(479 days)
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No
The device description details a chemical reaction that produces a color change, which is then filtered and observed. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies compare the device's results to standard laboratory methods (IFA), not to the output of an AI/ML model.
No
Explanation: The device is a screening test for identifying the presence of influenza and parainfluenza viruses in respiratory viral cultures and does not provide any therapeutic benefit or treatment.
Yes
The device is intended for use as a screening test for respiratory viral cultures to detect the presence of influenza and parainfluenza viruses, which directly aids in identifying a disease state.
No
The device description clearly outlines a chemical reaction involving a chromogenic substrate, diazonium salt, and a filter device to produce a visible color change. This indicates a physical, in-vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4." This indicates it's used to examine specimens (culture fluids) in vitro to provide information about a patient's potential infection.
- Device Description: The description details a chemical reaction that occurs in vitro (in the culture fluid) to detect the presence of viral neuraminidase. This is a characteristic of an in vitro diagnostic test.
- Anatomical Site: While the sample originates from a patient's respiratory system, the test is performed on "respiratory viral cultures," which are prepared in vitro.
- Performance Studies: The performance studies involve testing "previously identified patient specimens" and comparing the results to a "standard culture confirmation with monoclonal antibodies." This is typical of the validation process for an IVD.
The device is designed to be used outside of the body to examine a specimen (culture fluid) to aid in the diagnosis or screening of influenza and parainfluenza infections. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza is intended for use as a screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4. This test will screen culture fluids for the presence of these viruses, but it is not indented for the definitive typing of these viruses.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Influenza and parainfluenza viruses posses surface glycoproteins with neuraminidase activity, that hydrolyze substrates which contain alphaketosidically linked N-acetylneuraminic acid (Neu5Ac). A modified Neu5Ac molecule has been synthesized and coupled to a chromogen to produce the neuraminidase substrate. In the presence of influenza and parainfluenza the chromogenic substrate is then cleaved by the action of viral neuraminidase, releasing a free chromogen. This free chromogen is then precipitated by combining with a diazonium salt to produce a red color. The red precipitate is then concentrated and collected from the solution onto a filter device.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Viral studies were performed using the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza at four separate locations throughout the United States. These studies compared the ViraZyme® Culture Confirmation Screen results to results obtained from standard culture confirmation with monoclonal antibodies.
At a Southern medical center, 177 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 98/177 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 98, ViraZyme® was positive in 100% (23/23) of influenza A IFA confirmed positives, 100% (22/22) of influenza B IFA confirmed positives, 94.4% (17/18) of parainfluenza 1 IFA confirmed positives, 100% (8/8) parainfluenza 2 IFA confirmed positives, and 63.4% (26/41) of parainfluenza 3 IFA confirmed positives. The test site reported two virus-negative specimens by IFA as appearing weakly positive in ViraZyme®. The reminder of the specimens were IFA-negative specimens and these were all negative in ViraZyme®.
At a Southwestern medical center, 97 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 37/97 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 37, ViraZyme® was positive in 100% (36/36) of influenza A IFA confirmed positive and 1.9% (1/53) of Parainfluenza 3 IFA confirmed. The remainder of the specimens at this site were virus-negative by positives. IFA and likewise negative in ViraZyme®. The low ViraZyme® sensitivity for parainfluenza 3 at this site is believed to be related to the presence of bovine serum in the feed medium used at this site.
At a Midwestern medical center, 123 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 62/123 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 62, ViraZyme® was positive in 100% (11/11) of influenza A IFA confirmed positives, 100% (16/16) of influenza B IFA confirmed positives, 100% (5/5) of parainfluenza 1 IFA confirmed positives, 77.8% (7/9) of parainfluenza 2 IFA confirmed positives and 55.6% (5/9) of parainfluenza 3 IFA confirmed positives. Eighteen specimens, which were originally identified as virus positive by IFA at the time of isolation from the patient as being influenza A (five), parainfluenza 1 (four) and parainfluenza 3 (nine), were ViraZyme®-positive, but IFA negative, when tested for these same viruses. The remainder of the specimens were virus-negative by IFA and appropriately negative in ViraZyme®.
In an in-house evaluation, in the Southwest, a total of 403 previously identified frozen as well as fresh patient specimens were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 185/403 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 185, ViraZyme® was positive in 100% (49/49) of influenza A IFA confirmed positives. 100% (99/99) of influenza B IFA confirmed positives, 85.7% (12/14) of parainfluenza 1 IFA confirmed positives, 100% (7/7) of parainfluenza 2 IFA confirmed positives, and 77.8% (14/18) of parainfluenza 3 IFA confirmed positives. Two other ViraZyme®-positives were IFA confirmed for parainfluenza 4 along with two additional ViraZyme®-positives which were mumps virus strains. Mumps, being the other human virus, besides the influenza and parainfluenzas to produce neuraminidase, gave predictably positive in ViraZyme® as well as by IFA confirming MAb. The reminder of the specimens were IFA-negative for influenza and parainfluenza and these were also all negative in ViraZyme®.
Numerous lots of uninoculated Primary Rhesus Monkey Kidney were also included as negative culture controls to establish that there was no indication of false positive ViraZyme® results associated with either the cells or breakthrough endogenous simian virus. ViraZyme® was shown to be negative in all of these culture controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key results listed within the Summary of Performance Studies (above). Specific metrics like Sensitivity, Specificity, PPV, NPV are not explicitly presented as separate metrics.
