The Visby Medical Respiratory Health Test is a single-use (disposable), fully integrated, automated Reverse Transcription Polymerase Chain Reaction (RT-PCR) in vitro diagnostic test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B RNA in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, and influenza B can be similar.

The Visby Medical Respiratory Health Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, and influenza B viral RNA are generally detectable in nasopharyngeal swab and anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.

Positive results are indicative of the identified virus, but do not rule out bacterial infection or co-infection with other organisms not detected by the test. The agent(s) detected by the Visby Medical Respiratory Health Test may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Device Description

The Visby Medical Respiratory Health Test is a single-use (disposable), fully integrated, compact device containing a reverse transcription polymerase chain reaction (RT-PCR) based assay for qualitative detection of influenza B, and/or SARS-CoV-2 viral RNA in upper respiratory tract specimens. The device automatically performs all steps required to complete lysis, reverse transcription (RT), PCR amplification, and detection.

Specimen collected using nasopharyngeal (NP) or anterior nasal (AN) swabs (without transport media) are placed in the Visby Medical Respiratory Health Buffer and then transferred into the sample port of the device using the provided fixed volume pipette. The sample enters a lysis module and rehydrates the RT enzyme and RT primers. The mixture then moves through a sample preparation module where viruses and human cells are simultaneously lysed, and RNA is reverse transcribed. The resulting fluid (containing cDNA) is then mixed with lyophilized PCR reagents containing the DNA polymerase enzyme and PCR primers. The PCR mixture (containing cDNA template and reagents) is then thermal cycled to amplify the targets, including human beta-2 microglobulin (B2M) RNA, which serves as a process control. After PCR, the biotinylated product is hybridized to covalently bound capture probes at specific locations along a flow channel. The flow channel is configured to facilitate an enzymatic reaction that uses streptavidin bound horseradish peroxidase (HRP) and a colorimetric substrate that forms a purple precipitate. The operator observes a color change at the specific locations indicating the presence of an amplified target. Test results can be expected in approximately 30 minutes: illumination of a "DONE" status light on the front of the device and a purple color in the "RESULTS VALID" spot, indicate a successful test. A purple spot adjacent to "Flu A", "Flu B", and/or "COVID-19" signifies the presence of, influenza A, influenza B, and/or SARS-CoV-2 viral RNA.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate table. However, based on the Summary of Performance Data, the inferred acceptance criteria are the achieved Positive Percentage Agreement (PPA) and Negative Percentage Agreement (NPA) values in the clinical evaluation. The study aims to demonstrate substantial equivalence to the predicate device, implying that the performance needs to be comparable or better.

Here's a table summarizing the reported device performance, which implicitly represents the met acceptance criteria:

Target	Specimen Type	Reported PPA (95% CI)	Reported NPA (95% CI)
Influenza A	NP	97.1% (85.1-99.5%)	99.5% (98.7-99.8%)
Influenza A	AN	96.8% (89.1-99.1%)	99.2% (98.1-99.7%)
Influenza A	NP+AN	96.9% (91.3-98.9%)	99.4% (98.8-99.7%)
Influenza B	NP	100% (79.6-100%)	99.8% (99.1-99.9%)
Influenza B	AN	100% (79.6-100%)	99.9% (99.1-100%)
Influenza B	NP+AN	100% (88.7-100%)	99.8% (99.4-99.9%)
SARS-CoV-2	NP	96.3% (91.6-98.4%)	99.0% (97.9-99.5%)
SARS-CoV-2	AN	98.3% (94.0-99.5%)	99.1% (97.9-99.6%)
SARS-CoV-2	NP+AN	97.2% (94.4-98.7%)	99.0% (98.3-99.5%)

