The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.

The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral 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 December 2023, and July 2024 influenza season when influenza A/H1N1pdm09, influenza A/H3N2 and influenza B/Victoria viruses were the predominant influenza viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If an 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.

Device Description

The Innovita Flu A/B Antigen Rapid Test is a double antibody sandwich immunoassay-based test. The test device consists of the specimen zone and the test zone. The specimen zone contains monoclonal antibody against the Flu A/Flu B antigen labeled with latex microspheres and chicken IgY antibody conjugated with latex microspheres. The test line contains the other monoclonal antibody against Flu A/Flu B antigen. The control line contains rabbit anti-chicken IgY antibody.

After the specimen is applied into the specimen well of the device, antigen in the specimen forms an immune complex with the binding reagent in the specimen zone. Then the complex migrates to the test zone. The test line in the test zone contains antibody from a specific pathogen. If the concentration of the specific antigen in the specimen is higher than LoD of Flu A or Flu B, it will be captured at Flu A or Flu B line and form a red-purple line. In contrast, if the concentration of the specific antigen is lower than LoD, it will not form a red-purple line. The test also contains an internal control system. A red-purple control line (C) should always appear after the test is completed. Absence of a red-purple control line indicates an invalid result. The product contents are listed below.

Contents	Amount	Description
Test cassette	25	Each sealed foil pouch containing one test device and one desiccant
Extraction diluent	25	Vials with 500microliters of solution, mainly composed of Tris-HCl buffer (pH8.4), NaCl and Triton X-100.
Swab	25	Nasopharyngeal swab
Influenza A Positive Control	1	Swab is coated with non-infectious recombinant influenza A antigen
Influenza B Positive Control	1	Swab is coated with non-infectious recombinant influenza B antigen
Negative Control	1	Swab contains inactivated Staphylococcus aureus
Package Insert	1
Quick Reference	1

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Innovita Flu A/B Antigen Rapid Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the clinical study's Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). However, the reported device performance is presented. For analytical performance (LoD, inclusivity, cross-reactivity, interfering substances), the acceptance criterion is generally 100% agreement or no interference/cross-reactivity as implied by the reported results.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Influenza A)	Reported Device Performance (Influenza B)
Analytical Performance
Limit of Detection (LoD)	Detect with high positivity rate (e.g., ≥95%)	96.67% - 100% at specified LoDs	98.33% - 100% at specified LoDs
Inclusivity	100% detection at near LoD concentrations	100% detection for all tested strains	100% detection for all tested strains
Specificity / Cross-Reactivity	No false positives	100% (no cross-reactivity for 49 tested organisms)	100% (no cross-reactivity for 49 tested organisms)
Microbial Interference	No interference	100% (no interference for 49 tested organisms)	100% (no interference for 49 tested organisms)
Interfering Substances	No false positives/negatives	100% (no interference for 30 tested substances)	100% (no interference for 30 tested substances)
Biotin Interference	No interference	No interference up to 4000 ng/mL	No interference up to 4000 ng/mL
Precision/Reproducibility	100% agreement between expected and read result	100% agreement	100% agreement
Clinical Performance
Positive Percent Agreement (PPA)	(Not explicitly stated, but typically a high percentage, e.g., >80%)	85.7% (95% CI: 80.6%-89.5%)	85.7% (95% CI: 72.2%-93.3%)
Negative Percent Agreement (NPA)	(Not explicitly stated, but typically a high percentage, e.g., >95%)	99.5% (95% CI: 98.8%-99.8%)	100% (95% CI: 99.6%-100%)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size (Clinical Study): 1101 evaluable nasopharyngeal swab specimens.
Data Provenance:
- Country of Origin: U.S.
- Study Type: Prospective clinical study. Specimens were collected from subjects with flu-like symptoms during the 2023-2024 influenza season.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the clinical test set was established using an "FDA-cleared influenza A and B molecular assay" as the comparator method. The document does not specify the number of human experts involved in establishing this ground truth or their qualifications. The ground truth relies on the performance characteristics of the molecular assay itself.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the clinical test set results. The comparison appears to be a direct one-to-one comparison between the Innovita Flu A/B Antigen Rapid Test result and the result from the FDA-cleared molecular assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done comparing human readers with AI vs. without AI assistance. This device is a rapid diagnostic test (RDT) with visual interpretation. The precision study involved "untrained operators" to assess reproducibility, but it was not a comparative effectiveness study with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, this study primarily assesses the standalone performance of the rapid diagnostic test device. While human operators interpret the visual results, the performance metrics (PPA, NPA) are based on the device's output compared to the ground truth, without an explicit human-in-the-loop component being evaluated for its improvement with AI, as there is no AI component mentioned for interpretation.

