Remel Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

Device Description

The Xpect® Flu A&B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample wells of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibodyantigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance

The provided text describes a 510(k) submission for a device modification (K092423) that expands the reactivity table of an existing device (Remel Xpect® Flu A&B, K031565). The core acceptance criteria revolve around analytical sensitivity, specifically the detection limits for various influenza strains.

Acceptance Criteria (Stated)	Reported Device Performance (Remel Xpect® Flu A&B - Additional Reactivity Claim)
Analytical Sensitivity: Detection of various influenza A and B strains at specified concentrations. The critical new addition for this 510(k) is the detection of A/California/04/2009 (H1N1) at a specified concentration.	Analytical Sensitivity: The device was tested against 16 influenza strains (10 influenza A and 6 influenza B) in a titration study to determine the positive endpoint. The key new data point relevant to this specific 510(k) (K092423) is the inclusion of the A/California/04/2009 (H1N1) strain with a detected limit of 4.41 x 10^2 TCID50/ml. Other key strains and their detection limits are provided in the "Summary of Performance Data" table within the text, for example: - A/New Caledonia/20/1999 (H1N1): 1.63 x 10^2 TCID50/ml - A/Fort Monmouth/1/47 (H1N1): 7.9 x 10^1 CEID50/ml - A/Hong Kong/8/68 (H3N2): 2.8 x 10^1 CEID50/ml - B/Allen/45 (B): 4 x 10^0 CEID50/ml
Intended Use: Rapid in vitro immunochromatographic test for direct, qualitative detection of influenza A and B viral antigens from nasal wash, nasal swab, and throat swab specimens from symptomatic patients, as an aid in rapid diagnosis. Negative tests should be confirmed by cell culture.	Intended Use: The intended use of the modified device has not changed from the predicate device and aligns with the acceptance criteria.
Fundamental Scientific Technology: No changes to the fundamental scientific technology.	Fundamental Scientific Technology: The submission explicitly states, "This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device." This was accepted by the reviewer.
Risk Assessment: Address risks of false positive and false negative results, with mitigation through labeling, training, QC, and confirmation of negative results.	Risk Assessment: The study indicates that "The risks of false positive and false negative test results as related to the risks to patients, were addressed with labeling, appropriate training for users, customer quality control and confirmation of all negative results by cell culture."

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

Sample Size (Test Set): For the analytical sensitivity study (which serves as the primary test set for this modification), the study used 16 influenza strains (10 influenza A and 6 influenza B). Each strain was quantitated and subjected to serial titration to determine the detection limit. This is a laboratory-based analytical study, not a clinical study with patient samples.
Data Provenance: The data is from a retrospective analytical study conducted in a laboratory setting. There is no information provided about the country of origin of the data beyond the applicant "Thermo Fisher Scientific Remel Products" being based in Lenexa, KS, USA, implying the study was conducted internally or contracted within the US. The strains themselves are named with geographic locations (e.g., A/California/04/2009, A/Puerto Rico/8/34), but this refers to the strain's isolation origin, not the origin of the study data.

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

Number of Experts: Not applicable. For this analytical sensitivity study, the "ground truth" for each virus strain's concentration (TCID50/ml or CEID50/ml) would have been established through standardized laboratory methods (e.g., cell culture titration) rather than expert consensus on individual test results.
Qualifications of Experts: Not applicable. The "ground truth" for viral concentration is determined by quantitative assay rather than human interpretation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This was an analytical study determining the detection limit of viral strains. The endpoint was reached when a positive result was consistently observed, implying a clear, objective assessment rather than a need for adjudicated interpretations of ambiguous results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission specifically addresses an analytical modification (expanded reactivity) and not a change in the device's human-in-the-loop performance or clinical utility compared to human readers.
Effect Size: Not applicable as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the analytical sensitivity study is a standalone performance assessment. The device (Remel Xpect® Flu A&B) is an immunochromatographic test, meaning it produces a visual result (a line) directly. The analytical sensitivity study determined the lowest concentration of virus the device could detect on its own, without human interpretation adding to or detracting from its direct reactivity.