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: A total of 1,501 subjects were included in the performance analysis after exclusions. 1,575 Visby tests were initially performed.
- Data Provenance: Prospectively collected fresh specimens from subjects presenting with signs and symptoms of a viral respiratory infection at five CLIA Waived study sites in the US (urgent care and family care clinics). Specimens were collected and tested between May 2022 and Feb 2024.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Instead, it states that the comparator assays define the ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document describes comparing the Visby Medical Respiratory Health Test results against an "FDA-cleared influenza molecular test and an FDA-EUA authorized SARS-CoV-2 RT-PCR test as a comparator." It also mentions "alternate molecular assay" for discordant results (footnotes a, b, e, f, g, h, i, j in Table 2). This indicates that the ground truth was established by these comparator assays, potentially with some form of reference-standard-based comparison and possibly resolution of discrepancies with alternate assays, rather than a multi-expert adjudication method on the test set itself.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test for molecular detection of viruses, not an AI-assisted diagnostic imaging or human-read interpretation system. The "operators" in the reproducibility study were "non-laboratorians representing healthcare professionals," but their performance was evaluated against expected results for spiked samples, not in comparison to their own performance with and without an AI assistant on clinical cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was primarily done for the device. The clinical study evaluated the device's ability to detect viral RNA in specimens. While "typical CLIA Waived operators" performed the test, their role was to execute the device's protocol, and the device's detection accuracy was then compared against the comparator assays. The "device automatically performs all steps required to complete lysis, reverse transcription (RT), PCR amplification, and detection," implying it functions as a standalone diagnostic unit once the sample is loaded.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical evaluation was established by comparator molecular assays: an "FDA-cleared influenza molecular test" and an "FDA-EUA authorized SARS-CoV-2 RT-PCR test." Discordant results were sometimes further investigated with an "alternate molecular assay."
The sample size for the training set:
- The document does not specify a separate training set or its sample size. For IVD devices like this RT-PCR test, the "training" typically refers to the assay development and optimization process in the lab, rather than a distinct training set in the way AI/ML models are trained. The clinical performance study evaluates the final, optimized device.
How the ground truth for the training set was established:
- As no distinct "training set" in the context of an AI/ML model is described, this information is not applicable. The development and optimization of such a diagnostic test would involve analytical studies (e.g., LoD, inclusivity, cross-reactivity) where the "ground truth" for those specific experiments (e.g., known concentrations of viral targets) is established by careful spiking and molecular characterization in a laboratory setting.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 19, 2025

Visby Medical, Inc. Jennifer Albrecht Director of Regulatory Affairs 3010 North First Street San Jose, California 95134

Re: K242526

Trade/Device Name: Visby Medical Respiratory Health Test Regulation Number: 21 CFR 866.3981 Regulation Name: Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test Regulatory Class: Class II Product Code: OOF Dated: August 23, 2024

Dear Jennifer Albrecht:

Received: August 26, 2024

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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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 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-safetyreporting-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory

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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,

Anna M. Mielech -S

Anna Mielech, Ph.D. Deputy Branch Chief (Acting) Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242526

Device Name Visby Medical Respiratory Health Test

Indications for Use (Describe)

The Visby Medical Respiratory Health Test is a single-use (disposable), fully integrated, automated Reverse Transcription Polymerase Chain Reaction (RT-PCR) in vitro diagnostic test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza B RNA in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza B can be similar.

Positive results are indicative of the identified virus, but do not rule out bacterial infection or co-infection with other organisms not detected by the test. The agent(s) detected by the Visby Medical Respiratory Health Test may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

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

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510(k) Summary

A. Submitter
B.

Name:Address:Phone:	Visby Medical, Inc.3010 N. First StreetSan Jose, CA 951341-833-468-4729
Contact:	Jennifer Albrecht
Date Prepared:	February 16, 2025
Device
Name of Device:	Visby Medical Respiratory Health Test
Common Name:	Same
Common Name:	Sams
Classification Name:	Multi-Target Respiratory Specimen Nucleic Acid TestIncluding Sars-Cov-2 And Other Microbial Agents
Regulatory Classification:	Class II
Regulation:	21 CFR 866.3981
Primary Product Code:	QOF

C. Predicate Device

DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct (K220963)

D. Device Description

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microglobulin (B2M) RNA, which serves as a process control. After PCR, the biotinylated product is hybridized to covalently bound capture probes at specific locations along a flow channel. The flow channel is configured to facilitate an enzymatic reaction that uses streptavidin bound horseradish peroxidase (HRP) and a colorimetric substrate that forms a purple precipitate. The operator observes a color change at the specific locations indicating the presence of an amplified target. Test results can be expected in approximately 30 minutes: illumination of a "DONE" status light on the front of the device and a purple color in the "RESULTS VALID" spot, indicate a successful test. A purple spot adjacent to "Flu A", "Flu B", and/or "COVID-19" signifies the presence of, influenza A, influenza B, and/or SARS-CoV-2 viral RNA.

