Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is described as an immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML algorithms. The document explicitly states "Not Found (This is an immunochromatographic assay, not a machine learning device)" in the description of the training set.

Therapeutic

No
The device is an in vitro diagnostic test intended to detect influenza antigens, aiding in diagnosis, not to provide therapy or treatment.

Diagnostic

Yes

The device is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type A and type B nucleoprotein antigens, explicitly stated as intended "to aid in the rapid differential diagnosis of influenza A and B viral infections."

SaMD (Software as a Medical Device)

No

The device is an immunochromatographic assay, which is a physical test stick that detects antigens. It is a hardware-based diagnostic device, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the OSOM® ULTRA PLUS FLU A&B Test is an "in vitro rapid diagnostic immunochromatographic assay."
Function: The device is designed to detect influenza type A and type B nucleoprotein antigens in biological specimens (nasal and nasopharyngeal swabs) outside of the body (in vitro).
Purpose: It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections, which is a diagnostic purpose.

The description clearly aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses.

A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the US 2018-2019 influenza season when A/ H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation. When other influenza A or B viruses are emerging, performance characteristics may vary.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Product codes (comma separated list FDA assigned to the subject device)

PSZ

Device Description

The OSOM® ULTRA PLUS FLU A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line in the test line region indicates an A, B or A and B positive result. A visible control line with no test line is a negative result.

OSOM® ULTRA PLUS FLU A&B Test Kit contains the following components:

25 Test Sticks
25 Sterile Nasal Swabs
25 Extraction Buffer vials each containing: 0.25 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative)
1 Influenza A Positive Control Swab (packaged with a desiccant tablet): coated with non-infectious recombinant influenza A containing 0.05% sodium azide
1 Influenza B Positive Control Swab (packaged with a desiccant tablet): coated with non-infectious recombinant influenza B containing 0.05% sodium azide
1 Instructions for Use (IFU)
1 Quick Reference Guide (QRG)
1 Workstation

Note: (2 extra Test Sticks and Extraction Buffer vials have been included in the kit for External Quality Control Testing)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal and nasopharyngeal swab specimens

Indicated Patient Age Range

The clinical study included patients across the following age groups: ≤ 5 years, 6 to 21 years, 22 to 59 years, and ≥ 60 years.

Intended User / Care Setting

Clinical laboratory and point of care

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A prospective clinical study to establish the performance characteristics of the OSOM ULTRA PLUS FLU A&B Test in detecting influenza A and B antigens in nasal and nasopharyngeal swab specimens was conducted with specimens collected from January 2019 to May 2019 at 21 point-of-care (POC) sites across the United States. Testing was performed at POC sites representative of CLIA waived settings by untrained operators with no laboratory training or experience.

Samples were collected from individuals with influenza-like symptoms who provided informed consent. Two (2) nasal swabs or two (2) nasopharyngeal swabs were collected from the same nostril according to standard collection methods from each subject. One (1) nasal or nasopharyngeal swab was used for immediate testing with the OSOM ULTRA PLUS FLU A&B Test per the test procedure. The other nasal or nasopharyngeal swab of the pair was eluted in 3.0 mL of viral transport media (VTM). The sample eluted in VTM was stored at 2-8°C until transport was made on ice packs to a central reference laboratory. The samples collected in VTM were tested by the reference method, an FDA-cleared molecular test and another FDA-cleared molecular test for discrepant analysis, within the allowable time frames of specimen collection per the product instructions.

Nasal or nasopharyngeal swab specimens were collected from 1228 subjects enrolled in the prospective clinical study. Of those, 18 swab samples were unevaluable due to eligibility criteria. sample handling issues, or inconclusive testing results, leaving a total of 1210 prospective evaluable samples.

Due to the atypically low prevalence of influenza B virus in the U.S. during the 2018-2019 influenza season, 1210 prospective samples (20 influenza B positive samples and 1190 influenza B negative samples) were supplemented with 317 banked samples collected from previous influenza seasons, for a total of 1527 samples tested by untrained users at POC sites. Of those, one (1) banked sample was unevaluable due to sample handling issues, leaving a total of 316 evaluable banked samples. The banked samples were masked as subject samples, randomized, and incorporated into the daily workflow at three (3) CLIA waived sites that participated in the prospective clinical study.

