(216 days)
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No
The summary describes a traditional immunofluorescence assay and does not mention any AI or ML components.
No
Explanation: This device is a diagnostic test used to detect the presence of specific viruses, not to treat a medical condition.
Yes
The IMAGENTM Respiratory Screen is a qualitative indirect immunofluorescence test for the detection of specific viruses, indicating its use in identifying the presence of disease-causing agents, which is a diagnostic function.
No
The device description explicitly lists physical reagents (Screening reagent, Negative control reagent, FITC Conjugate reagent, Mounting fluid, Positive and Negative Control slides) and describes a two-step direct immunofluorescence staining method, indicating it is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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." This describes a test performed in vitro (outside the body) on biological specimens (respiratory specimens and cell culture) to diagnose or detect a condition (presence of specific viruses).
- Device Description: The description details reagents and a staining method used to perform the test on these specimens.
- Anatomical Site: It specifies "Respiratory specimens," which are biological samples taken from the body.
- Intended User / Care Setting: It mentions "Laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis," indicating a laboratory setting where diagnostic tests are performed.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMAGENTM 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The test consists of the following reagents:
- a Screening reagent; a pool of purified mouse monoclonal antibodies each of which has i) individual specificity for either Respiratory Synctial virus, Influenza A and B virus, Parainfluenza types 1,2 and 3 and Adenovirus.
- a Negative control reagent; pooled mouse monoclonal antibodies with no anti-viral ii) activity .
- a Fluorescein Isothiocyanate (FITC) Conjugate reagent; FITC conjugated F(ab')2 iii) fragment of rabbit anti-mouse immunoglobulins
- Mounting fluid; containing a photobleaching inhibitor in glycerol iv)
- Positive and Negative Control slides; fourteen well combined positive and negative v) 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).
IMAGENTM 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 IMAGENTM reagents.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Respiratory specimens
Indicated Patient Age Range
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Intended User / Care Setting
laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Synctial virus, Influenza A and B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus) in cell culture isolates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS ડ.
The IMAGENTM 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,
DEC 2 6 1996
- a Screening reagent; a pool of purified mouse monoclonal antibodies each of which has i) individual specificity for either Respiratory Synctial virus, Influenza A and B virus, Parainfluenza types 1,2 and 3 and Adenovirus.
- a Negative control reagent; pooled mouse monoclonal antibodies with no anti-viral ii) activity .
- a Fluorescein Isothiocyanate (FITC) Conjugate reagent; FITC conjugated F(ab')2 iii) fragment of rabbit anti-mouse immunoglobulins
- Mounting fluid; containing a photobleaching inhibitor in glycerol iv)
- Positive and Negative Control slides; fourteen well combined positive and negative v) 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).
IMAGENTM 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 IMAGENTM 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 Synctial virus, Influenza A and B virus, Parainfluenza virus types 1, 2 and 3 and Adenovirus) in cell culture isolates.
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IMAGENTM 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 IMAGENTM 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 n.2.
The product insert contains a list of safety and technical precautions which should be followed to ensure safe and effective use of the IMAGENTM 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 IMAGENTN 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 FTTC 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 Dr Elisabeth Johnson-Proctor, device. Please contact:
Head of Quality and Regulatory Affairs, DAKO Diagnostics Limited, Denmark House, Angel Drove, Ely, Cambridgeshire, CB7 4ET, UK. Fax (353) 668989 Phone (353) 669911
Signature: Elsbeth Jms-Port Date: 9 April 1996
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