E. Intended Use

Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other organisms not detected by the test. The agent(s) detected by the Visby Medical Respiratory Health Test may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient manaqement decisions.

F. Substantial Equivalence

The Visby Medical Respiratory Health test is substantially equivalent to DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct, K220963.

The following table compares the Visby Medical Respiratory Health Test to DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct and outlines the similarities and differences between the two tests.

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Characteristic	Predicate Device:DiaSorin MolecularSimplexa COVID-19 & Flu A/B Direct(K220963)	Subject Device:Visby MedicalRespiratory Health(K242526)
Regulation	21 CFR 866.3981	Same
Product Code	QOF	Same
Device Class	Class II	Same
Technology/Detection	Real-time Reverse TranscriptionPolymerase Chain Reaction (RT-PCR)system, qualitative	Same
Characteristic	Predicate Device:DiaSorin MolecularSimplexa COVID-19 & Flu A/B Direct(K220963)	Subject Device:Visby MedicalRespiratory Health(K242526)
Intended Use	The DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct is a real-time RT-PCRassay intended for use on the LIAISONMDX instrument for the in vitro qualitativedetection and differentiation of nucleicacid from severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2),influenza A virus and influenza B virus innasopharyngeal swabs (NPS) fromindividuals with signs and symptoms ofrespiratory tract infection.The Simplexa COVID-19 & Flu A/B Directassay is intended for use as an aid in thedifferential diagnosis of SARS-CoV-2,influenza A and influenza B infection.Negative results do not preclude SARS-CoV-2, influenza A or influenza Binfection and should not be used as thesole basis for patient managementdecisions. Positive results do not rule outcoinfections with other organisms.Results should be combined with clinicalobservations, patient history, andepidemiological information.The Simplexa COVID-19 & Flu A/B Directassay is intended for use by qualified andtrained clinical laboratory personnelspecifically instructed and trained in thetechniques of real-time PCR and in vitrodiagnostic procedures.	The Visby Medical Respiratory HealthTest is a single-use (disposable), fullyintegrated, automated ReverseTranscription Polymerase Chain Reaction(RT-PCR) in vitro diagnostic test intendedfor the simultaneous qualitative detectionand differentiation of severe acuterespiratory syndrome coronavirus 2(SARS-CoV-2), influenza A, and influenzaB RNA in nasopharyngeal swab andanterior nasal swab specimens fromindividuals with signs and symptoms ofrespiratory tract infection. Clinical signsand symptoms of respiratory tractinfection due to SARS-CoV-2, influenzaA, and influenza B can be similar.The Visby Medical Respiratory HealthTest is intended for use as an aid in thedifferential diagnosis of SARS-CoV-2,influenza A, and influenza B infection ifused in conjunction with other clinical andepidemiological information, andlaboratory findings. SARS-CoV-2,influenza A, and influenza B viral RNA aregenerally detectable in nasopharyngealswab and anterior nasal swab specimensduring the acute phase of infection. Thistest is not intended to detect influenza Cvirus infections.Positive results are indicative of thepresence of the identified virus, but do notrule out bacterial infection or co-infectionwith other organisms not detected by thetest. The agent(s) detected by the VisbyMedical Respiratory Health Test may notbe the definitive cause of disease.Negative results do not preclude SARS-CoV-2, influenza A, or influenza Binfection. The results of this test shouldnot be used as the sole basis fordiagnosis, treatment, or other patientmanagement decisions.
Characteristic	Predicate Device:DiaSorin MolecularSimplexa COVID-19 & Flu A/B Direct(K220963)	Subject Device:Visby MedicalRespiratory Health(K242526)
Indication for Use	Symptomatic patients;Rx - For Prescription Use Only	Same
Assay Targets	SARS-CoV-2, influenza A virus andinfluenza B virus	Same
Sample to answersystem	Automated	Same
Specimen Types	Nasopharyngeal Swab	Nasopharyngeal Swab;Anterior Nasal Swab
Sample Extraction	Self-contained and automated afterspecimen sample elution	Same
Assay Results	Qualitative	Same
Instrument System	LIAISON MDX	N/A, self-contained assay and instrumentsystem
Assay Controls	Internal processing control (IPC), Externalcontrols available.	Same
Turn-around Time	Approximately 90 minutes to results.	Approximately 30 minutes to results.