A total of 1526 samples (1210 prospective samples and 316 banked samples) were included in the evaluation of the assay performance.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Study:

Study Type: Prospective clinical study
Sample Size: 1526 evaluable samples (1210 prospective, 316 banked)
Standalone Performance:
- Influenza A Performance - Nasal and Nasopharyngeal Swab Samples:
  - Sensitivity: 90.3% (95% CI: 87.0%-92.8%)
  - Specificity: 96.7% (95% CI: 95.5%-97.6%)
- Influenza B Performance - Nasal and Nasopharyngeal Swab Samples:
  - Sensitivity: 88.0% (95% CI: 81.8%-92.3%)
  - Specificity: 99.2% (95% CI: 98.6%-99.6%)
Key Results: The study demonstrated good sensitivity and specificity for both influenza A and B.

Reproducibility Studies:

Study Type: Multicenter reproducibility study
Sample Size: Operators tested coded, randomized, and masked swabs over five non-consecutive days. Specific total sample size for the reproducibility study itself is not explicitly stated in combined number, but each category shows results for 90 samples (30 per site x 3 sites).
Key Results: The OSOM ULTRA PLUS FLU A&B Test produces reproducible results when tested by multiple untrained intended users, at multiple sites, over multiple days. The study demonstrated that untrained intended users were able to accurately perform and interpret the OSOM ULTRA PLUS FLU A&B Test at and below the level of the LoD for both influenza A and influenza B.

Analytical Sensitivity: Limit of Detection (LoD):

Study Type: Dilution studies
Key Results:
- Influenza A/Michigan/45/15 (H1N1): 7.1x101 TCID50/mL
- Influenza A/Singapore/INFIMH-16-0019/2016 (H3N2): 2.2x105 CEID50/mL
- Influenza B/Colorado/6/2017 (Victoria): 3.5x103 TCID50/mL
- Influenza B/Phuket/3073/13 (Yamagata): 1.6x102 TCID50/mL

Analytical Reactivity:

Study Type: Testing with 28 influenza A, B, and C strains.
Key Results: All influenza A isolates gave expected A positive/B negative results. All influenza B isolates gave expected A negative/B positive results. Influenza C strain produced expected A negative/B negative results.

Analytical Specificity: Cross-Reactivity and Microbial Interference:

Study Type: Evaluation with 41 organisms (bacterial, viral, fungal) and human DNA.
Key Results: No cross-reactivity observed at tested concentrations.

Interfering Substances:

Study Type: Evaluation with potential interferents encountered in respiratory specimens.
Key Results: No interference observed with the test for any of the substances at the concentrations listed.

Competitive Interference:

Study Type: Evaluation with high levels of influenza A and influenza B.
Key Results: No competitive interference on test performance was observed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Influenza A Performance:
- Sensitivity: 90.3% (95% CI: 87.0%-92.8%)
- Specificity: 96.7% (95% CI: 95.5%-97.6%)
Influenza B Performance:
- Sensitivity: 88.0% (95% CI: 81.8%-92.3%)
- Specificity: 99.2% (95% CI: 98.6%-99.6%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Quidel Corp QuickVue® Influenza A+B Test (K180288)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 3, 2020

Sekisui Diagnostics, LLC Nisha Li Principal Regulatory Affairs Specialist 6659 Top Gun Street San Diego, California 92121

Re: K192719

Trade/Device Name: OSOM ULTRA PLUS FLU A&B Test Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test system Regulatory Class: Class II Product Code: PSZ Dated: September 24, 2019 Received: September 26, 2019

Dear Nisha Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Steven Gitterman, M.D., Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K192719

Device Name The OSOM® ULTRA PLUS FLU A&B Test

Indications for Use (Describe)

The OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses.

A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the US 2018-2019 influenza season when A/ H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation. When other influenza A or B viruses are emerging, performance characteristics may vary.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements 21 CFR 807.92.

The assigned 510(k) number is: K192719

1. Sponsor/Applicant Name and Address

Company Name:	Sekisui Diagnostics, LLC
Address:	6659 Top Gun Street
San Diego, CA 92121
Telephone:	858-777-2668
Contact Person:	Nisha Li, Principal Regulatory Affairs Specialist

Date Summary Prepared: 09/25/2019

2. Device Name and Classification

Trade Name:	OSOM® ULTRA PLUS FLU A&B Test
Regulation:	21 CFR 866.3328 – Influenza virus antigen detection test system
Classification of Device:	Class II
Product Code:	PSZ
Panel:	Microbiology (83)
Special Conditions for Use Statement:	For prescription use

3. Predicate Device

Quidel Corp QuickVue® Influenza A+B Test (K180288)

Device Description 4.

