April 13, 2021

Bryan Bothwell
Qorvo Biotechnologies, LLC.
14502 21st Avenue, #212
Plymouth, MN 55447

Device: Omnia SARS-CoV-2 Antigen Test

EUA Number: EUA203121
Company: Qorvo Biotechnologies, LLC.
Indication: Qualitative detection of nucleocapsid viral antigens from SARS-
CoV-2 in direct anterior nasal (NS) swab specimens without
transport media from individuals who are suspected of COVID-19
by their healthcare provider within the first six days of symptom
onset. Emergency use of this test is limited to authorized
laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the
requirements to perform moderate or high complexity tests.

Dear Mr. Bothwell:

This letter is in response to your 1 request that the Food and Drug Administration (FDA) issue an
Emergency Use Authorization (EUA) for emergency use of your product, 2 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

1
For ease of reference, this letter will use the term “you” and related terms to refer to Qorvo Biotechnologies, LLC.,
a wholly owned subsidiary of Qorvo US, Inc.
2
For ease of reference, this letter will use the term “your product” to refer to the Omnia SARS-CoV-2 Antigen Test.
Page 2 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

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. 3

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 “Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test
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 an integrated system of instrument and reagent cartridges using immunoassay
principles for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in direct
anterior nasal (NS) swab specimens without transport media from individuals who are suspected
of COVID-19 by their healthcare provider within the first six days of symptom onset. Your
product does not differentiate between SARS-CoV and SARS-CoV-2. The SARS-CoV-2
nucleocapsid protein antigen is generally detectable in direct NS specimens during the acute
phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation
3
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).
4
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Page 3 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

with patient history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses. Negative
results should be treated as presumptive and confirmation with a molecular assay, if necessary,
for patient management may be performed. Negative results do not rule out SARS-CoV-2
infection and should not be used as the sole basis for treatment or patient management decisions,
including infection control decisions. Negative results should be considered in the context of a
patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent
with COVID-19.

Testing of NS specimens using your product, as outlined in the “Qorvo Biotechnologies Omnia
SARS-CoV-2 Antigen Test Instructions for Use” is limited to laboratories certified under CLIA
that meet the requirements to perform moderate or high complexity tests.

To use your product, which is an automated Bulk Acoustic Wave (BAW) biosensor-based test, a
direct NS specimen collected from the patient is first processed using a lysis buffer to disrupt the
virus and expose the internal viral nucleocapsid protein. The processed specimen is added to the
cartridge and the cartridge is inserted into the Qorvo Omnia instrument. The instrument is
provided with and used according to the “Operator Manual: Qorvo Biotechnologies Omnia
System Operator Manual”, and “Quick-Start Guide: Qorvo Biotechnologies Omnia System
Quick-Start Guide.” The instrument moves fluid from the sample port and various reagents from
the cartridge carousel across the biosensor contained within the cartridge. On the surface of the
biosensor an enzyme-enhanced immune reaction takes place: antibodies to SARS-CoV-2
nucleocapsid protein on the resonator surface capture the specific antigens to SARS-CoV-2. An
enzyme-conjugated anti-nucleocapsid antibody binds to the immobilized SARS-CoV-2 antigens.
The reaction causes a change in resonance frequency which is detected by the instrument.
Results are then reported in Arbitrary Units/mL (AU/mL) and designated as “positive” or
“negative” based on a set cut-off value.

The Omnia SARS-CoV-2 Antigen Test includes the following materials or other authorized
materials: cartridges, vials of lysis buffer, dropper caps, and nasal swabs.

You require use of the External Positive Control (required but not provided with your product),
or other authorized controls (as may be requested under Condition O. below), that are run as
outlined in the “Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test Instructions for Use”:

• External Positive Control – Qorvo Biotechnologies Omnia SARS-CoV-2 External

Control, includes Positive control vials

Your product also requires the use of additional authorized materials and authorized ancillary
reagents that are not included with your product and are described in the Instructions for Use.