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G. Summary of Performance Data

Clinical Evaluation

Performance characteristics of the Visby Medical Respiratory Health Test were established in a clinical study that included testing of prospectively collected fresh specimens. The objective of this study was to establish the clinical performance of the Visby Medical Respiratory Health Test for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral RNA in clinical specimens when in the intended use setting. This study was conducted at five CLIA Waived testings in the US. All study specimens were tested with the Visby Medical Respiratory Health Test by typical CLIA Waived operators according to the Quick Reference Guide (QRG) and Instructions for Use (IFU). Specimens were collected and tested between May 2022 and Feb 2024.

Prospective Sample Testing

Subjects presenting with signs and symptoms of a viral respiratory infection were prospectively enrolled at five CLIA Waived study sites in the US including urgent care and family care clinics. One NP or dual nostril AN swab specimen was placed directly in Visby Respiratory Health Buffer and tested with the Visby device. The samples were also tested with an FDA-cleared influenza molecular test and an FDA-EUA authorized SARS-CoV-2 RT-PCR test as a comparator.

A total of 1,592 subjects were enrolled in the study. Ninety one (91) study specimens were excluded from the performance analysis due to of lack of a valid comparator result

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(n=53), lack of a valid Visby test result (n=21), the subject did not meet inclusion criteria (n=10), or for protocol deviations (n=6). One subject withdrew from the study. This left 1,501 subjects for performance analysis of the Visby Medical Respiratory Health Test. The distribution of subjects in the performance analysis by sex and age range is presented in Table 1.

Category	Number Evaluated (as %)
Sex	Male 573 (38.2%)
	Female 928 (61.8%)
Age	≤ 5 years 85 (5.7%)
	6 - 21 years 325 (21.7%)
	22 - 59 years 883 (58.8%)
	≥60 years 208 (13.9%)
Total	1501

Table 1. Demographic Summary - Enrollment from May 2022 to Feb 2024
---------------------------------------------------------------------	--

A total of 1,575 Visby tests were performed on subjects that met the inclusion criteria, did not experience a protocol deviation, did not withdraw from the study. Of these 79 (5.0%) had an initial invalid test result of which 21 (1.3%) were invalid when retested. Of the 840 NP swab specimens tested, 30 (3.6%) had an initial invalid test result of which 5 (0.6%) were invalid when retested. Of the 735 AN swab specimens tested, 49 (6.7%) had an initial invalid test result of which 16 (2.2%) were invalid when retested.

The positive percentage agreement (PPA) and neqative percentage agreement (NPA) of influenza A, influenza B, and SARS-CoV-2 are shown in Table 2 below.

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	SpecimenType (NP/AN)	TP	FP	TN	FN	PPA (95% CI)	NPA (95% CI)
Influenza A	NP	33	4a	791	1c	97.1%(85.1-99.5%)	99.5%(98.7-99.8%)
	AN	61	5b	604	2d	96.8%(89.1-99.1%)	99.2%(98.1-99.7%)
	NP+AN	94	9	1395	3	96.9%(91.3-98.9%)	99.4%(98.8-99.7%)
Influenza B	NP	15	2e	812	0	100%(79.6-100%)	99.8%(99.1-99.9%)
	AN	15	1f	656	0	100%(79.6-100%)	99.9%(99.1-100%)
	NP+AN	30	3	1468	0	100%(88.7-100%)	99.8%(99.4-99.9%)
SARS-CoV-2	NP	130	7g	687	5i	96.3%(91.6-98.4%)	99.0%(97.9-99.5%)
	AN	116	5h	549	2j	98.3%(94.0-99.5%)	99.1%(97.9-99.6%)
	NP+AN	246	12	1236	7	97.2%(94.4-98.7%)	99.0%(98.3-99.5%)