Operating Principle

The OSOM® ULTRA PLUS FLU A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple

4

line in the test line region indicates an A, B or A and B positive result. A visible control line with no test line is a negative result.

OSOM® ULTRA PLUS FLU A&B Test Kit Contents

OSOM ULTRA PLUS FLU A&B Test Kit contains the following components:

25 Test Sticks
25 Sterile Nasal Swabs
25 Extraction Buffer vials each containing: 0.25 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative)
1 Influenza A Positive Control Swab (packaged with a desiccant tablet): coated with non-infectious recombinant influenza A containing 0.05% sodium azide
1 Influenza B Positive Control Swab (packaged with a desiccant tablet): coated with non-infectious recombinant influenza B containing 0.05% sodium azide
1 Instructions for Use (IFU)
1 Quick Reference Guide (QRG)
1 Workstation

Note: (2 extra Test Sticks and Extraction Buffer vials have been included in the kit for External Quality Control Testing)

5. Indications for Use

The OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses.

A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the US 2018-2019 influenza season when A/H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation. When other influenza A or B viruses are emerging, performance characteristics may vary.

If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities,

5

specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Comparison to Predicate Device 6.

The following table provides a comparison of the characteristics of the OSOM® ULTRA PLUS FLU A&B Test to the predicate device, the Quidel® QuickVue Influenza A+B (K180288).

Similarities
Item	Predicate Device:
QuickVue® INFLUENZA A+B
Test K180288	Proposed 510(k) Device:
OSOM® ULTRA PLUS FLU
A&B Test
Indications for
Use	The QuickVue® Influenza A+B
Test allows for the rapid,
qualitative detection of influenza
type A and type B antigens
directly in nasal swab and
nasopharyngeal swab specimens
from symptomatic patients. The
test is intended for use as an aid
in the rapid differential diagnosis
of acute influenza type A and
type B viral infections. The test
is not intended to detect
influenza C antigens. A negative
test is presumptive, and it is
recommended these results be
confirmed by viral culture or an
FDA-cleared influenza A and B
molecular assay. Negative results
do not preclude influenza virus
infections and should not be used
as the sole basis for treatment or
other patient management
decisions. The test is intended
for professional and laboratory
use.

Performance characteristics for
influenza A were established
during the 2017/2018 influenza
seasons when influenza A/H3N2
and A/H1N1 pandemic were the
predominant influenza A viruses
in circulation. When other | The OSOM® ULTRA
PLUS FLU A&B Test is
an in vitro rapid
diagnostic
immunochromatographic
assay intended for the
qualitative detection of
influenza type A and type
B nucleoprotein antigens
directly from nasal and
nasopharyngeal swab
specimens from patients
with signs and symptoms
of respiratory infection.

It is intended to aid in the
rapid differential
diagnosis of influenza A
and B viral infections.
This test is not intended
for the detection of
influenza C viruses.

A negative test result is
presumptive, and it is
recommended these
results be confirmed by
viral culture or an FDA-
cleared influenza A and B
molecular assay. Negative
test results do not preclude
influenza virus infection
and should not be used as
the sole basis for |
| Similarities | | |
| Item | Predicate Device:
QuickVue® INFLUENZA A+B
Test K180288 | Proposed 510(k) Device:
OSOM® ULTRA PLUS FLU
A&B Test |
| | influenza A viruses are
emerging, performance
characteristics may vary. | treatment or other patient
management decisions. |
| | If infection with a novel
influenza A virus is suspected
based on current clinical and
epidemiological screening
criteria recommended by public
health authorities, specimens
should be collected with
appropriate infection control
precautions for novel virulent
Influenza viruses and sent to
state or local health department
for testing. Viral culture should
not be attempted in these cases
unless a BSL 3+ facility is
available to receive and culture
specimens. | Performance
characteristics for
influenza A were
established during the US
2018-2019 influenza
season when
A/H1N1pdm09 and
influenza A/H3N2 were
the predominant influenza
A viruses in circulation,
and the influenza B
Yamagata and Victoria
lineages were in co-
circulation. When other
influenza A or B viruses
are emerging,
performance
characteristics may vary.