7. Type of Ground Truth Used

The ground truth for the clinical study was: Comparator Method (FDA-cleared influenza A and B molecular assay).

8. Sample Size for the Training Set

The document does not explicitly state a sample size for a "training set." Rapid diagnostic tests typically do not involve machine learning algorithms that require a distinct training set in the same way an AI/ML device would. The development of the assay (e.g., antibody selection, optimization) is a different process from training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of machine learning is not explicitly mentioned or applicable for this type of rapid diagnostic test, the method for establishing its ground truth is not applicable/not described. The analytical studies (LoD, inclusivity, specificity) use laboratory-prepared, characterized samples with known viral concentrations or presence/absence, serving as the "ground truth" for those specific analytical evaluations.

Summary

FDA 510(k) Clearance Letter - Innovita Flu A/B Antigen Rapid Test

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 3, 2025

Innovita (Tangshan) Biological Technology CO., LTD.
℅ Jenny Xia
Regulatory Consultant
LSI International Inc.
504 East Diamond Avenue, Suite H
Gaithersburg, Maryland 20877

Re: K250398
Trade/Device Name: Innovita Flu A/B Antigen Rapid Test
Regulation Number: 21 CFR 866.3328
Regulation Name: Influenza Virus Antigen Detection Test System
Regulatory Class: Class II
Product Code: PSZ
Dated: February 11, 2025
Received: February 12, 2025

Dear Jenny Xia:

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 (the 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 available 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.

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K250398 - Jenny Xia Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250398 - Jenny Xia Page 3

assistance/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,

Noel J. Gerald -SFor

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

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250398
Device Name: Innovita Flu A/B Antigen Rapid Test

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) SUMMARY

Date: July 1, 2025
Submitter: INNOVITA (Tangshan) Biological Technology Co., Ltd.
No. 699 Juxin Street, High-tech Industrial Development Zone,
Qian'an, Hebei, 064400, China.
Contact person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Fax: 301-916-6213
Email: jxia@lsi-consulting.org
Device Name: Innovita Flu A/B Antigen Rapid Test
Classification: Class II

Product Code	CFR #	Panel
PSZ	21 CFR 866.3328	Influenza Virus Antigen Detection Test System Microbiology

Predicate Devices:
K191514, CareStart Flu A&B Plus
Intended Use

Page 6

Device Description

Contents	Amount	Description
Test cassette	25	Each sealed foil pouch containing one test device and one desiccant
Extraction diluent	25	Vials with 500μL of solution, mainly composed of Tris-HCl buffer (pH8.4), NaCl and Triton X-100.
Swab	25	Nasopharyngeal swab
Influenza A Positive Control	1	Swab is coated with non-infectious recombinant influenza A antigen
Influenza B Positive Control	1	Swab is coated with non-infectious recombinant influenza B antigen
Negative Control	1	Swab contains inactivated Staphylococcus aureus
Package Insert	1
Quick Reference	1

Substantial Equivalence Information

A summary comparison of features of the Innovita Flu A/B Antigen Rapid Test and the predicate device is provided in the following table.

Device & Predicate Device	CareStart Flu A&B Plus K191514	Innovita Flu A/B Antigen Rapid test
Regulation Name	Influenza virus antigen detection	Same
Regulatory Class	Class II	Same
Product Code	PSZ	Same
Assay Target	Influenza A and B nucleoprotein	Same

Page 7

Device & Predicate Device	CareStart Flu A&B Plus K191514	Innovita Flu A/B Antigen Rapid test
Intended Use	The CareStart Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should 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 basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant	The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral 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 December 2023, and July 2024 influenza season when influenza A/H1N1pdm09, influenza

Page 8

	influenza viruses in circulation. When other influenza 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 the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.	A/H3N2 and influenza B/Victoria viruses were the predominant influenza viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If an 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.
Specimens Type	Nasopharyngeal swabs	Same
Assay Result	Qualitative	Same
Technology	Immunochromatographic assay	Same
Instrumentation	None	Same
Device Format	Cassette	Same
Detection Format	Visual determination of presence or absence of colored line indicators for the test line and control line on the test strip indicate the presence of influenza A and/or B antigen.	Same
Time to Result	10 minutes	10 ~30 minutes