Table 2. Prospective Fresh NP and AN Swab Specimen Performance - Enrollment from May 2022 to Feb 2024 (Visby vs. Comparator Assays)

a 3 of 4 false positive NP specimens tested positive and one tested negative with an alternate molecular assay

b 5 of 5 false positive AN specimens tested positive with an alternate molecular assay

& 1 false negative NP specimen tested positive with an alternate molecular assay

d 2 false negative AN specimen tested positive with an alternate molecular assay

e 2 of 2 false positive NP specimens tested positive with an alternate molecular assay

「 1 of 1 false positive AN specimens tested positive with an alternate molecular assay

9 5 of 7 false positive NP specimens tested positive and 2 tested negative with an alternate molecular assay

h 4 of 5 false positive AN specimens tested positive, and 1 tested negative with an alternate molecular assay

1 3 of 5 false negative NP specimens tested negative and 2 tested positive with an alternate molecular assay

İ 1 of 2 false negative AN specimen tested negative and 1 tested positive with an alternate molecular assay

Reproducibility

A study was performed to evaluate the reproducibility of the Visby Medical Respiratory Health Test when used by untrained users in CLIA Waived settings. The operators performing the testing were non-laboratorians representing healthcare professionals that may be encountered at such sites. The study evaluated a seven (7) member panel composed of NP swabs seeded with unspiked clinical matrix (negative) and NP swabs seeded with clinical matrix individually spiked with low (1x LoD) or moderate (3-5x LoD) concentrations of the three target viruses.

A total of six (6) study operators (2 operators at each site) tested the panel three (3) times each testing day, over six (6) non-consecutive days. Three reagent lots were used in the study. Each lot was used for two (2) days of testing. The composition of the panel

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members along with a summary of results (correct count / total count) and percent agreement with the expected results for each panel member is presented in Table 3 below.

Panel Member	Site 1% Agreement(count)	Site 2% Agreement(count)	Site 3% Agreement(count)	Overall Agreement% Agreement(count)	95% CI
Influenza AModerate Positive	100.0%(36/36)	100.0%(36/36)	100.0%(36/36)	100.0%(108/108)	96.6%-100.0%
Influenza A LowPositive	94.4%(34/36)	100.0%(36/36) a	88.9%(32/36)	94.4%(102/108) a	88.4%-97.4%
Influenza BModerate Positive	97.2%(35/36)	100.0%(36/36)	100.0%(36/36)	99.1%(107/108)	94.9%-99.8%
Influenza B LowPositive	97.2%(35/36)	100.0%(36/36)	91.7%(33/36)	96.3%(104/108)	90.9%-98.6%
SARS-CoV-2Moderate Positive	100.0%(36/36)	100.0%(36/36)	100.0%(36/36)	100.0%(108/108)	96.6%-100.0%
SARS-CoV-2 LowPositive	97.2%(35/36)	100.0%(36/36)	88.9%(32/36)	95.4%(103/108)	89.6%-98.0%
Negative	100.0%(36/36)	100.0%(36/36)	100.0%(36/36)	100.0%(108/108)	96.6%-100.0%
a One sample was positive for influenza A, but unexpectedly positive for SARS-CoV-2

Table 3. Summary of Reproducibility Results with the Visby Medical Respiratory
Health Test

Analytical Evaluation

Limit of Detection

The limit of detection (LoD) is the lowest concentration of viral nucleic acid that is reliably detected by the Visby Respiratory Health Test. Influenza A, influenza B, and SARS-CoV-2 were tested in a range-finding study of 3-fold dilutions in neqative clinical matrix, and the lowest concentration with 100% detection was established as the estimated LoD. The estimated LoD was confirmed by testing 20 replicates, where confirmation of the LoD was achieved when at least 19 of the 20 replicates returned a positive result for the virus tested. All viruses were tested individually in single-positive samples. The LoD of the Visby Medical Respiratory Health Test for influenza B, and SARS-CoV-2 are summarized in Table 4 below.

