IMAGEN RESPIRATORY SCREEN

K962037 · Dako Diagnostics , Ltd. · GNW · Dec 26, 1996 · Microbiology

Device Facts

• Record ID: K962037
• Device Name: IMAGEN RESPIRATORY SCREEN
• Applicant: Dako Diagnostics , Ltd.
• Product Code: GNW · Microbiology
• Decision Date: Dec 26, 1996
• 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 test for the detection of Respiratory Syncytial Virus, Influenza A virus, Parainfluenza virus type 3 and Adenovirus directly in respiratory specimens and Respiratory Syncytial Virus, Influenza A and B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus in cell culture monolayers. IMAGEN™ Respiratory Screen is intended for use in laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis.

Device Story

IMAGEN™ Respiratory Screen is an in vitro diagnostic test for respiratory viruses. Input: respiratory specimens or cell culture monolayers. Principle: two-step direct immunofluorescence staining. Process: screening reagent (pool of mouse monoclonal antibodies) binds to viral antigens; FITC-conjugated rabbit anti-mouse immunoglobulin detects bound antibodies. Output: fluorescence signal visualized by technician via microscopy. Used in clinical laboratories by qualified technicians. Results aid in microbiological diagnosis of viral respiratory infections. Benefits: enables specific identification of viral pathogens to guide clinical management.

Clinical Evidence

Performance established via external clinical evaluation comparing IMAGEN™ to Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation methods. Data supports identification of RSV, Influenza A, Parainfluenza 3, and Adenovirus in direct respiratory specimens. Data supports identification of all seven viruses (RSV, Influenza A/B, Parainfluenza 1/2/3, Adenovirus) in cell culture isolates. Cross-reactivity evaluated.

Technological Characteristics

Indirect immunofluorescence assay. Reagents: mouse monoclonal antibodies, FITC-conjugated rabbit anti-mouse immunoglobulins, mounting fluid with photobleaching inhibitor. Controls: acetone-fixed positive/negative control slides. Detection principle: fluorescence microscopy. Reagents contain 15mmol/L sodium azide and Evans blue dye.

Indications for Use

Indicated for qualitative detection of RSV, Influenza A, Parainfluenza 3, and Adenovirus in respiratory specimens, and RSV, Influenza A/B, Parainfluenza 1/2/3, and Adenovirus in cell culture monolayers. 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)

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5. SUMMARY OF SAFETY AND EFFECTIVENESS DEC 26 1996 K962037

The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence test for the detection of Respiratory Syncytial Virus, Influenza A virus, Parainfluenza virus type 3 and Adenovirus directly in respiratory specimens and Respiratory Syncytial Virus, Influenza A and B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus in cell culture monolayers. The test consists of the following reagents,

i) a Screening reagent; a pool of purified mouse monoclonal antibodies each of which has individual specificity for either Respiratory Syncytial virus, Influenza A and B virus, Parainfluenza types 1,2 and 3 and Adenovirus.

ii) a Negative control reagent; pooled mouse monoclonal antibodies with no anti-viral activity.

iii) a Fluorescein Isothiocyanate (FITC) Conjugate reagent; FITC conjugated F(ab')₂ fragment of rabbit anti-mouse immunoglobulins

iv) Mounting fluid; containing a photobleaching inhibitor in glycerol

v) Positive and Negative Control slides; fourteen well combined positive and negative control slides. Each slide consists of seven wells containing acetone-fixed cells infected with either RSV, Influenza A or B virus, Parainfluenza virus type 1, 2 or 3 or Adenovirus (one well specific for each virus) and seven wells containing acetone fixed uninfected cells (negative control wells).

IMAGEN™ Respiratory Screen is a two-step direct immunofluorescence staining method. The Screening reagent utilises a pool of mouse monoclonal antibodies to bind specifically to either Respiratory Syncytial Virus, Influenza A or B virus, Parainfluenza virus types 1, 2 or 3 or Adenovirus. The FITC conjugate reagent is used to detect any Screening reagent antibody which has bound to virus present in the respiratory specimen or cell culture monolayer. The Negative control reagent contains mouse monoclonal antibodies with no reactivity with any viral antigen or any antigen likely to be present in a respiratory specimen and is used to monitor the specificity of the stain. The respiratory virus present can be specifically identified using individual IMAGEN™ reagents.

Performance characteristics 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 F) and by evaluation of cross-reactivity (Exhibit G). Currently sufficient data has only been collected to establish claims for the identification of Respiratory Syncytial virus, Influenza A virus, Parainfluenza virus type 3 and Adenovirus directly in respiratory specimens. Trials are ongoing to collect adequate data to establish the outstanding claims for Influenza B virus and Parainfluenza virus types 1 and 2 for direct specimen testing. Data is submitted to support claims for the identification of all seven viruses (Respiratory Syncytial virus, Influenza A and B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus) in cell culture isolates.

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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 Technical Services phone number are provided to aid the user in further trouble-shooting.

The 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.

The product insert contains a list of safety and technical precautions which should be followed to ensure safe and effective use of the IMAGEN™ Respiratory Screen diagnostic test. This includes advice on handling and disposal of clinical specimens as though potentially infectious. Suggested precautions include the wearing of disposable gloves when handling clinical specimens and infected cells and washing of hands immediately after completion of the test. In addition the test should be carried out in a designated work area where eating, drinking, smoking, preparation and storage of food and application of cosmetics are not carried out. Materials should not be pipetted by mouth.

The following safety information about reagents is given in the Directions for Use:-

The IMAGEN™ Respiratory Screen reagents contain 15mmol/L sodium azide which is a POISON. Sodium azide may react with copper and lead plumbing systems to form explosive metal azides. Always dispose of azide-containing materials by washing with large quantities of water.

Evans blue dye is present in the FITC reagent. This may be carcinogenic and contact with the skin should be avoided

Care should be taken when using the mounting fluid as it may cause skin irritation. Skin should be flushed with water if contact occurs.

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 Johnson-Proctor,
Head of Quality and Regulatory Affairs,
DAKO Diagnostics Limited, Denmark House,
Angel Drove, Ely,
Cambridgeshire, CB7 4ET, UK.
Phone [phone]
Fax [phone]

Signature: Elisabeth Johnson-Proctor
Date: 9 April 1996