a chosen DNA sequence, up to millions or billions of copies. Conventional PCR is used in many areas of study, including medical and diagnostic research, forensic studies and research, selective DNA isolation, amplification and quantification of DNA. Quantitative PCR (qPCR), also called real-time PCR, or RT-PCR, is a variation of the standard polymerase chain reaction which uses just one machine to combine the amplification of a target DNA sequence with the quantification of the concentration of the DNA in any given reaction. This is done using fluorescence-detecting thermocyclers. Compared to conventional PCR, qPCR provides a faster alternative to facilitate analysis by detecting products in real-time during the exponential phase (instead of multiple hours). Fluorescent dyes signal DNA of interest, and the amount of fluorescence generated is determined by the quantity of DNA present.
Experiments on the CFX Opus 96 Dx or CFX Opus 384 Dx instruments are performed by regulated laboratories requiring an in vitro diagnostics (IVD) labeled instrument. Real-time PCR experiments utilize optimized assay specific primers and probes and master mix solutions (buffers, salts, DNA polymerase). Each assay uses a real-time PCR protocol optimized by the medical device manufacturer of the IVD kit in use by the laboratory. Upon completion of the real-time PCR experiment, the results from the CFX Opus 96 Dx and CFX Opus 384 Dx are analyzed on the CFX Maestro Dx SE software, which also provides the ability to chart and plot the data. The types of assays can include gene expression, single nucleotide polymorphisms, genotyping and end-point. All these types of assays use primers, probes, DNA polymerase and a master mix; however, all these components are in concentrations that are specific to the test being performed. In particular, the primers and probes used are specific to the target DNA of the test being performed.
Consideration was given to heading 8419 based on rulings such as N138137 (dated January 7, 2011) and N266682 (dated August 13, 2015). However, we have concluded that the CFX Opus Dx systems are integrated, fixed sample block instruments that can perform real-time PCR reaction. The CFX system under NY N138137 can only operate to perform a real-time PCR reaction when all the components are present. Additionally, the CFX Opus 96 Dx and CFX Opus 384 Dx instruments utilize a fixed sample block system with one serial number. The systems in N138137 have a thermal cycler serial number and an optical reaction module serial number or a reaction module serial number.
As described above, the CFX Opus Dx instruments have an integrated optical system that allows them to measure the fluorescence of probes labeled with a fluorophore. A conventional PCR instrument, like the model in ruling N138137, does not have an optical system; therefore, it cannot take fluorescence readings of probes labeled with fluorophores. This additional integrated feature makes it a composite good capable of both functions. Additionally, the combination of both functions makes the CFX Opus Dx instruments substantially more costly than a typical PCR machine that can only provide thermal cycling.
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings and any relevant section or chapter notes. In the event the articles cannot be classified solely on the basis of GRI 1, GRIs 2 through 6 may be applied in order, as appropriate. The Explanatory Notes to the HTSUS, while not legally binding, may also be consulted to aid in classification. The CFX Opus 96 Dx and CFX Opus 384 Dx qPCRs are considered to be composite goods within the meaning of GRI 3. Goods classifiable under GRI 3(b) shall be classified as if they consisted of the material or a component which gives them their essential character. The Explanatory Note to GRI 3(b)(VIII), states that the factors which determine essential character will vary between different kinds of goods. It may for example, be determined by the nature of the materials or components, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods. GRI 3(c) states that when the essential character of a composite good cannot be determined, classification is based on the heading that occurs last in numerical order among those which equally merit consideration. Inasmuch as no one component imparts the essential character to the subject composite items, GRI 3(b) does not apply. It is the opinion of this office that the thermal cycler of heading 8419, HTSUS, merits equal consideration to the fluorescence detection in heading 9027, HTSUS. Therefore, classification will be determined based on the competing heading that occurs last in numerical order. GRI 3(c) noted.
Accordingly, as suggested in your letter, the applicable subheading for the CFX Opus 96 Dx and CFX Opus 384 Dx qPCRs will be 9027.50.4060, 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: Other.” 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/current.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division