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Virus	LoD Concentration
Influenza A/H1N1 2009, Brisbane/02/18	106 copies/swab4.89 TCID50/swab
Influenza A/H3N2, Kansas/14/2017	125 copies/swab2.01 FFUa/swab
Influenza B/Washington/02/19	728 copies/swab9.20 TCID50/swab
Influenza B/Oklahoma/10/2018	778 copies/swab88.37 TCID50/swab
SARS-CoV-2 (USA-WA1/2020)	100 copies/swab

Table 4. Limit of Detection (LoD) for the Visby Medical Respiratory Health Test
Analytes

ª FFU: Fluorescent Focus Units. Titer by Fluorescent Focus Assay in MDCK-SIAT1 Cells.

WHO 1st International Standard for SARS-CoV-2

The established analytical sensitivity or LoD of the Visby Medical Respiratory Health Test when tested with the World Health Organization (WHO) 1st International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146) is 2.2 x 105 IU/mL of RNA in the sample tested.

Inclusivity

The ability of the Visby Medical Respiratory Health Test to detect 10 H1N1 (pandemic 2009) strains, 13 H3N2 strains, 12 influenza B strains (5 each of Victoria and Yamagata lineages and 2 additional strains), 6 SARS-CoV-2 strains, and 6 avian influenza A strains (RNA only, representing H5N1, H7N9, and H9N2). Each virus was individually spiked into negative clinical matrix at or near 3x LoD (unless otherwise noted) and tested in triplicate. All strains were successfully detected within 3x LoD, with the exception of the Omicron (BA.2.3) Isolate USA/MD-HP24556/2022 (detected at 6x LoD) and A/Egypt/321/2007 (H5N1).

Virus	Strain	TestedConcentration
Influenza A H1N1(pdm2009)	A/Brownsville/39H/2009	318 copies/swab
	A/Hong Kong/H090-761-V1(0)/2009	318 copies/swab
	A/Netherlands/2629/2009	318 copies/swab
	A/Massachusetts/15/2013	318 copies/swab
	A/Bangladesh/3002/2015	318 copies/swab
	A/Michigan/45/2015	318 copies/swab
	A/St. Petersburg/61/2015	318 copies/swab
	A/Hawaii/66/2019	318 copies/swab
	A/Wisconsin/588/2019	318 copies/swab
	A/Indiana/02/2020	318 copies/swab
Virus	Strain	TestedConcentration
Influenza A H3N2	A/Netherlands/22/2003	393 copies/swab
	A/New York/55/2004	393 copies/swab
	A/Brisbane/10/2007	393 copies/swab
	A/Uruguay/716/2007	393 copies/swab
	A/Hong Kong/H090-756-V1(0)/2009	393 copies/swab
	A/Perth/16/2009	393 copies/swab
	A/Victoria/361/2011	393 copies/swab
	A/Texas/50/2012	393 copies/swab
	A/Switzerland/9715293/2013	393 copies/swab
	A/Alaska/232/2015	393 copies/swab
	A/California/55/2020	393 copies/swab
	A/Hong Kong/2671/2019	393 copies/swab
	A/Wisconsin/04/2018	393 copies/swab
Avian Influenza A¹	A/duck/Hunan/795/2002 (H5N1)	1500 pg/mL
	A/chicken/Yunnan/1251/2003 (H5N1)	1500 pg/mL
	A/Vietnam/1194/2004 (H5N1)	1500 pg/mL
	A/Egypt/321/2007 (H5N1)	Not Detected²
	A/Anhui/1/2013 (H7N9)	1500 pg/mL
	A/chicken/Hong Kong/G9/1997 (H9N2)	1500 pg/mL
Influenza B	B/Lee/1940	2334 copies/swab
	B/Maryland/1/1959	2334 copies/swab
	B/Malaysia/2506/2004	2184 copies/swab
Influenza B VictoriaLineage	B/St. Petersburg/14/2006	2184 copies/swab
	B/Brisbane/60/2008	2184 copies/swab
	B/Nevada/03/2011	2184 copies/swab
	B/New Jersey/1/2012	2184 copies/swab
		B/New York/1061/2004
	B/Florida/4/2006	2334 copies/swab
Influenza BYamagata Lineage	B/Texas/06/2011	2334 copies/swab
	B/Phuket/3073/2013	2334 copies/swab
		B/Guangdong-Liwan/1133/2014
		Alpha (B.1.1.7) England/204820464/2020
		Beta (B.1.351) South Africa/ KRISP-K005325/2020
	Gamma (P.1) Japan/TY7-503/2021	300 copies/swab
SARS-CoV-2	Delta (B.1.617.2) USA/PHC658/2021	300 copies/swab
	Β.1.1.529 BA.1 Isolate: USA/MD-HP20874/2021	300 copies/swab
	Omicron (BA.2.3) Isolate: USA/MD-HP24556/2022	600 copies/swab
	¹ Purified RNA will be tested due to biosafety regulations.