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7

Performance Summary 7.

Expected Values

The prevalence of influenza varies year to year typically peaking in the winter months. The rate of positivity in influenza testing is impacted by many factors including specimen collection and handling, test method used, patient age, time of year, geographic location, and local disease prevalence.

8

The overall positivity rate as determined by the OSOM ULTRA PLUS FLU A&B Test during the 2018-2019 clinical study was 33.0% for influenza A and 1.7% for influenza B. The observed results by age are presented in the tables below.

| Age Group | Number of
Specimens | Number of Influenza A
Positives | Influenza A Positivity
Rate |
|----------------------|------------------------|------------------------------------|--------------------------------|
| ≤ 5 years of age | 362 | 127 | 35.1% |
| 6 to 21 years of age | 479 | 211 | 44.1% |
| ≥ 22 years of age | 369 | 61 | 16.5% |
| Total | 1210 | 399 | 33.0% |

Influenza A Positives by the OSOM ULTRA PLUS FLU A&B Test per Age Group

Influenza B Positives by the OSOM ULTRA PLUS FLU A&B Test per Age Group

| Age Group | Number of
Specimens | Number of Influenza B
Positives | Influenza B Positivity Rate |
|----------------------|------------------------|------------------------------------|-----------------------------|
| ≤ 5 years of age | 362 | 5 | 1.4% |
| 6 to 21 years of age | 479 | 9 | 1.9% |
| ≥ 22 years of age | 369 | 6 | 1.6% |
| Total | 1210 | 20 | 1.7% |

Clinical Performance

A prospective clinical study to establish the performance characteristics of the OSOM ULTRA PLUS FLU A&B Test in detecting influenza A and B antigens in nasal and nasopharyngeal swab specimens was conducted with specimens collected from January 2019 to May 2019 at 21 pointof-care (POC) sites across the United States. Testing was performed at POC sites representative of CLIA waived settings by untrained operators with no laboratory training or experience.

Samples were collected from individuals with influenza-like symptoms who provided informed consent. Two (2) nasal swabs or two (2) nasopharyngeal swabs were collected from the same nostril according to standard collection methods from each subject. One (1) nasal or nasopharyngeal swab was used for immediate testing with the OSOM ULTRA PLUS FLU A&B Test per the test procedure. The other nasal or nasopharyngeal swab of the pair was eluted in 3.0 mL of viral transport media (VTM). The sample eluted in VTM was stored at 2-8°C until transport was made on ice packs to a central reference laboratory. The samples collected in VTM were tested by the reference method, an FDA-cleared molecular test and another FDA-cleared molecular test for discrepant analysis, within the allowable time frames of specimen collection per the product instructions.

Nasal or nasopharyngeal swab specimens were collected from 1228 subjects enrolled in the prospective clinical study. Of those, 18 swab samples were unevaluable due to eligibility criteria. sample handling issues, or inconclusive testing results, leaving a total of 1210 prospective evaluable samples. The subject age and gender distribution for the 1210 prospective evaluable samples is presented in the table below.

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Age Group	Female	Male	Total
≤ 5 years	175	187	362
6 to 21 years	261	218	479
22 to 59 years	107	206	313
≥ 60 years	19	37	56
Total	562	648	1210

Age and Gender Distribution

Due to the atypically low prevalence of influenza B virus in the U.S. during the 2018-2019 influenza season, 1210 prospective samples (20 influenza B positive samples and 1190 influenza B negative samples) were supplemented with 317 banked samples collected from previous influenza seasons, for a total of 1527 samples tested by untrained users at POC sites. Of those, one (1) banked sample was unevaluable due to sample handling issues, leaving a total of 316 evaluable banked samples. The banked samples were masked as subject samples, randomized, and incorporated into the daily workflow at three (3) CLIA waived sites that participated in the prospective clinical study.