Performance Summary

Analytical Performance

Page 9

a. Limit of Detection (LoD)

To determine the Limit of Detection (LoD) of Innovita Flu A/B Antigen Rapid Test, four influenza A virus with two common currently or recently circulating influenza A subtypes (i.e., H3N2, H1N1) and four influenza B virus with two genetic lineages (i.e., Victoria lineage and Yamagata lineage) were tested in this study. In this study, each influenza virus strain of the panel was serially diluted to the concentration at which at least one negative result was obtained from replicate testing.

The estimated LoD for each virus strain was confirmed by testing twenty replicates per lot with three different lots. The results presented in the table below.

Strain Type	Strain	LOD (TCID50/mL)	LOD Per Swab (TCID50/Swab)	Positive Rate
Flu A virus (H3N2)	A/Virginia/ATCC6/2012	2.23×10³	1.12×10²	60/60 (100%)
	A/Baltimore/JH-0586/2022	2.50×10³	1.25×10²	60/60 (100%)
Flu A virus (H1N1)	A/Dominican Republic/7293/2013 pdm09	5.00×10²	2.50×10¹	58/60 (96.67%)
	A/Virginia/ATCC1/2009 TC isolate	8.00×10²	4.00×10¹	60/60 (100%)
Flu B virus (Victoria lineage)	B/New Jersey/1/2012	2.20×10³	1.10×10²	59/60 (98.33%)
	B/Michigan/01/2021	1.43×10³	7.15×10¹	60/60 (100%)
Flu B virus (Yamagata lineage)	B/Brisbane/9/14	1.26×10²	6.30×10⁰	59/60 (98.33%)
	B/Panama/45/90	9.50×10²	4.75×10¹	60/60 (100%)

b. Inclusivity

To determine the detectability of the Innovita Flu A/B Antigen Rapid Test, twenty-nine strains of influenza A virus representing each of three common currently or recently circulating influenza A subtypes (i.e., H1N1 and H3N2) and twelve strains of influenza B virus representing each of two influenza B genetic lineages (i.e., Yamagata lineage and Victoria lineage) were tested in this study. In this study, each influenza virus strain was serially diluted to a concentration near the LoD and tested in replicates of 10 with the Innovita Flu A/B Antigen Rapid Test. All viruses were detected in all ten replicates per lot with three different lots at the concentrations shown below.

Strain	Substitute strain	Inclusivity
Flu A virus (H1N1)	A/California/08/2009 pdm09	1.6×10⁴ CEID50/mL
	A/California/04/2009 (H1N1) pdm09	1.1×10² TCID50/mL
	A/Michigan/272/2017	9.6×10³ TCID50/mL
	A/New Hampshire/02/2010 (H1N1) pdm09	1.8×10⁴ CEID50 /mL
	A/South Carolina/2/2010 (H1N1) pdm09	2.5×10⁵ CEID50 /mL
	A/St. Petersburg/61/2015	9.3×10⁵ CEID50 /mL
	A/Michigan/45/2015 (H1N1) pdm09	1×10⁴CEID50/mL
	A/Baltimore/JH-22377/2022	1.6×10⁵ TCID50/mL

