CLA-2-90:OT:RR:NC:N1:105
William Benedict
PTS Diagnostics
4600 Anson Boulevard
Whitestown, IN 46075
RE: The tariff classification of blood testing meter systems from Malaysia
Dear Mr. Benedict:
In your letter dated May 2, 2025, you requested a tariff classification ruling. Descriptive literature was
provided for our review.
The items under consideration are the AlCNow+ and the AlCNow Self Check HbAlc blood testing meter
systems, which are systems intended to quantitatively measure the percentage of glycated hemoglobin in
fresh capillary blood samples from the fingertip. The primary difference between the AlCNow+ and the
AlCNow Self Check is that the AlCNow+ is typically used in professional settings and has a larger number
of test cartridges included in the kit (quantity of ten or twenty depending on the set) versus the AlCNow Self
Check (quantity of four). The meters operate by performing a chemical and optical analysis of the blood. The
A1CNow+ measures 8.62 inches by 4 inches by 6.47 inches and weighs 489 grams. The A1CNow Self
Check measures 7.25 inches by 4.25 inches by 3.44 inches and weighs 174 grams.
To perform the test, a person using the lancet device deploys the lancet by pricking their finger to draw blood
before touching the capillary edge of the blood collector with the blood drop. The user then inserts the blood
collector into the shaker body. The user then shakes the shaker body vigorously for approximately 5 seconds
before standing the shaker on a table. The meter test cartridge is then prepared for use. The user then opens
the test cartridge packet and inserts it into the meter, checking to ensure that the identification code on the
cartridge matches the code on the body of the meter. The meter self-activates upon the insertion of the
cartridge and will display a “WAIT” message on the LCD screen. Once it is ready for the sample, the meter
will read “SMPL” on the screen. At this time, the user removes the shaker’s protective base and pushes the
shaker into a circular opening on the cartridge which dispenses the diluted sample into the cartridge. The
meter then runs the test, which takes five minutes to provide a result. If the test has run properly, the meter
will display a “QCOK” message, followed by the user's AlC level, and an indication of the number of tests
left on the meter.
The user is able to track their AlC levels over the course of several months to assist the user in monitoring
and managing their diabetes. These meter kits are designed, marketed, and sold for individual patient use,
either by the patient or medical professional, and are not for use in the diagnosis or screening of diabetes
mellitus. Unlike daily blood glucose meters, A1C tests give a measure of the average blood glucose over the
previous 2-3 months. Therefore, daily A1C testing is not necessary for over the counter customers. A1C
Now+ systems are often used daily by professionals in monitoring patients for diabetes during clinical visits.
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 goods consist 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., A1C testing). Finally, the articles are put up in a manner
suitable for sale directly to users without repacking. Therefore, the goods in question are 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 the opinion of this office that the essential character of both versions
is imparted by the A1C meter.
In your letter, you suggest classification of the AlCNow+ and the AlCNow Self Check HbAlc blood testing
meter systems under subheading 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.” We disagree. While the
systems will be classified within heading 9027, HTSUS, the devices utilize an optical element along with the
chemical element to perform the analysis. You state that the A1CNow analyzers utilize both immunoassay
and chemistry technology to measure the A1C total hemoglobin, respectively. In operation, upon the addition
of a diluted blood sample, blue microparticles conjugated to anti-A1C antibodies migrate along the reagent
strip. The amount of blue microparticles captured on the strips reflect the amount of A1C in this sample. The
optical component measures the amount of these blue microparticles. Since the analyzers utilize an optical
component, subheading 9027.89, HTSUS, would not apply.
Accordingly, the applicable subheading for the AlCNow+ and the AlCNow Self Check HbAlc blood testing
meter systems is 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 AlCNow+ and
the AlCNow Self Check HbAlc blood testing meter systems 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.” We note that in Headquarters Ruling (HQ) 56120 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. 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. In New York Ruling N292225 dated December 18, 2017, CBP held that
Insulet’s Insulin Delivery Omnipod was classified under 9817.00.96 for secondary classification purposes.
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).”
The AlCNow+ and the AlCNow Self Check HbAlc blood testing meter systems perform a chemical analysis
on a diabetic’s blood sample to determine if their levels are too high or too low, which is a direct link to the
physical impairment. In our view, the AlCNow+ and the AlCNow Self Check HbAlc blood testing meter
systems 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 AlCNow+ and the AlCNow Self Check
HbAlc blood testing meter systems 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,
Steven A. Mack
Director
National Commodity Specialist Division