CLA-2-90:OT:RR:NC:N3135
Michele Lehat
Grunfeld Desiderio Lebowitz Silverman & Klestadt LLP
599 Lexington Ave FL 36
New York, NY 10022
RE: The tariff classification of Virta GK System and its components from China
Dear Ms. Lehat:
In your letter dated May 20, 2025, you requested a tariff classification ruling on behalf of Keto-Check, Inc. A
sample was received and will be returned.
Virta GK System is a battery-operated dual blood glucose and ketone monitoring system. The system is said
to be comprised of one Virta GK Meter, ten Virta glucose test strips, ten Virta ketone test strips, one Virta
blood glucose control solution, one Virta blood ketone control solution, one Virta lancing device, twenty
sterile lancets, a user manual, package inserts, a quick reference guide, a warranty card, batteries, and a
carrying case. The sample only includes one GK Meter with batteries, one Virta lancing device, a vial of
glucose control solution level 2, a vial of ketone control solution level 2, a carrying case, a user manual, a
quick reference guide, and package inserts.
Glucose and ketone measurement are performed using an amperometric detection method. The test is based
on the measurement of an electrical current generated by the reaction between glucose in the blood sample
and reagents located on the electrode of the test strip. When a blood sample is applied, it is drawn into the tip
of the test strip by capillary action. The glucose present in the sample reacts with a glucose or ketone-specific
enzyme and mediator, generating electrons and producing a current. The strength of the electrical current is
positively correlated with the glucose concentration in the sample. Following the reaction period, the glucose
or ketone concentration is displayed on the device. The Virta GK System can also transmit real-time data to
the patient’s clinical care team.
To use the Virta GK System, the user employs the lancing device to prick the fingertip and produce a drop of
blood. The blood is then applied to a ketone or glucose test strip inserted into the meter. Once the
amperometric signal is measured, the meter calculates and displays the corresponding glucose or ketone
concentration. The Virta GK System is intended for the quantitative measurement of glucose or ketone
concentrations in fresh capillary whole blood samples obtained from the fingertips.
The Virta GK Meter is a battery-powered device designed to deliver glucose and ketone measurements to the
intended user. The meter is intended for use with compatible test strips, lancets, and control solutions. The
device provides real-time blood glucose or ketone readings to the user via the LED display on the front of the
meter or can transmit real-time data to the patient’s clinical team using the equipped Bluetooth functionality.
The Virta lancing device is a pen-like device. It consists of a cap having a dial with five depth settings, a
connecting collar, a lancet holder, a lancet ejector, a reset handle (spring loader), a release button, and a
plastic housing. The lancet is a sterile, single-use device. Based on online research, it is a metal needle like
article encased in a plastic holder with a plastic cap. The lancet will be inserted in the lancing device and
when activated, the lancing device propels the lancet into the skin to obtain a blood sample for testing.
The bi-fold case (carrying case) is constructed with an outer surface of textile. You have indicated in your
letter that it is composed of polypropylene fiber, which is considered a man-made fiber in this form. The case
has a zipper around three sides, and two interior mesh pockets.
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 good 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 good 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 Virta
GK Meter.
Accordingly, as you suggest in your letter, the applicable subheading for the complete Virta GK System will
be 9027.89.4530, 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: Electrical:
Chemical analysis instruments and apparatus.” The general rate of duty will be free.
The applicable subheading for the Virta GK Meter when imported separately will be 9027.89.4530, 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: Electrical: Chemical analysis instruments and
apparatus.” The general rate of duty will be free.
The applicable subheading for the lancets when imported separately will be 9018.39.0050, HTSUS, which
provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including
scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories
thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other: Other.” The
general rate of duty will be free.
The applicable subheading for the Virta lancing Device when imported separately will be 9018.90.8000,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments and appliances
used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: Other instruments
and appliances and parts and accessories thereof: Other: Other.” The general rate of duty will be free.
The applicable subheading for the carrying case when imported separately will be 4202.92.9100, HTSUS,
which provides for other containers and cases, with outer surface of sheeting of plastic or of textile materials,
other, other, with outer surface of textile materials, of man-made fibers (except jewelry boxes of a kind
normally sold at retail with their contents). The general rate of duty will be 17.6 percent ad valorem.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“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 one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314.
The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be
“specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons
to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs
and Border Protection (CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection
(CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of
U.S. Note 4(a) to Chapter 98 of the HTSUS. Additionally, as discussed in HQ 964169 (dated June 26, 2001),
“people with diabetes are limited in their ability to perform a broad range of jobs because they must be able
to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive
urination, possible nausea, dizziness and fainting. This interferes with working, a major life activity.
Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially
limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note
4(a).”
In HQ 562869 (dated December 23, 2003), CBP held that a pump designed for individuals suffering from
diabetes or glucose control problems was an article specifically designed or adapted for the handicapped and
is properly classified under 9817.00.96 for secondary classification purposes. CBP has previously ruled that
glucose monitoring systems (NY ruling N341988, dated August 15, 2024), diabetic pen needles and lancets
(HQ H110795, dated August 5, 2011), a lancing device and lancets (NY ruling N348999 dated June 11, 2025
), and carrying cases specifically designed to hold and carry blood glucose meters (HQ 563264, dated May 6,
2005), qualified for duty-free treatment under subheading 9817.00.96, HTSUS.
The Virta GK System is specifically designed for use by diabetic persons in a home setting to perform a
chemical analysis on a blood sample to determine if their levels are too high or too low. Based on the
information provided and the precedents, it is the opinion of this office that the Virta GK System is
specifically designed for use by the handicapped. Therefore, we agree that secondary classification
9817.00.96, HTSUS, would apply to the Virta GK System and the Virta GK Meter, Virta lancing Device,
lancets, and carrying case when imported separately and will be free of duty and the Merchandise Processing
Fee (MPF) upon importation into the United States.
The classification of the Virta blood glucose solution and ketone control solution will be addressed under
separate correspondence. Your inquiry does not provide enough information for us to give a classification
ruling on the glucose strips and ketone strips. Your request for a classification ruling should include the
following information: provide a complete chemical breakdown by percent by weight of each strip totaling
100 percent, state the use and function of each ingredient, and provide an exploded view diagram of each
strip identifying each component. When this information is available, you may consider resubmission of your
request. If you decide to resubmit your request, please include all of the material that we have returned to
you.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 heading 9027, please
National Import Specialist (NIS) Jason Christie at [email protected]. If you have any questions
regarding heading 9018, please contact NIS Fei Chen at [email protected]. If you have any questions
regarding heading 4202, please contact NIS Vikki Lazaro at [email protected].
Sincerely,
(for)
Steven A. Mack
Director
National Commodity Specialist Division