Page 10

	A/Massachusetts/15/2013 (H1N1) pdm09	1.6×10⁴CEID50/mL
	A/Iowa/53/2015 (H1N1) pdm09	2.9×10⁴CEID50/mL
	A/Bretagne/06091/2023	5.5×10³ PFU/mL
	A/Bangladesh/3002/2015 (H1N1) pdm09	1.3×10⁴CEID50/mL
	A/California/07/2009 pdm09	2.3×10⁴ CEID50/mL
Flu A virus (H3N2)	A/Perth/16/2009	1.1×10⁵TCID50/mL
	A/Baltimore/JH-286/2021	2.8×10⁵ TCID50/mL
	A/Baltimore/JH-335/2022	8.9×10⁴ TCID50/mL
	A/Baltimore/JH-0440/2022	2.8×10⁴ TCID50/mL
	A/Hong Kong/8/68	1.58×10³ CEID50/mL
	A/Wisconsin/67/2005 (H3N2)	1.5×10⁵ CEID50/mL
	A/Aichi/2/68	2.3×10³ CEID50/mL
	A/Alaska/232/2015	2.6×10⁴ CEID50/mL
	A/Michigan/15/2014	9.3 × 10³ FFU/mL
	A/Switzerland/9715293/2013	1.6×10⁵ CEID50/mL
	A/California/2/2014	5.8×10² TCID50/mL
	A/Texas/71/2017	9.3 × 10³ FFU/mL
	A/Indiana/08/2011 (H3N2) v	8.1×10² TCID50/mL
	A/Minnesota/11/2010 (H3N2) v	2.2×10⁴ CEID50/mL
	A/Singapore/INFIMH-16-0019/2016	2.2×10⁴ CEID50/mL
	A/Hong Kong/4801/2014	9.6×10⁵ CEID50 / mL
Flu B virus (Victoria lineage)	B/Baltimore/JH002/2021	1.6×10⁴ TCID50/mL
	B/Florida/78/2015	2.8×10⁴ TCID50/mL
	B/Colorado/6/2017	1.6×10⁴ CEID50/mL
	B/New Hampshire/01/2021	1.3×10²TCID50/mL
	B/Brisbane/60/2008	1×10⁴ CEID50/mL
	B/Hong Kong/286/2017	2.7×10³TCID50/mL
	B/Maryland/15/2016	1.3×10³ TCID50/mL
Flu B virus (Yamagata lineage)	B/Guangdong/120/00	1.68×10²TCID50/mL
	B/Texas/6/11	3.8×10²TCID50/mL
	B/Wisconsin/1/2010 BX-41A	1.8×10⁵ CEID50/mL
	B/Florida/4/2006	5×10⁴ CEID50/mL
	B/Massachusetts/2/2012	1.0×10⁴TCID50/mL

c. Specificity / Cross Reactivity and Microbial Interference

The potential cross-reactivity of a panel of common organisms was evaluated with influenza negative samples using the Innovita Flu A/B Antigen Rapid Test. Potential microbial interference was evaluated with samples containing influenza A or influenza B at concentrations 2X LoD. A total of 49 organisms were tested. All influenza negative samples gave negative results at the tested concentrations showing no cross-reactivity with Innovita Flu A/B Antigen Rapid Test. All samples with influenza A or influenza B tested positive showing no microbial interference at the concentrations tested.

Page 11

Microorganism	Concentration Tested	Negative sample	Flu A positive sample	Flu B positive sample
		Lot 1	Lot 2	Lot 3
Human rhinovirus 1A	6.6×10⁶ PFU/mL	3-	3-	3-
Human parainfluenza virus 1 (HPIV-1)	3.2×10⁶ TCID50/mL	3-	3-	3-
Acinetobacter calcoaceticus	6.2×10⁷ CFU/mL	3-	3-	3-
Human adenovirus 1	3.2×10⁶ TCID50/mL	3-	3-	3-
Human mastadenovirus B7	1.78×10⁶ TCID50/mL	3-	3-	3-
Bordetella pertussis	3.08×10⁶ CFU/mL	3-	3-	3-
Candida albicans	7.3×10⁷ CFU/mL	3-	3-	3-
Chlamydophila pneumoniae	4.6×10⁷ CFU/mL	3-	3-	3-
Human coronavirus 229E	3.2×10⁵ TCID50/mL	3-	3-	3-
Beta coronavirus 1 (Human coronavirus OC43)	1.0×10⁵ TCID50/mL	3-	3-	3-
Corynebacterium diphtheriae	1.28×10⁸ CFU/mL	3-	3-	3-
Human Coxsackievirus B4	3.2×10⁶ TCID50/mL	3-	3-	3-
Cytomegalovirus	1.4×10⁵ TCID50/mL	3-	3-	3-
Enterococcus faecalis	1.78×10⁹ CFU/mL	3-	3-	3-
Escherichia coli	2.88×10⁷ CFU/mL	3-	3-	3-
Gardnerella vaginalis	9.92×10⁶ CFU/mL	3-	3-	3-
Haemophilus influenzae	3.36×10⁷ CFU/mL	3-	3-	3-
Klebsiella pneumoniae subsp. pneumoniae	1.04×10⁹ CFU/mL	3-	3-	3-
Lacticaseibacillus casei	4.32×10⁸ CFU/mL	3-	3-	3-
Legionella pneumophila subsp. pneumophila	1.12×10⁸ CFU/mL	3-	3-	3-
Listeria monocytogenes	2.28×10⁹ CFU/mL	3-	3-	3-
Measles virus	1.78×10⁵ TCID50/mL	3-	3-	3-
Human Metapneumovirus 27 (hMPV-27) Type A2	7.6×10⁵ TCID50/mL	3-	3-	3-
Moraxella (Branhamella) catarrhalis	8.8×10⁸ CFU/mL	3-	3-	3-
Mumps virus	9.84×10⁶ TCID50/mL	3-	3-	3-
Mycobacterium tuberculosis	3.32×10⁷ CFU/mL	3-	3-	3-
Mycoplasma pneumoniae	6.6×10⁸ CFU/mL	3-	3-	3-
Neisseria gonorrhoeae	2.8×10⁷ CFU/mL	3-	3-	3-