A total of 1526 samples (1210 prospective samples and 316 banked samples) were included in the evaluation of the assay performance. For a total of 1526 evaluable tests performed, one (1) was invalid (1/1526) for a 0.07% invalid rate (95%CI: 0.01%-0.37%). The performance of the OSOM ULTRA PLUS FLU A&B Test compared to an FDA-cleared molecular comparator method with prospective samples and banked samples is presented in the tables below.

| OSOM ULTRA PLUS FLU

A&B Test - Influenza A		Comparator Method
	Positive	Negative	Total
Positive	362	37 a	399
Negative	39 b	1088 c	1127
Total	401	1125	1526
Sensitivity	90.3% (95% CI: 87.0%-92.8%)
Specificity	96.7% (95% CI: 95.5%-97.6%)

Influenza A Performance - Nasal and Nasopharyngeal Swab Samples

ª Flu A was detected in 23/37 false positive specimens using a second FDA-cleared molecular test

b Flu A was not detected in 7/39 false negative specimens using a second FDA-cleared molecular test C All banked samples were negative for influenza A

[Two (2) samples did not yield valid results on the second FDA-cleared molecular test]

| OSOM ULTRA PLUS FLU

A&B Test - Influenza B	Comparator Method
	Positive	Negative	Total
Positive	132	11 a	143

Influenza B Performance - Nasal and Nasopharyngeal Swab Samples

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| OSOM ULTRA PLUS FLU

A&B Test - Influenza B	Comparator Method
	Positive	Negative	Total
Negative	18b	1365	1383
Total	150	1376	1526
Sensitivity	88.0% (95% CI: 81.8%-92.3%)
Specificity	99.2% (95% CI: 98.6%-99.6%)

a Nine (9) of the prospective samples and two (2) of the banked samples were false positive with the OSOM ULTRA PLUS FLU A&B Test. Flu B was detected in 3/11 false positive specimens using a second FDA-cleared molecular test.

b Four (4) of the prospective samples and 14 of the banked samples were negative by the OSOM ULTRA PLUS FLU A&B Test. Flu B was not detected in 2/18 false negative specimens using a second FDA-cleared molecular test.

Reproducibility Studies

Reproducibility of the OSOM ULTRA PLUS FLU A&B Test, when in the hands of untrained users, was evaluated in a multicenter study. Testing was performed at three (3) of the CLIA waived sites that participated in the prospective clinical study included samples with analyte levels at and below the limit of detection (LoD) for influenza A and influenza B.

A panel of swabs including true negative (no virus), high negative (just below the LoD), low positive (at or near the LoD) and moderate positive (at or near 2x the LoD) for influenza A and B were coded, randomized, and masked to the operators. Samples were masked as subject samples and were presented to the intended use operators for testing throughout the course of a normal testing day. The study was conducted with two operators per site over five non-consecutive days.

The OSOM ULTRA PLUS FLU A&B Test produces reproducible results when tested by multiple untrained intended users, at multiple sites, over multiple days. The study demonstrated that untrained intended users were able to accurately perform and interpret the OSOM ULTRA PLUS FLU A&B Test at and below the level of the LoD for both influenza A and influenza B. The results are presented in the table below.

Sample Category	Site 1	Site 2	Site 3	Overall
Influenza A High Negative1	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza A Low Positive	96.7% (29/30)	100% (30/30)	100% (30/30)	98.9% (89/90)
Influenza A Moderate Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza B High Negative1	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza B Low Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza B Moderate Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
True Negative	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)

Reproducibility Study Results - Percent Agreement with Expected Results

1 The "Expected Result" for High Negative samples is "not detected".

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Analytical Sensitivity: Limit of Detection

The limit of detection (LoD) for the OSOM ULTRA PLUS FLU A&B Test was established in dilution studies performed with 2 influenza A strains and 2 influenza B strains on two lots of the OSOM ULTRA PLUS FLU A&B Test. The LoD represents the concentration of influenza virus that produces consistently positive results > 95% of the time. The approximate LoD concentrations identified for each strain tested are listed in the table below.

| Influenza

Type	Viral Strain Tested	LoD
A	Influenza A/Michigan/45/15 (H1N1)	7.1x101 TCID50/mL
A	Influenza A/Singapore/INFIMH-16-0019/2016 (H3N2)	2.2x105 CEID50/mL
B	Influenza B/Colorado/6/2017 (Victoria)	3.5x103 TCID50/mL
B	Influenza B/Phuket/3073/13 (Yamagata)	1.6x102 TCID50/mL

Analytical Reactivity

A total of 28 influenza A, B, and C strains were tested with the OSOM ULTRA PLUS FLU A&B TEST A&B Test, at levels at or near the assay limit of detection (LoD). All influenza A isolates gave the expected influenza A positive and influenza B negative results, and all influenza B isolates gave the expected influenza A negative and influenza B positive results. The influenza strain isolates in the table below are listed at the lowest testing concentrations that gave the expected results. *NOTE: The influenza C strain listed below produced the expected influenza A negative and influenza B negative results and is listed at the highest concentration tested.

