Product Datasheet/Brochure

Page 2 – Sang Joon Han, Access Bio, Inc.
FDA considered the totality of scientific information available in authorizing the emergency use
of your product for the indication above. A summary of the performance information FDA
relied upon is included in the “CareStart COVID-19 Antigen Home Test Healthcare Provider
Instructions for Use” identified below.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the Scope of
Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that your product may be effective in diagnosing COVID-19, and that the known and
potential benefits of your product when used for diagnosing COVID-19, outweigh the
known and potential risks of your product; and
3.
There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited to the indication above.
Authorized Product Details
Your product is a chromatographic, digital immunoassay intended for the qualitative detection of
nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or
other epidemiological reasons to suspect COVID-19 when tested twice over two or three days
with at least 24 hours and no more than 48 hours between tests. This test is interpreted by a
compatible smartphone. This test is authorized for non-prescription, home use with self-collected
(unobserved) direct anterior nasal swab specimens from individuals aged 14 years or older, or
with adult collected anterior nasal swab specimens from individuals aged 2 years or older.
The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in anterior nasal swabs
during the acute phase of infection. Positive results indicate the presence of viral antigens, but
clinical correlation with past medical history and other diagnostic information is necessary to
determine infection status. Positive results do not rule out bacterial infection or co-infection with
4
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.