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Neisseria meningitidis	1.44×10⁶ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Neisseria sicca	8.4×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Human parainfluenza. virus 2	1.78×10⁶ TCID50/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Human parainfluenza virus 3	3.2×10⁷ TCID50/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Proteus vulgaris	1.04×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Pseudomonas paraeruginosa	6.4×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Human respiratory syncytial virus B	5.6×10⁵ TCID50/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Rubella	1.78×10⁵ TCID50/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
SARS-CoV-2	3.16×10⁵ TCID50/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Serratia marcescens subsp. marcescens	2.64×10⁹ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Staphylococcus aureus subsp. aureus	1.16×10⁹ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Staphylococcus epidermidis	2.12×10⁷ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus agalactiae	1.28×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus anginosus	2.32×10⁷ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus dysgalactiae subsp equisimilis	1.12×10⁹ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus mutans	4.42×10⁹ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus pneumoniae	3.4×10⁶ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus pyogenes	2.8×10⁷ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus sanguinis	1.52×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus constellatus	4.28×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Streptococcus intermedius	8.34×10⁸ CFU/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+

d. Interfering Substances

Potentially interfering substances present in respiratory specimens or that may be artificially introduced into the oropharynx or nasopharynx cavity were studied with the Innovita Flu A/B Antigen Rapid Test. The positive samples were prepared using the influenza A and B virus strains diluted to concentrations 2X LoD. Each influenza strain combined with each interfering substance was evaluated separately. Negative samples were prepared by adding each interfering substance to the negative nasal fluid. Each positive and negative sample, combined with each interfering substance, was tested in triplicate for each lot with three different lots. None of the tested potential interfering substances showed false positive or false negative test results using Innovita Flu A/B Antigen Rapid Test with influenza positive and negative samples at the concentrations specified below.

Potentially interfering substances	Concentration Tested	Negative sample	Flu A positive sample	Flu B positive sample

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		Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
Acetaminophen	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Acetyl salicylic acid	15 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Beclomethasone	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Benzocaine	5 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Budesonide	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Chlorpheniramine maleate	5 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Dexamethasone	1 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Dextromethorphan HBr	2 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Diphenhydramine HCl	5 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Ephedrine HCl	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Flunisolide	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Fluticasone	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Guaiacol Glyceryl Ether	20 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Histamine Dihydrochloride	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Menthol	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Mometasone	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Mucin	3 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Mupirocin	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
OTC Throat drop (Halls)	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
OTC Throat drop (Ricola)	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
OTC Nasal spray (Afrin)	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
OTC Nasal spray (Vicks Sinex)	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
OTC Nasal spray (Zicam)	15%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Oxymetazoline HCl	10 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Phenylephrine HCl	5 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Phenylpropanolamine	5 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Tobramycin	1 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Triamcinolone	1 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+
Whole Blood	3%	3-	3-	3-	3+	3+	3+	3+	3+	3+
Zanamivir	1 mg/mL	3-	3-	3-	3+	3+	3+	3+	3+	3+

The biotin interfering effects using Innovita Flu A/B Antigen Rapid Test were tested. No interference was observed with biotin concentrations up to 4000 ng/mL.