7. The Type of Ground Truth Used

Type of Ground Truth: For the analytical sensitivity study, the ground truth was quantitated viral concentration (expressed as TCID50/ml or CEID50/ml). This is a laboratory-based quantitative measurement of infectious virus particles, which is highly objective.

8. The Sample Size for the Training Set

Sample Size (Training Set): The document does not provide a specific sample size for a "training set." This is because the device is a rapid in vitro diagnostic (IVD) immunoassay, not a machine learning or AI-driven device that typically undergoes a training phase. Its performance relies on the biochemical interactions of antigens and antibodies. The "training" in this context would be the initial development and optimization of the assay's reagents and format, for which specific sample sizes are not typically reported in such regulatory summaries.

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

Ground Truth (Training Set): As mentioned above, there isn't a traditional "training set" in the context of an AI/ML device. For an immunochromatographic assay like the Xpect® Flu A&B, the optimization and development would involve:
- Selection and characterization of antibodies: Ensuring high specificity and affinity for influenza A and B nucleoproteins.
- Optimization of reagent concentrations: Determining the ideal amounts of conjugated antibodies, capture antibodies, and other components for optimal signal-to-noise ratio and sensitivity.
- Optimization of membrane characteristics and flow properties.
- Ground truth during this development phase would be established by testing against a range of known positive (cultured virus, clinical samples confirmed by cell culture or RT-PCR) and negative samples (other respiratory viruses, healthy controls) to refine the assay parameters. Quantitative viral loads (TCID50/ml or CEID50/ml) would likely have been used as the internal ground truth during these developmental stages to guide improvements in detection limits.

Summary

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510(k) SUMMARY

AUG 2 6 2009

XO92423

Contact Information: Mary Ann Silvius Director, New Product & Business Development Microbiology North America Thermo Fisher Scientific Remel Products 12076 Santa Fe Drive Lenexa, KS 66215 Phone: (913) 895-4054 Fax: (913) 895-4054 email: msilvius@thermofisher.com

August 6, 2009 Date Prepared:

Remel Xpect® Flu A&B Device Trade Name:

Remel Xpect® Flu A&B (K031565; S&E July 17, 2003) Predicate Device:

21 CFR 866.3330: Influenza virus serological reagents. Device Classification:

Xpect® -A&B is a rapid in vitro Flu Intended Use: Remel immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

The Xpect® Flu A&B is a chromatographic immunoassay for the Device Description: qualitative detection of influenza A and influenza B viral The test device incorporates separate membrane antigens. strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample wells of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibodyantigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

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510(k) Summary Cont.

Device Comparison:

Characteristic	Remel Xpect Flu A&BPredicate	Remel Xpect Flu A&BAdditional AnalyticalSensitivity
Intended Use	Remel Xpect® Flu A&B is a rapid in vitroimmunochromatographic test for thedirect, qualitative detection of influenza Aand influenza B viral antigens(nucleoprotein) from nasal wash, nasalswab, and throat swab specimens fromsymptomatic patients. The test is intendedas an aid in the rapid diagnosis ofinfluenza A and influenza B viralinfections. Negative tests should beconfirmed by cell culture.	Remel Xpect® Flu A&B is a rapid in vitroimmunochromatographic test for thedirect, qualitative detection of influenza Aand influenza B viral antigens(nucleoprotein) from nasal wash, nasalswab, and throat swab specimens fromsymptomatic patients. The test is intendedas an aid in the rapid diagnosis ofinfluenza A and influenza B viralinfections. Negative tests should beconfirmed by cell culture.
Sample	Qualitative; Influenza A and B viralantigens with differentiation.	Qualitative; Influenza A and B viralantigens with differentiation.
Test Methodology	Immunochromatographic membraneassay	Immunochromatographic membraneassay
Specimen Type	Nasal wash, nasal swab, and throat swabspecimens	Nasal wash, nasal swab, and throat swabspecimens

Summary of Performance Data:

Analytical Sensitivity:

The analytical sensitivity was evaluated using 16 influenza strains; 10 influenza A and 6 influenza B. Each viral strain was quantitated and titrated until a positive endpoint was reached using the Xpect® Flu A&B test. The amount of virus at the endpoint dilution, expressed per test, was calculated as a measure of analytical sensitivity.