Table 5. Analytical Reactivity (Inclusivity) of the Visby Respiratory Health Test

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2 The Visby Medical Respiratory Health Test returned influenza A positive results in 2/3 replicates at 1500 pg/mL for the A/Egypt/321/2007 (H5N1) strain RNA.

In silico analysis of sequences from GISAID are conducted routinely to assess the ability of the Visby Medical Respiratory Health Test to detect the most recent COVID-19 strains. The results of these analyses of 16,852,539 total sequences, as of August 2024, show that the Visby Medical Respiratory Health Test will detect all variants in circulation.

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Cross-Reactivity and Microbial Interference

The potential for cross-reactivity from microorganisms that may be found in an upper respiratory sample other than the target respiratory viruses (influenza A, influenza B, and SARS-CoV-2) on the performance of the Visby Medical Respiratory Health Test was evaluated. Forty-three (43) microorganisms were tested in triplicate at high concentrations (>105 units/mL for viruses and >106 units/mL for bacteria and yeast) in negative samples (negative clinical matrix). No cross-reactivity was observed with any of the organisms at the concentrations tested.

Microbial Interference was evaluated by testing the same 43 microorganisms in triplicate in negative clinical matrix in the presence of low concentrations of the target organisms (3X LoD for influenza A, influenza B, and SARS-CoV-2). No microbial interference was observed with any of the microorganisms at the concentrations tested.

Table 6. Microorganisms Evaluated for Cross-Reactivity and Microbial Interference on Visby Respiratory Health Test

Viruses (ATCC Number)	Bacteria and Yeast (ATCC Number)
Human Coronavirus 229E (VR-740)	Bordetella parapertussis (15311)
Human Coronavirus OC43 (VR-1558)	Bordetella pertussis (9340)
Human coronavirus HKU1 (VR-3262SD) *	Candida albicans (18804)
Human Coronavirus NL63 (VR-3263SD) *	Chlamydia pneumoniae (53592)
SARS-Coronavirus (VR-3280SD) *	Corynebacterium xerosis (373)
MERS-Coronavirus (VR-3248SD) *	Escherichia coli (25922)
Adenovirus strain 1, C1 Ad 71 (VR-1)	Haemophilus influenzae (49247)
Adenovirus strain 7 (VR-7)	Lactobacillus brevis (14869)
Cytomegalovirus (VR-977)	Legionella pneumophila (33152)
Epstein Barr virus (B95-8, ZeptoMetrix)	Moraxella (Branhamella) catarrhalis (25238)
Enterovirus 68 (NR-51430, BEI)	Mycobacterium tuberculosis (25177)
Human metapneumovirus (hMPV) (NR-22232, BEI)	Mycoplasma genitalium (49123)
Human parainfluenza virus 1 (NR-48681, BEI)	Mycoplasma pneumoniae (15531)
Human parainfluenza virus 2 (VR-92)	Neisseria meningitidis serogroup a (13077)
Human parainfluenza virus 3 (VR-93)	Neisseria mucosa (19695)
Human parainfluenza virus 4b (NR-3238, BEI)	Pneumocystis jirovecii also called Pneumocystis carinii Delanoe and Delanoe (PRA-159)
Measles (VR-24)	Pseudomonas aeruginosa (0801519, ZeptoMetrix)
Mumps (VR-106DQ) *	Staphylococcus aureus (12600)
Respiratory syncytial virus (Strain B) (VR-1400)	Staphylococcus epidermidis (12228)
Human rhinovirus 1A (strain 2060) (VR-1559)	Streptococcus pneumoniae (49619)
* Purified RNA was tested for these viruses.	Streptococcus pyogenes (19615)
	Streptococcus salivarius (9759)
	Pooled human nasal wash

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Competitive Interference

The potential for high concentrations of one target organism to interfere with detection of low concentrations of another target organism was evaluated. Influenza A, influenza B, and SARS-CoV-2 viruses were spiked into negative clinical matrix at varying concentrations and then tested in triplicate. Low concentrations were prepared at 3x LoD for the respective viruses, and high concentrations were prepared at ≥ 105 copies/swab. No competitive interference was observed for any of the three target viruses at the concentrations tested.