Influenza Strain	Concentration	Type	Sub Type	Test Result
A/NY/02/09	1.23x10¹ TCID50/mL	A	H1N1pdm	Detected
A/Mexico/4108/09	7.24x10¹ TCID50/mL	A	H1N1pdm	Detected
A/Singapore/63/04	1.57x10³ TCID50/mL	A	H1N1	Detected
A/Taiwan/42/06	1.15x10³ TCID50/mL	A	H1N1	Detected
A/NY/01/09	5.24x10¹ TCID50/mL	A	H1N1pdm	Detected
A/Canada/6294/09	2.08x10³ TCID50/mL	A	H1N1pdm	Detected
A/New Cal/20/99	1.77x10² TCID50/mL	A	H1N1	Detected
A/Solomon Islands/03/06	2.45x10¹ TCID50/mL	A	H1N1	Detected
A/NY/03/09	7.06 TCID50/mL	A	H1N1pdm	Detected
A/Brisbane/10/07	7.06 TCID50/mL	A	H3N2	Detected
A/Victoria/361/11	2.94x10¹ TCID50/mL	A	H3N2	Detected
A/Perth/16/09	1.77x10¹ TCID50/mL	A	H3N2	Detected
A/Wisconsin/67/05	7.06x10¹ TCID50/mL	A	H3N2	Detected
A/Florida/2/2006	8.25x10⁴ CEID50/mL	A	H3N2	Detected
A/Texas/71/2007	3.25x10³ TCID50/mL	A	H3N2	Detected
A/Texas/50/2012	1.41x10¹ TCID50/mL	A	H3N2	Detected
B/Malaysia/2506/04	3.53x10¹ TCID50/mL	B	Victoria	Detected
B/Florida/02/06	6.29x10¹ TCID50/mL	B	Victoria	Detected
B/Massachusetts/2/12	3.53x10² TCID50/mL	B	Yamagata	Detected

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Influenza Strain	Concentration	Type	Sub Type	Test Result
B/Wisconsin/1/10	$1.70x10^1$ TCID50/mL	B	Yamagata	Detected
B/Texas/6/11	$1.81x10^2$ TCID50/mL	B	Yamagata	Detected
B/Florida/04/06	$1.05x10^2$ TCID50/mL	B	Yamagata	Detected
B/Florida/07/04	$6.14x10^1$ TCID50/mL	B	Yamagata	Detected
B/Lee/40	$1.77x10^1$ TCID50/mL	B	Victoria	Detected
B/Brisbane/60/2008	$1.41x10^1$ TCID50/mL	B	Victoria	Detected
B/Colorado/06/2017	$2.51x10^6$ EID50/mL	B	Victoria	Detected
A/Anhui/1/2013	$1.99x10^7$ EID50/mL	A	A (Avian)	Detected
C/Taylor/1233/1947	$2.10x10^5$ CEID50/mL	C	C	Not Detected*

Analytical Specificity: Cross-Reactivity and Microbial Interference

The OSOM ULTRA PLUS FLU A&B Test was evaluated with 41 organisms (bacterial, viral, fungal) and human DNA, listed below. Bacterial isolates were tested at concentrations of approximately 10° colony forming units per mL (CFU/mL). Chlamydia pneumoniae was tested at a concentration at least 2.0 x 102 CFU/mL. Corynebacterium ulcerans and Streptococcus pyogenes were tested at a concentration of at least 1.0 x 10 CFU/mL. Viral isolates were tested at approximately 105 copy number per mL(CP/mL) or 10 - 108 tissue culture infectious dose 50% per mL (TCID50/mL). Human genomic DNA was diluted to a level greater than the minimum recommended concentration of 104 copies/mL in viral transport media (VTM). No cross-reactivity was observed at the concentrations tested, as all of the microorganisms and human genomic DNA produced negative results.