The labeling entitled “Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test Instructions for
Use”, “Instructions for Use: Qorvo Biotechnologies Omnia SARS-CoV-2 External Control”,
“Quick-Start Guide: Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test”, “Operator
Manual: Qorvo Biotechnologies Omnia System Operator Manual”, and “Quick-Start Guide:
Qorvo Biotechnologies Omnia System Quick-Start Guide” (available at
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
Page 4 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

authorizations-medical-devices/vitro-diagnostics-euas), 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”:

• Fact Sheet for Healthcare Providers: Qorvo Biotechnologies, LLC. - Omnia SARS-
CoV-2 Antigen Test
• Fact Sheet for Patients: Qorvo Biotechnologies, LLC. - Omnia SARS-CoV-2
Antigen Test

The above described product, when accompanied by the authorized labeling provided as set forth
in the Conditions of Authorization (Section IV), is authorized to be distributed to and used by
authorized laboratories 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.

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.

The emergency use of your product under this EUA must be consistent with, and may not
exceed, the terms of this letter, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) of
the Act described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1) of the Act, your product is authorized for the indication above.

III. Waiver of Certain Requirements

I am waiving the following requirements for your product during the duration of this EUA:

• Current good manufacturing practice requirements, including the quality system

requirements under 21 CFR Part 820 with respect to the design, manufacture,
packaging, labeling, storage, and distribution of your product, but excluding Subpart
H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I
(Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques,
21 CFR 820.250).
Page 5 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

IV. Conditions of Authorization

Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:

Qorvo Biotechnologies, LLC. (You) and Authorized Distributor(s) 5

A. Your product must comply with the following labeling requirements under FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
directions for use (21 CFR 809.10(b)(5), (7), and (8)); appropriate limitations on the use
of the device including information required under 21 CFR 809.10(a)(4); and any
available information regarding performance of the device, including requirements under
21 CFR 809.10(b)(12).

B. You and authorized distributor(s) must make your product available with the
authorized labeling to authorized laboratories.

C. You and authorized distributor(s) must make available on your website(s) the
authorized labeling.

D. You and authorized distributor(s) will include a physical copy of the

“Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test Instructions for Use,” and
“Quick-Start Guide: Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test” with
with each shipped product to authorized laboratories, and will make the “Qorvo
Biotechnologies Omnia SARS-CoV-2 Antigen Test Instructions for Use,” and “Quick-
Start Guide: Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test” electronically
available with the opportunity to request a copy in paper form, and after such request,
you must promptly provide the requested information without additional cost.

E. You and authorized distributor(s) must inform authorized laboratories and relevant
public health authorities of this EUA, including the terms and conditions herein, and
any updates made to your product and authorized labeling.

F. Through a process of inventory control, you and authorized distributor(s) must maintain
records of the authorized laboratories to which they distribute the test and number of tests
they distribute.

G. You and authorized distributor(s) must collect information on the performance of your
product. You will report to FDA any suspected occurrence of false positive or false
negative results and significant deviations from the established performance
characteristics of the product of which you become aware.

H. You and authorized distributor(s) are authorized to make available additional

5
“Authorized Distributor(s)” are identified by you, Qorvo Biotechnologies, LLC., in your EUA submission as an
entity allowed to distribute your product.
Page 6 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

information relating to the emergency use of your product that is consistent with, and
does not exceed, the terms of this letter of authorization.

I. You and authorized distributor(s) will make available the SARS-CoV-2 specific
reagents External Positive Control – Qorvo Biotechnologies Omnia SARS-CoV-2
External Control with the “Instructions for Use: Qorvo Biotechnologies Omnia SARS-
CoV-2 External Control,” or other authorized materials or control materials (as may be
requested under Condition O. below), at the same time as your product.

Qorvo Biotechnologies, LLC. (You)

J. You must notify FDA of any authorized distributor(s) of your product, including the
name, address, and phone number of any authorized distributor(s).

K. You must provide authorized distributor(s) with a copy of this EUA and communicate to
authorized distributor(s) any subsequent revisions that might be made to this EUA and its
authorized accompanying materials (e.g., Fact Sheets).

L. You must comply with the following requirements pursuant to FDA regulations: Subpart
H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I
(Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21
CFR 820.250).

M. You must have lot release procedures and the lot release procedures, including the study
design and statistical power, must ensure that the tests released for distribution have the
clinical and analytical performance claimed in the authorized labeling.