Influenza Strain	Type	Detection Limit
		TCID50/ml
A/California/04/2009	A (H1N1)	$4.41 x 10^2$
A/New Caledonia/20/1999	A (H1N1)	$1.63 x 10^2$
		CEID50/ml
A/Puerto Rico/8/34	A (H1N1)	$8.9 x 10^3$
A/Fort Monmouth/1/47	A (H1N1)	$7.9 x 10^1$
A/New Jersey/8/76	A (H1N1)	$8.9 x 10^1$
A/Hong Kong/8/68	A (H3N2)	$2.8 x 10^1$
A/Victoria/3/75	A (H3N2)	$8.9 x 10^2$
A/Port Chalmers/1/73	A (H3N2)	$4.0 x 10^1$
A/BhGoose/QH/1/05	A (H5N1)	$2.0 x 10^4$
A/Chicken/WD/98	A (H9N2)	$3.16 x 10^3$
B/Lee/40	B	$7.9 x 10^3$
B/Allen/45	B	$4 x 10^0$
B/Maryland/1/59	B	$6 x 10^0$
B/GL/1739/54	B	$8.9 x 10^1$
B/Taiwan/2/62	B	$3 x 10^0$
B/Hong Kong/5/72	B	$1.58 x 10^2$

TCID – 50% tissue culture infectious dose; CEID – 50% chicken embryo infectious dose

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510(k) Summary Cont.

Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) virus Allifough this test has been shown the performance characteristics of this device with human specimens infected with the 2009 H1N1 influenza virus have not been established. The Xpecif Flu A&B test can distinguish between influenza A and B viruses, but it does not rrie Apor - 1.6 Aug too ena A virus from the novel influenza A (2009 H1N1) virus and the ulliteremiate seasonal midonza i Pirao with the novel influenza A 2009 H1N1 virus in clinical specimens is unknown.

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SPECIAL 510(k): Device Modification OIVD Review Memorandum (Decision Making Document is Attached)

RE: THE FILE DOCUMENT NUMBER K092423 To:

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

The name and 510(k) number of the SUBMITTER'S previously cleared device: 1. Remel Xpect Flu A&B Test - K031565.
Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in 2. its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.
The modification of the device consisted of expanded reactivity table to include reactivity information 3. for 2009 H1N1 Influenza strain A/California/04/2009. This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

Parameter	DeviceAdditional Reactivity Claim RemelXpect Flu A&B	PredicateRemel Xpect Flu A&B510(k) Number K031565
INTENDED USE	Remel Xpect® Flu A&B is a rapid invitro immunochromatographic test forthe direct, qualitative detection ofinfluenza A and influenza B viralantigens (nucleoprotein) from nasalwash, nasal swab, and throat swabspecimens from symptomatic patients.The test is intended as an aid in therapid diagnosis of influenza A andinfluenza B viral infections. Negativetests should be confirmed by cellculture.	Same
ANALYTE	Differentiated detection of influenza A& B nucleoprotein antigens	Same
TECHNOLOGY	Lateral flow immunochromatographicmembrane assay	Same
SPECIMEN TYPE	Nasal wash, nasal swab, and throatswab specimens.	Same
ANALYTICALSENSITIVITY	Ten A strains (four H1N1, one 2009H1N1-swine lineage, three H3N2, oneH5N1, one H9N2) and six B strains.	Eight A strains (three H1N1,three H3N2, one H5N1, oneH9N2) and six B strains.

