IMAGEN RESPIRATORY SCREEN

K973954 · Dako Diagnostics , Ltd. · GNW · Dec 22, 1997 · Microbiology

Device Facts

• Record ID: K973954
• Device Name: IMAGEN RESPIRATORY SCREEN
• Applicant: Dako Diagnostics , Ltd.
• Product Code: GNW · Microbiology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

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.

Device Story

IMAGEN™ Respiratory Screen is an in vitro diagnostic test for the presumptive detection of respiratory viruses. It utilizes indirect immunofluorescence (IIF) technology to identify viral antigens in nasopharyngeal aspirates or cell cultures. The test is performed in a laboratory setting by qualified technicians. The procedure involves applying patient samples to slides, followed by the application of specific reagents and controls to ensure reliable results. The output is a visual fluorescence pattern observed via microscopy, which indicates the presence or absence of specific viral pathogens. This information assists clinicians in the microbiological diagnosis of respiratory infections. The device includes positive and negative control slides and a negative control reagent to validate test performance.

Clinical Evidence

Clinical performance was established by external evaluation comparing the IMAGEN™ Respiratory Screen against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods. No specific sensitivity, specificity, or p-values were provided in the summary document.

Technological Characteristics

Indirect immunofluorescence assay; utilizes specific reagents and control slides (positive/negative) for microbiological diagnosis. Designed for laboratory use by qualified technicians.

Indications for Use

Indicated for the qualitative presumptive detection of respiratory viruses (RSV, Influenza A and B, Parainfluenza types 1, 2, and 3, and Adenovirus) in nasopharyngeal aspirates and cell cultures. For use by qualified laboratory technicians.

Regulatory Classification

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.

Predicate Devices

• Bartels Viral Respiratory Screening and Identification Kit

Submission Summary (Full Text)

{0}------------------------------------------------

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[phone] Fax

Signature: Elisabeth She Date: 17th September 1997

E.A SILVER

{1}------------------------------------------------

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.

{2}------------------------------------------------

#### 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

{3}------------------------------------------------

## 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)

or

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