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.
0
JUN 17 1996
Appendix C Safety and Effectiveness Summary for ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza
This information is provided as a summary of the safety and effectiveness of the ZymeTx, ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza Viruses. For more detailed information please refer to the product package insert.
The ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza is intended for use as a screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4. This test will screen culture fluids for the presence of these viruses, but it is not indented for the definitive typing of these viruses.
Influenza and parainfluenza viruses posses surface glycoproteins with neuraminidase activity, that hydrolyze substrates which contain alphaketosidically linked N-acetylneuraminic acid (Neu5Ac). A modified Neu5Ac molecule has been synthesized and coupled to a chromogen to produce the neuraminidase substrate. In the presence of influenza and parainfluenza the chromogenic substrate is then cleaved by the action of viral neuraminidase, releasing a free chromogen. This free chromogen is then precipitated by combining with a diazonium salt to produce a red color. The red precipitate is then concentrated and collected from the solution onto a filter device.
Performance Characteristics
Viral studies were performed using the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza at four separate locations throughout the United States. These studies compared the ViraZyme® Culture Confirmation Screen results to results obtained from standard culture confirmation with monoclonal antibodies.
At a Southern medical center, 177 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 98/177 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 98, ViraZyme® was positive in 100% (23/23) of influenza A IFA confirmed positives, 100% (22/22) of influenza B IFA confirmed positives, 94.4% (17/18) of parainfluenza 1 IFA confirmed positives, 100% (8/8) parainfluenza 2 IFA confirmed positives, and 63.4% (26/41) of parainfluenza 3 IFA confirmed positives. The test site reported two virus-negative specimens by IFA as appearing weakly positive in ViraZyme®. The reminder of the specimens were IFA-negative specimens and these were all negative in ViraZyme®.
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At a Southwestern medical center, 97 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 37/97 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 37, ViraZyme® was positive in 100% (36/36) of influenza A IFA confirmed positive and 1.9% (1/53) of Parainfluenza 3 IFA confirmed The remainder of the specimens at this site were virus-negative by positives. IFA and likewise negative in ViraZyme®.
The low ViraZyme® sensitivity for parainfluenza 3 at this site is believed to be related to the presence of bovine serum in the feed medium used at this site. This site routinely used a commercial medium containing 2% bovine serum to feed the inoculated PRMK cultures. It has been shown, in our in-house studies that presence of serum at this concentration will result in a reduced ViraZyme® result. It has been observed that parainfluenza 3 typically gives a lower ViraZyme® result relative to a typical influenza result. Due to the results of our own in-house evaluation with serum and those seen at this test site, we have defined the ViraZyme® culture procedure to exclude serum from virus culture medium.
At a Midwestern medical center, 123 previously identified patient specimens from freeze were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 62/123 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 62, ViraZyme® was positive in 100% (11/11) of influenza A IFA confirmed positives, 100% (16/16) of influenza B IFA confirmed positives, 100% (5/5) of parainfluenza 1 IFA confirmed positives, 77.8% (7/9) of parainfluenza 2 IFA confirmed positives and 55.6% (5/9) of parainfluenza 3 IFA confirmed positives. Eighteen specimens, which were originally identified as virus positive by IFA at the time of isolation from the patient as being influenza A (five), parainfluenza 1 (four) and parainfluenza 3 (nine), were ViraZyme®-positive, but IFA negative, when tested for these same viruses. The remainder of the specimens were virus-negative by IFA and appropriately negative in ViraZyme®
In an in-house evaluation, in the Southwest, a total of 403 previously identified frozen as well as fresh patient specimens were examined in the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza. A total of 185/403 specimens were positive in the ViraZyme® Culture Confirmation Screen. Of these 185, ViraZyme® was positive in 100% (49/49) of influenza A IFA confirmed positives.
100% (99/99) of influenza B IFA confirmed positives, 85.7% (12/14) of parainfluenza 1 IFA confirmed positives, 100% (7/7) of parainfluenza 2 IFA confirmed positives, and 77.8% (14/18) of parainfluenza 3 IFA confirmed positives. Two other ViraZyme®-positives were IFA confirmed for parainfluenza 4 along with two additional ViraZyme®-positives which were
2
Appendix C - Safety and Effectiveness Summary for ViraZyme ® Culture Confirmation Screen for Influenza and Parafinfluenza
mumps virus strains. Mumps, being the other human virus, besides the influenza and parainfluenzas to produce neuraminidase, gave predictably positive in ViraZyme® as well as by IFA confirming MAb. The reminder of the specimens were IFA-negative for influenza and parainfluenza and these were also all negative in ViraZyme®.
Numerous lots of uninoculated Primary Rhesus Monkey Kidney were also included as negative culture controls to establish that there was no indication of false positive ViraZyme® results associated with either the cells or breakthrough endogenous simian virus. ViraZyme® was shown to be negative in all of these culture controls.
Technical Information
For technical information and comments regarding this product, you may contact the ViraZyme® Product Manager at (405) 271-1383.
This Safety and Effectiveness Summary has been provided as a part of the 510(k) notification for the ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza.
Craig A. Schmoele
Craig D. Shimasaki Executive Director of Research
8/23/95
Date