The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence screening test for the presumptive detection of respiratory viruses; Respiratory Syncytial Virus (RSV). Influenza A and B. Parainfluenza types 1. 2 and 3 and Adenovirus in respiratory specimens (nasopharyngeal aspirates) and in cell cultures.

Device Description

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AI/ML Overview

Here's an analysis of the provided text regarding the IMAGEN™ Respiratory Screen, structured according to your requested information:

IMAGEN™ Respiratory Screen Acceptance Criteria and Study Details

The provided documents (K973954) consist of a summary of safety and effectiveness, the FDA's clearance letter, and the Indications for Use statement for the IMAGEN™ Respiratory Screen. It is a supplement to K962037.

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state numerical acceptance criteria in a table format, nor does it provide detailed performance metrics (like sensitivity, specificity, accuracy) for the IMAGEN™ Respiratory Screen. Instead, it states that "Performance characteristics for the additional intended uses have been established by external clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods."

To fill this table accurately, we would need to refer to "Exhibit E," which is mentioned as containing the detailed performance data. Without "Exhibit E," specific numerical acceptance criteria and reported device performance cannot be provided.

Hypothetical Table (Illustrative, as actual data is missing from the provided text):

Performance Metric	Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical)
Sensitivity	≥ 90% for all target viruses	Not Reported (Refer to Exhibit E)
Specificity	≥ 95% for all target viruses	Not Reported (Refer to Exhibit E)
Overall Agreement	≥ 92% with reference methods	Not Reported (Refer to Exhibit E)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in the provided documents. The text mentions "clinical evaluation," but the number of specimens tested is not given.
Data Provenance: The study was an "external clinical evaluation." The specific country of origin for the data is not mentioned. Given the regulatory contact is from the UK, it's possible some or all of the clinical evaluation was conducted there or in other European countries, but this is not confirmed. It is a retrospective evaluation, as the data was collected to establish performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The ground truth for the test set was established using "standard viral isolation reference methods" and the "Bartels Viral Respiratory Screening and Identification Kit." These methods are considered the gold standard for viral detection.
The text does not specify the number of individual experts or their qualifications involved in interpreting these reference methods for establishing ground truth. The implication is that the reference methods themselves (e.g., viral culture followed by identification) are the "experts" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The provided text does not describe any specific adjudication method among human readers for the test set. Since the evaluation was against "standard viral isolation reference methods" and a predicate device (Bartels Kit), the ground truth was inherently established by these objective methods rather than through expert consensus requiring adjudication.

5. 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 study was not done. This device is an in vitro diagnostic (IVD) immunofluorescence screening test, not an AI-powered diagnostic tool. The performance description focuses on the agreement of the device's output with reference methods, not on human-reader performance with or without AI assistance.
Therefore, an effect size for human readers with/without AI assistance is not applicable and not reported.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was done. The IMAGEN™ Respiratory Screen itself is an "algorithm only" in the sense that it produces a result (presumptive detection of respiratory viruses) based on the immunofluorescence reaction. The "clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods" directly assesses the standalone performance of the IMAGEN™ system. The text indicates it's for use in laboratories where "qualified technicians are familiar with routine indirect immunofluorescence testing," suggesting that while human technicians perform the test, the performance being evaluated is that of the assay itself compared to the gold standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was "standard viral isolation reference methods" (e.g., cell culture with subsequent viral identification) and comparison against a legally marketed predicate device, the "Bartels Viral Respiratory Screening and Identification Kit." Viral isolation is considered a gold standard for detecting viable viruses. These are objective laboratory methods, not subjective expert consensus or pathology.

8. The sample size for the training set

The provided documents do not mention a "training set" or its sample size. This is consistent with the nature of an immunofluorescence assay development, which typically undergoes analytical validation and then clinical validation against known specimens rather than learning from a "training set" like an AI model would.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of an immunofluorescence assay, this question is not applicable. The development process for such a device would involve extensive internal validation using characterized specimens, but it's not typically referred to as a "training set" with ground truth established in the same way as machine learning models.

Summary

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7473454

ITEM 2

DEC 22 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

The proposed changes to the intended use of IMAGEN™ Respiratory Screen outlined n this supplementary information have no effect on the safety and effectiveness of the IMAGENTM Respiratory Screen product, as outlined in the original submission.

Performance characteristics for the additional intended uses have been established by external clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods used for screening for the presence of respiratory viruses. (Exhibit E)

IMAGEN™ Respiratory Screen is intended for use in laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis. However specific quality control information regarding the validity of test results is included in the Product Insert, to facilitate reliable and reproducible results and minimise the occurrence of false positive or false negative results. Procedures include the use of positive and negative control slides, a negative control reagent and specifications for acceptable results. Technical references and a Customer Services phone number are provided to aid the user in further troubleshooting.

IMAGEN™ Respiratory Screen is similar in use and technology to Bartel's Viral Respiratory Screening and Identification Kit, which is already in commercial distribution in the U.S.

Further information regarding the safety and effectiveness of IMAGEN™ Respiratory Screen will be made available within 30 days of request by any person. This information excludes confidential patient information and proprietary manufacturing procedures pertinent to this device. Please contact:

Dr Elisabeth Silver, Requlatory Affairs Manager, DAKO Limited, Denmark House, Angel Drove. Elv. Cambridgeshire, CB7 4ET, UK.

Phone(353) 669911 Fax

Signature: Elisabeth She Date: 17th September 1997

E.A SILVER

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 1997

Elisabeth A. Silver, Ph.D. Regulatory Affairs Manager DAKO Diagnostics Ltd. Denmark House Angel Drove, Elv Cambridgeshire CB7 4ET England, United Kingdom

Re: K973954

Trade Name: IMAGEN™ Respiratory Screen Regulatory Class: I Product Code: GNW Dated: September 22, 1997 Received: October 9, 1997

Dear Dr. Silver:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ITEM 5

INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number: Supplement to K962037

IMAGEN™ RESPIRATORY SCREEN Device Name:

Indications for Use: The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence screening test for the presumptive detection of respiratory viruses; Respiratory Syncytial Virus (RSV). Influenza A and B. Parainfluenza tvpes 1. 2 and 3 and Adenovirus in respiratory specimens (nasopharyngeal aspirates) and in cell cultures.

Signature: Elisabeth Silva

Date: Ith September 1997

E A SILVER, Ph.D. Regulatory Affairs Manager

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

.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

John Ticehurst 12/19/97
John Ticehurst MT
Interim Chief, Microbiology Branch

Prescription Use V (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 866.3330 Influenza virus serological reagents.

(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.