N. If requested by FDA, you must submit lot release procedures to FDA, including sampling
protocols, testing protocols, and acceptance criteria, that you use to release lots of your
product for distribution in the U.S. If such lot release procedures are requested by FDA,
you must provide it within 48 hours of the request.

O. 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. Any request for changes to this EUA should be submitted to the Division of
Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In Vitro
Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and Quality
(OPEQ)/Center for Devices and Radiological Health (CDRH) and require appropriate
authorization from FDA prior to implementation.

P. You must evaluate the analytical limit of detection and assess traceability 6 of your

6
Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
Page 7 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

product with any FDA-recommended reference material(s). After submission to and

review and concurrence with the data by FDA, you must update labeling to reflect the
additional testing. Such labeling updates must be made in consultation with, and
require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

Q. You must complete the agreed upon real-time stability study for your product and notify
DMD/OHT7-OIR/OPEQ/CDRH of the testing results as they become available until
completion of the study. After submission of the study data, and review and concurrence
with the data by FDA, you must update your product labeling to reflect the additional
testing. Such labeling updates must be made in consultation with, and require
concurrence of, DMD/OHT7- OIR/OPEQ/CDRH.

R. You must complete the agreed upon software validation of your product in an FDA
agreed upon post authorization study within 4 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 make any necessary updates to the
authorized labeling to reflect the additional testing. Such labeling updates will be made
in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

S. You must have a process in place to track adverse events, including any occurrence of
false results and report to FDA pursuant to 21 CFR Part 803.

Authorized Laboratories

T. Authorized laboratories using your product must include with test result reports, all
authorized Fact Sheets. Under exigent circumstances, other appropriate methods for
disseminating this labeling may be used, which may include mass media.

U. Authorized laboratories using your product must use your product as outlined in the
authorized labeling. Deviations from the authorized procedures, including authorized
instruments, authorized clinical specimen types, authorized control materials, authorized
ancillary reagents and authorized materials required to use your product are not
permitted.

V. Authorized laboratories that receive your product must notify the relevant public health
authorities of their intent to run your product prior to initiating testing.

W. Authorized laboratories using your product must have a process in place for reporting test
results to healthcare providers and relevant public health authorities, as appropriate.

X. Authorized laboratories must collect information on the performance of your product and
report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-
Reporting@fda.hhs.gov) and you (https://www.qorvo.com/go/biotech) any suspected
occurrence of false positive or false negative results and significant deviations from the
established performance characteristics of your product of which they become aware.
Page 8 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

Y. All operators using your product must be appropriately trained in performing and
interpreting the results of your product, use appropriate personal protective equipment
when handling this kit, and use your product in accordance with the authorized labeling.

Qorvo Biotechnologies, LLC. (You), Authorized Distributor(s) and Authorized

Laboratories

Z. You, authorized distributor(s), and authorized laboratories using your product must
ensure that any records associated with this EUA are maintained until otherwise notified
by FDA. Such records will be made available to FDA for inspection upon request.

Conditions Related to Printed Materials, Advertising and Promotion

AA. All descriptive printed matter, advertising, and promotional materials relating to
the use of your product shall be consistent with the authorized labeling, as well as the
terms set forth in this EUA and meet the requirements set forth in section 502(a), (q)(1),
and (r) of the Act and FDA implementing regulations.

BB. No descriptive printed matter, advertising, or promotional materials relating

to the use of your product may represent or suggest that this test is safe or effective
for the detection of SARS-CoV-2.

CC. All descriptive printed matter, advertising, and promotional materials

relating to the use of your product shall clearly and conspicuously state that:

• This product has not been FDA cleared or approved, but has been authorized by
FDA under an EUA for use by authorized laboratories;

• This product has been authorized only for the detection of proteins from
SARS-CoV-2, not for any other viruses or pathogens; and,

• 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 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.

The emergency use of your product as described in this letter of authorization must
comply with the conditions and all other terms of this authorization.

V. Duration of Authorization

This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of
Page 9 – Bryan Bothwell, Qorvo Biotechnologies, LLC.

COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.

Sincerely,

____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration

Enclosure