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August 2, 2021

Sang Joon Han

Associate Principal Scientist, Division of R&D

Access Bio, Inc.

65 Clyde Road, Suite A,

Somerset, NJ 08873

Device: CareStart COVID-19 Antigen Home Test

EUA Number: EUA210314

Company: Access Bio, Inc.

Indication: Qualitative detection of SARS-CoV-2 nucleocapsid protein

antigens from individuals with or without symptoms or other

epidemiological reasons to suspect a COVID-19 infection when

tested twice over two or three days with at least 24 hours and not

more than 48 hours between tests. This test is authorized for non-

prescription home use with self-collected direct anterior nasal

(nares) swab samples from individuals aged 14 years or older or

adult collected anterior nasal swab samples from individuals aged

2 years or older.

Dear Sang Joon Han:

This letter is in response to your

request that the Food and Drug Administration (FDA) issue

an Emergency Use Authorization (EUA) for emergency use of your product,

pursuant to

Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the

Department of Health and Human Services (HHS) determined that there is a public health

emergency that has a significant potential to affect national security or the health and security of

United States citizens living abroad, and that involves the virus that causes COVID-19.

Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of

HHS then declared that circumstances exist justifying the authorization of emergency use of in

vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the

terms of any authorization issued under Section 564(a) of the Act.

For ease of reference, this letter will use the term “you” and related terms to refer to Access Bio, Inc.

For ease of reference, this letter will use the term “your product” to refer to the CareStart COVID-19 Antigen

Home Test, that will also be offered under the authorized distributor brand name of “on/go COVID-19 Antigen Self-

Test”, used for the indication identified above.

U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration

that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020).

Summary of content (9 pages)

PAGE 1
August 2, 2021 Sang Joon Han Associate Principal Scientist, Division of R&D Access Bio, Inc. 65 Clyde Road, Suite A, Somerset, NJ 08873 Device: CareStart COVID-19 Antigen Home Test EUA Number: EUA210314 Company: Access Bio, Inc.
PAGE 2
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.
PAGE 3
Page 3 – Sang Joon Han, Access Bio, Inc. other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with your product should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be treated as presumptive, and confirmation with a molecular assay for patient management, may be performed if necessary.
PAGE 4
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.
PAGE 5
Page 5 – Sang Joon Han, Access Bio, Inc. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that your product (as described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.
PAGE 6
Page 6 – Sang Joon Han, Access Bio, Inc. established performance characteristics of which you and authorized distributor(s) become aware. D. You and authorized distributor(s) must inform relevant public health authorities of this EUA, including the terms and conditions herein, and any updates made to your product and/or the authorized labeling. E. Through a process of inventory control, you and authorized distributor(s) must maintain records of the locations (e.g., pharmacies, doctor’s offices, etc.
PAGE 7
Page 7 – Sang Joon Han, Access Bio, Inc. L. You may request changes to this EUA for your product, including to the Scope of Authorization (Section II in this letter) or to the authorized labeling, including requests to make available additional authorized labeling specific to an authorized distributor. Such additional labeling may use another name for the product but otherwise must be consistent with the authorized labeling, and shall not exceed the terms of authorization of this letter.
PAGE 8
Page 8 – Sang Joon Han, Access Bio, Inc. S. You must evaluate the usability of the “CareStart COVID-19 Antigen Home Test User Instructions” with individuals using only the paper instructions of your product in an FDA agreed upon post authorization study within 2 months of the date of this letter (unless otherwise agreed to with DMD/OHT7-OIR/OPEQ/CDRH). After submission to and concurrence with the data by FDA, you must update the authorized labeling, as applicable, to reflect the additional testing.
PAGE 9
Page 9 – Sang Joon Han, Access Bio, Inc. • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, • This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.