Comparison Information (similarities and differences): ব

5. Design Control Activities Summary

a) Sponsor provided a signed statement that:
- All verification and validation activities were performed by the designated individual(s) and the i) results demonstrated that the predetermined acceptance criteria were met, and
- ii) The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

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b) The method used for the Risk Analysis for the Xpect Flu A&B Test was Failure Mode Effects Analysis (FEMA). This risk analysis method provides an effective way to assess the impact of the modification on the device and its components. Potential failures are identified in terms of failure modes. For each mode, the effect on the total system is then evaluated.
c) The effects of the common biological and environmental IVD device risks were addresses with labeling.
d) The risks of false positive and false negative test results as related to the risks to patients, were addressed with labeling, appropriate training for users, customer quality control and confirmation of all negative results by cell culture.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified devices demonstrate that the fundamental scientific technology has not changed. I recommend the device be determined substantially equivalent to the previously cleared device.

Melanie Alushred

(Reviewer's Signature)

11-5-09

(Date)

revised:8/1/03

Comments

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

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	Yes	No
1. Same Indication Statement?	X		If YES = Go To 3
2. Do Differences Alter The Effect Or Raise New Issues ofSafety Or Effectiveness?		X	If YES = Stop NSE
3. Same Technological Characteristics?	X		If YES = Go To 5
4. Could The New Characteristics Affect Safety OrEffectiveness?		X	If YES = Go To 6
5. Descriptive Characteristics Precise Enough?	X		If NO = Go To 8If YES = Stop SE
6. New Types Of Safety Or Effectiveness Questions?		X	If YES = Stop NSE
7. Accepted Scientific Methods Exist?	X		If NO = Stop NSE
8. Performance Data Available?	X		If NO = Request Data
9. Data Demonstrate Equivalence?	X		Final Decision: SE

Note: See

http://eroom.fda.gov/eRoomReg/Files/CDRH3/CDRHPremarketNotification510kProgram/0 4148/FLOWCHART%20 DECISION%20TREE%20.DOC for Flowchart to assist in decision-making process. Please complete the following table and answer the corresponding questions. "Yes" responses to questions 2, 4, 6, and 9, and every "no" response requires an explanation.

1. Explain how the new indication differs from the predicate device's indication: There is no difference in the indications for use.
1. Explain why there is or is not a new effect or safety or effectiveness issue: There is no change to the indications for use and there are no new concerns of risk raised with this modification.
1. Describe the new technological characteristics: There has been no change to the technological characteristics of the device.
Explain how new characteristics could or could not affect safety or effectiveness: 4. The added analytical reactivity information does not affectiveness of the device; limitation of test is provided in the labeling.
1. Explain how descriptive characteristics are not precise enough: Provided information is sufficiently descriptive.
Explain new types of safety or effectiveness question(s) raised or why the question(s) are not new: 6. There are no new types of safety or effectiveness questions raised.
1. Explain why existing scientific methods can not be used: The added analytical reactivity information was derived using existing scientific methods.
1. Explain what performance data is needed: No additional performance data are needed.
ਰੇ. Explain how the performance data demonstrates that the device is or is not substantially equivalent:

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4 — K092423

で、

The added analytical reactivity information does not change the performance of the device with clinical samples.

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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of the caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the seal. The caduceus is rendered in blue.

JAN - 4 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mary Ann Silvius Director of New Product & Business Development Microbiology North America Thermo Fisher Scientific Remel Products 12076 Santa Fe Drive Lenexa, KS 66215 Attn: Mary Ann Silvius

Re: K092423

Trade/Device Name: Remel Xpect Flu A&B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: August 6, 2009 Received: August 7, 2009

Dear Ms. Silvius:

This letter corrects our substantially equivalent letter of August 26, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mary Ann Silvius

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Souza Atyr

Sally A. Hoivat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K092423

Device Name: Xpect® Flu A&B

Xpect® Use: Indications For Flu A&B is a rapid in Remel vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092423

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.