Viral Targets in Sample			Detection Rate (# Positive / # Tests)
Influenza A	Influenza B	SARS-CoV-2	Influenza A	Influenza B	SARS-CoV-2
High	Low	Neg	3/3	3/3	0/3
High	Neg	Low	3/3	0/3	3/3
Low	High	Neg	3/3	3/3	0/3
Neg	High	Low	0/3	3/3	3/3
Low	Neg	High	3/3	0/3	3/3
Neg	Low	High	0/3	3/3	3/3

Table 7. Competitive Interference for each Target Virus

Endogenous/Exogenous Interfering Substances

Potentially interfering substances that may be found in a clinical nasal sample were evaluated to determine if they interfere with the accuracy of test results. The potential interfering substances were spiked in negative clinical matrix and tested in the presence and absence of low concentrations (3x LoD) of influenza A, influenza B, and SARS-CoV-2 viruses. All samples were tested in triplicate. As shown in Table 8 below, all of the neqative samples returned valid results that were negative for influenza B, and SARS-CoV-2. All the positive samples returned valid results that were positive for influenza A, influenza B, and SARS-CoV-2. None of the tested substances were found to interfere with test accuracy at the concentrations tested.

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Substance	Concentration	Negative Samples(# Negative / # Tests)	Low Positive Samples(3x LoD)(# Positive / # Tests)
Afrin	25% (v/v)	3/3	3/3
Biotin	3.5 µg/mL	3/3	3/3
Flonase	25% (v/v)	3/3	3/3
Fresh Whole Blood PooledHuman Donors	5% (v/v)	3/3	3/3
Human lotion	5% (w/v)	3/3	3/3
Hand sanitizer	5% (w/v)	3/3	3/3
Purified mucin protein	1% (w/v)	3/3	3/3
Method all purpose cleaner	5% (v/v)	3/3	3/3
Mupirocin	12 mg/mL	3/3	3/3
Nasacort	25% (v/v)	3/3	3/3
Nasal Saline Spray	25% (v/v)	3/3	3/3
NeoSynephrine Cold & SinusExtra Strength Spray	25% (v/v)	3/3	3/3
Seventh generationdisinfectant	5% (v/v)	3/3	3/3
Softsoap moisturizing handsoap	5% (w/v)	3/3	3/3
Tobramycin	2.43 mg/mL	3/3	3/3
Zanamivir (Relenza)	5 mg/mL	3/3	3/3
Zicam Allergy Relief	25% (v/v)	3/3	3/3

Table 8. Potentially Interfering Substances

Specimen Stability

The stability of nasal swab specimens after elution into the Visby Respiratory Health Buffer was determined when stored at room temperature (15 - 30°C) or refrigerated (2 -8°C) conditions. Influenza A, influenza B, and SARS-CoV-2 viruses were spiked into neqative clinical matrix at 2x LoD and tested at baseline and at each storage time-point with 20 replicates. All low positive devices returned the expected triple positive results at all time-points tested. Based on the results, the following specimen stability in Visby Respiratory Health Buffer is claimed:

Room temperature (15 30°C) storage up to 120 minutes (2 hours) ●
Refrigerated (2 - 8°C) storage up to 48 hours (2 days)

H. Conclusions

The analytical and clinical studies have demonstrated that the Visby Medical Respiratory Health Test is substantially equivalent to the predicate device (K220963).

Regulation Number and Section

§ 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

(a)
Identification. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
e.g., BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
e.g., when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
e.g., saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
i.e., H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (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 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 influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza 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 labeling required under § 809.10(b) of this chapter that 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 accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.