User Manual

Table Of Contents

RCPM-00279, RCPM-00479, RCPM-02079

Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen

on/go

COVID-19 Antigen Self-Test

IFU-RCPM79-E / Rev. A

ACCESS BIO, INC.

Page 4 of 16

barcode is not valid for any reason, the user is presented with a final screen indicating

the fail reason by one of the below:

Invalid: Barcode Not Found

Invalid: Test Expired

Invalid: Test Barcode Invalid

Invalid: Test Previously Used

Reagents and Materials

Materials provided

All following required components for single-use are packed and sealed in a tray.

• a test device: foil pouched test device containing one test strip which is encased in

plastic device cassette with a desiccant.

• an extraction vial and cap: the extraction vial contains 500 µL of extraction buffer

solution.

• a nasal swab: swab for anterior nasal specimen collection.

Quick Reference Instructions and Individual Fact Sheet are also included in each box.

on/go™ COVID-19 Antigen Self-Test is available in the following packaging configuration: 2

tests (REF: RCPM-00271), 4 tests(REF: RCPM-00471), or 20 tests (REF: RCPM-02071)

Materials required but not provided

• Smartphone (supplied by the user): iOS13 or newer for Apple iPhone

Android10 or newer for Android Phone

• Mobile application: Prior to testing, the user should download the free mobile

application, on/go™ App, for iOS or Android smartphones.

• Timer

Warnings and Precautions

 For in vitro diagnostic use only.

 This product has not been FDA cleared or approved but has been authorized by FDA under

an Emergency Use Authorization (EUA).

 This product has been authorized only for the detection of proteins from SARS-CoV-2, not

for any other viruses or pathogens.

 The emergency use of 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

the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food,

Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated,

or authorization is revoked sooner.