CLA-2-90:OT:RR:NC:N1:105
Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW, Suite 300
Washington, DC 07430
RE: The tariff classification of blood monitoring meters from South Korea
Dear Mr. Finkelstein:
In your letter dated June 11, 2025, on behalf of your client, Coagusense, Inc., you requested a tariff
classification ruling. Descriptive literature was provided for our review.
The first three items under consideration are described as high-accuracy prothrombin time/international
normalized ratio (PT/INR) test meters (model numbers PT2 PT/INR Monitoring Meter PST, PT2 PT/INR
Monitoring Meter Pro, and PT3 PT/INR Monitoring Meter PST). The devices are primarily designed for
home and laboratory use, allowing patients with chronic cardiovascular or thromboembolic conditions
requiring anticoagulant therapy to monitor their PT/INR levels. The PT/INR meters are available by
prescription only and designed for persons with particular diagnoses, including unspecified, chronic,
paroxysmal, or persistent atrial fibrillation, acute deep vein embolism and thrombosis, coagulation defects,
presence of a prosthetic heart valve, and other conditions which require the long-term use of anticoagulant
medications.
The meters are all very similar with only a few defining characteristics. The PT2 PRO (Professional) meter is
intended for use by healthcare professionals in various settings such as hospitals, doctor’s offices, and
laboratories. The PT2 PST (Patient Self Testing) and PT3 PST meters are intended for use by the patient
directly. After testing, the patient provides the test results to their healthcare provider, who in turn uses the
test results to manage the patient’s anticoagulation medication. The PT2 PRO and PT2 PST models operate
under the same platform and technology. The user interface differs depending on whether it is intended for
use by professionals (PRO) or for patient self-testing (PST). The PT2 and PT3 meters are distinguished by
their functionality and user interface. The PT2 meter can transfer testing data using Bluetooth, Wi-Fi, or a
wired connection, while the PT3 meter can transfer data by Bluetooth only. In addition, the PT2 meter
displays prompts using words with explanations, while the PT3 meter uses an icon-based display resembling
apps on a smartphone. The devices are imported with the user manual, quick reference guide, and power
supply. The meters feature a user-friendly color touchscreen with displayed instructions to guide users
through the testing process.
The fourth item under consideration is the PT/INR Professional Monitoring Meter Kit (Assure PT Care),
which is a device that operates similarly to the PT2 PT/INR Monitoring Meter Pro but also includes
additional components. The kit is imported with the meter, user manual, quick reference guide, testing tips
guide, power supply, a sample pack of lancets, sample transfer tubes, a stylus pen, and a carrying case.
The PT/INR meters function by measuring the clotting time of a fresh capillary whole blood sample applied
to a test strip, which is read by the meter to electronically measure the time it takes for blood to clot. The user
inserts into the PT/INR meter a single-use test strip which contains thromboplastin, a reagent that triggers the
natural process by which blood begins to clot. The system utilizes a small blood sample obtained using a
lancing device, applied using a transfer tube to the single-use test strip inserted into the PT/INR. The PT/INR
meter, using a micro electromechanical sensor strip, detects the physical formation of the clot and provides a
quantitative measurement of PT/INR based on the length of time the clot takes to form. A small, rotating
wheel with spokes mixes the blood sample with the reagent, and as the blood clots, it is drawn into the light
path of an infrared beam, interrupting the beam. The time it takes for the clot to interrupt the light beam is
recorded as the Prothrombin Time (PT) in seconds.
A high INR reading means that blood is taking longer than normal to clot, which can increase the risk of
bleeding, while a low INR reading indicates that blood is clotting too quickly, increasing the risk of blood
clots. The reading from the PT/INR meter allows the user’s healthcare providers to measure the efficacy of
anticoagulant medications and adjust as needed.
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 PT/INR Professional
Monitoring Meter Kit 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
PT/INR Professional Monitoring Meter Kit 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 PT/INR meter.
In your letter, you suggest the classification of the aforementioned meters to be under subheading
9018.19.5500, HTSUS, as patient monitoring systems. We disagree. The devices are not used to monitor vital
signs and physiological parameters of a patient. Instead, it measures the clotting time of a whole blood
sample on a test strip in various settings including home and laboratories. In our opinion, the device functions
similar to the blood glucose monitoring system in NY ruling N027180, dated May 7, 2008.
The applicable subheading for the PT/INR monitoring meters (model numbers PT2 PT/INR Monitoring
Meter PST, PT2 PT/INR Monitoring Meter Pro, and PT3 PT/INR Monitoring Meter PST) as well as the
complete PT/INR monitoring meter kits 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.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries
will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading
9027.50.4015, HTSUS, listed above.
In your letter, you also requested consideration of a secondary classification for the subject PT/INR
monitoring meters under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically
designed or adapted for the use or benefit of the permanently or chronically physically or mentally
handicapped. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other
physically or mentally handicapped persons as including “any person suffering from a permanent or chronic
physical or mental impairment which substantially limits one or more major life activities, such as caring for
oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.”
The complete PT/INR monitoring meter kits and the PT/INR monitoring meters (model numbers PT2
PT/INR Monitoring Meter PST, PT2 PT/INR Monitoring Meter Pro, and PT3 PT/INR Monitoring Meter
PST) perform a chemical analysis on blood samples to determine if their INR levels are too high or too low,
which is a direct link to the physical impairments listed above.
In our view, the complete PT/INR monitoring meter kits and the PT/INR monitoring meters (model numbers
PT2 PT/INR Monitoring Meter PST, PT2 PT/INR Monitoring Meter Pro, and PT3 PT/INR Monitoring Meter
PST) satisfy the description set forth in Chapter 98, Subchapter XVII, U.S. Note 4(a). Therefore, we agree
that secondary classification 9817.00.96, HTSUS, would apply to the PT/INR monitoring meters and kit and
will be free of duty and the Merchandise Processing Fee (MPF) upon importation into the United States. Note
that this classification has no effect on any quota, visa, or restricted merchandise requirements or
countervailing or dumping duties.
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. Please note that the additional duties imposed by heading
9903.01.25 do not apply to goods for which entry is properly claimed under a provision of chapter 98 of the
HTSUS, except for goods entered under headings 9802.00.40, 9802.00.50, 9802.00.60, and 9802.00.80. For
headings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the value of repairs,
alterations, or processing performed abroad, as described in the applicable heading. For heading 9802.00.80,
the additional duties apply to the value of the article less the cost or value of such products of the United
States, as described in heading 9802.00.80.
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 [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division