Bacterial / Fungal Panel

Bordetella pertussis	Legionella pneumophila	Staphylococcus aureus MRSA
Candida albicans	Moraxella catarrhalis	Staphylococcus aureus MSSA
Chlamydia pneumoniae	avirulent Mycobacterium tuberculosis	Staphylococcus epidermidis MRSE
Corynebacterium ulcerans	Mycoplasma hominis	Streptococcus pneumoniae
Escherichia coli	Mycoplasma pneumoniae	Streptococcus pyogenes
Haemophilus influenzae	Neisseria meningitides	Streptococcus salivarius
Klebsiella pneumoniae	Neisseria gonorrhoeae
Lactobacillus acidophilus Z048	Pseudomonas aeruginosa
Viral Panel / DNA
Adenovirus type 1	Human herpes virus 7 (HHV7), SB strain	Metapneumovirus 9 type A1
Adenovirus type 7A	Parainfluenza virus 1	Rhinovirus type 1A
Coronavirus NL63	Parainfluenza virus 2	Enterovirus 68

Respiratory syncytial virus type A2 (RSVA)

Respiratory syncytial virus type B (RSVB)

Parainfluenza virus 3

Metapneumovirus 3 type B1

Measles virus

Mumps

Interfering Substances

Human herpes virus 6 (HHV6), Z29

Cytomegalovirus (CMV)

Epstein-Barr virus (EBV)

Coxsackievirus

The OSOM ULTRA PLUS FLU A&B TEST was evaluated with potential interferents that may be encountered in respiratory specimens. The substances were tested at the concentrations listed in the table below. No interference was observed with the test for any of the substances at the concentrations listed.

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Substance	Potential Interferent	Concentration Tested
Substance Control	Dry swab	N/A
Study Control	Viral transport media (VTM)	N/A
Mucus (Bovine)	Mucin Protein	19 mg/mL
Whole Blood	Whole Blood with EDTA	5% vol/vol
Analgesic	Acetaminophen	0.1 mg/mL
NSAIDs	Aspirin	16.2 mg/mL
NSAIDs	Ibuprofen	40 mg/mL
NSAIDs	Naproxen	55 mg/mL
Nasal Corticosteroids	Dexamethasone	0.5 mg/mL
Nasal Corticosteroids	Fluticasone	50 mg/mL
Nasal Corticosteroids	Mometasone furoate	2.5 µg/mL
Nasal Corticosteroids	Budesonide	25 µg/mL
Nasal Corticosteroids	Flunisolide	68.8 µg/mL
Nasal Corticosteroids	Triamcinolone acetonide	5.5 µg/mL
Nasal Corticosteroids	Beclomethasone	16 µg/mL
Nasal Sprays	Oxymetazoline	0.025% vol/vol
Nasal Sprays	Phenylephrine	0.5% vol/vol
Nasal Sprays	Sodium Chloride	0.325% vol/vol
Nasal Gel	Sabadilla	4x
Nasal Gel	Galphimia glauca	4x, 12x, 30x
Nasal Gel	Histaminum hydrochloricum	12x, 30x, 200x
Nasal Gel	Luffa operculata	4x, 12x, 30x
Nasal Gel	Sulphur	12x, 30x, 200x
Antiviral	Oseltamivir	5 mg/mL
Antibacterial	Tobramycin	40.0 µg/mL
Throat Lozenge	Benzocaine	2.5% soln.
Antibiotic Nasal
Ointment	Mupirocin	0.15mg/mL
Allergy Medicine	Histamine hydrochloricum	1%

Competitive Interference

The performance of the OSOM ULTRA PLUS FLU A&B TEST was evaluated in the presence of high levels of influenza A and influenza B. Contrived high and low titer influenza A (H1N1 and H3N2) and B positive samples were prepared and applied to swabs. The high titer for influenza A was at a concentration of 7.1x103 TCIDs0/mL for H1N1, and 2.2x107 CEID50/mL for H3N2; the high titer for influenza B was set at 1.6x104 TCIDso/mL. The low titer for influenza A was at a concentration of 1.4x102 TCID50/mL for H1N1, and 4.4x105 CEID50/mL for H3N2; the low titer for influenza B was set at 3.2x10- TCID50/mL. High and low viral concentrations of influenza A and B were mixed and tested. No competitive interference on test performance was observed.

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Conclusion 8.

The information presented in this Premarket Notification demonstrates that the performance of the OSOM ULTRA PLUS FLU A&B Test is substantially equivalent in intended use, technological characteristics, and performance to the predicate device.