e. Precision/Reproducibility Study

A precision study was performed to evaluate the precision of the Innovita Flu A/B Antigen Rapid Test. The study was performed at three external testing sites consisting of seven samples at various virus concentrations including near the respective LoD (i.e., true negative, high negative influenza A, low positive influenza A, moderate positive influenza A, high negative influenza B, low positive influenza B, and moderate positive influenza B). These samples were tested by six (6) untrained operators at 5 replicates per day and last over 5 days, i.e., 5 replicates x 6 operators x 5

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days= 150 replicates per concentration and a total of 1050 data points collected. Three (3) test lots were used in this study, so lot-to-lot variability was also assessed. Fifty (50) μL of the prepared sample were applied to kit swabs, shipped and stored frozen at -20°C until testing. The results were 100% agreement between expected and read result within replicates, by lot, by operator, by day, between sites and overall.

Sample	Positive Percent Agreement						Total Positive Percent Agreement (95% Confidence Intervals)
	Site 1/Lot 1		Site 2/Lot 2		Site 3/Lot 3
	Flu A	Flu B	Flu A	Flu B	Flu A	Flu B	Flu A
Negative swab sample	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/150 (0%) (0%-2.5%)
Flu A high negative swab sample (0.1×LOD)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/150 (0%) (0%-2.5%)
Flu A Low positive swab sample (1×LOD)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	150/150 (100%) (97.5%-100%)
Flu A moderate positive swab sample (3×LOD)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	150/150 (100%) (97.5%-100%)
Flu B high negative swab sample (0.1×LOD)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/150 (0%) (0%-2.5%)
Flu B Low positive swab sample (1×LOD)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/150 (0%) (0%-2.5%)
Flu B moderate positive swab sample (3×LOD)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/50 (0%)	50/50 (100%)	0/150 (0%) (0%-2.5%)

f. Prospective Clinical Study

The prospective clinical study was carried out during the 2023-2024 influenza season at three clinical sites in the U.S. and compared against an FDA-cleared influenza A and B molecular assay. A total of 1109 subjects with flu-like symptoms were enrolled in the study. Of those, 8 specimens were unevaluable (eight samples were lost in transit to the laboratory). A total of 1101 nasopharyngeal swab specimens were considered evaluable. Two nasopharyngeal swabs were collected from each subject. At all sites, the first collected nasopharyngeal swab was eluted in 3 ml of viral transport media and transported to the central laboratory for testing an FDA-cleared molecular assay as a comparator method. The second collected nasopharyngeal swab was tested directly with the Innovita Flu A/B Antigen Rapid Test according to the product instructions.

The following tables show the number of influenza A and influenza B positive cases and its percentage in four subject age categories, as observed during the clinical study.

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Age Group	Positivity Rates for Influenza A based on an FDA-cleared molecular test during the Clinical Study
	Number of Subjects	Number of Influenza A Positives	Influenza A Positivity Rate
≤5 Years of Age	463	121	26.1%
6-21 Years of Age	399	95	23.8%
≥22 Years of Age	239	21	8.8%
Total	1101	237	21.5%

Age Group	Positivity Rates for Influenza B based on an FDA-cleared molecular test during the Clinical Study
	Number of Subjects	Number of Influenza B Positives	Influenza B Positivity Rate
≤5 Years of Age	463	14	3.0%
6-21 Years of Age	399	19	4.8%
≥22 Years of Age	239	9	3.8%
Total	1101	42	3.8%

The performance of the Innovita Flu A/B Antigen Rapid Test for influenza A and influenza B as compared to the comparator method is presented in the tables below.

Innovita Flu A/B Antigen Rapid Test - Influenza A	Molecular Comparator
	Positive	Negative
Positive	203	4
Negative	34	860
Total	237	864

Positive Percent Agreement (PPA) 85.7% (95% CI: 80.6%-89.5%)
Negative Percent Agreement (NPA) 99.5% (95% CI: 98.8%-99.8%)

Innovita Flu A/B Antigen Rapid Test - Influenza B	Molecular Comparator
	Positive	Negative
Positive	36	0
Negative	6	1059
Total	42	1059

Positive Percent Agreement (PPA) 85.7% (95% CI: 72.2%-93.3%)
Negative Percent Agreement (NPA) 100% (95% CI: 99.6%-100%)

11. Conclusion

Based on the data submitted in this traditional 510(k) submission, the Innovita Flu A/B Antigen Rapid Test has been shown to be substantially equivalent in terms of

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intended use, technological characteristics, and assay performance to the predicate device.

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.