Product Datasheet/Brochure

Page 4 – Sang Joon Han, Access Bio, Inc.
strip forming an immune complex. The immune complex is then captured by the test line on the
nitrocellulose membrane as it migrates through the strip. Test results are interpreted visually after
10 minutes based on the presence or absence of visually detectable purple and blue colored lines.
Upon completion of the test and result interpretation the user should share their results with their
healthcare provider.
The CareStart COVID-19 Antigen Home Test kit includes the following materials or other
authorized materials packed and sealed in a tray: Test Device (pouched with desiccant),
extraction vial and cap, Nasal Swab, Quick Reference Instructions, and Fact Sheet for
Individuals.
Your product includes an internal control test line that must generate the expected result for a test
to be considered valid, as outlined in the “CareStart COVID-19 Antigen Home Test Healthcare
Provider Instructions for Use”.
The labeling entitled “CareStart COVID-19 Antigen Home Test Healthcare Provider
Instructions for Use”, the “CareStart COVID-19 Antigen Home Test User Instructions” (Quick
Reference Instructions) and the “CareStart COVID-19 Antigen Home Test” box labels
(available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas), the “on/go App”
software application, and the following fact sheets pertaining to the emergency use, is required to
be made available as set forth in the Conditions of Authorization (Section IV), and are
collectively referred to as “authorized labeling”
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:
• Fact Sheet for Healthcare Professionals: Access Bio, Inc. - CareStart COVID-19
Antigen Home Test
• Fact Sheet for Individuals: Access Bio, Inc. - CareStart COVID-19 Antigen Home
Test
The above described product, with the authorized labeling as set forth in the Conditions of
Authorization (Section IV) is authorized to be distributed and used under this EUA, despite the
fact that it does not meet certain requirements otherwise required by applicable federal law.
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of your product, when used consistent with the Scope of
Authorization of this letter (Section II), outweigh the known and potential risks of your product.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that your product may be effective in
diagnosing COVID-19, when used consistent with the Scope of Authorization of this letter
(Section II), pursuant to Section 564(c)(2)(A) of the Act.
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The “authorized labeling” listed in this paragraph (and elsewhere) specifically refers to the labeling for the
CareStart COVID-19 Antigen Home Test; however, “authorized labeling” under this letter also includes these
specific pieces of labeling when entitled with the authorized distributor brand name of “on/go COVID-19 Antigen
Self-Test,” as would be the case with other authorized distributor brand names added in accordance with Condition
L. below.