(301 days)
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No
The summary describes a fully automated enzyme-linked fluorescent immunoassay (ELFA) and does not mention any AI or ML components.
No
The device is used to verify positive and equivocal results from specimens in a Chlamydia assay, indicating it is a diagnostic tool, not for treating a condition.
Yes
The device is used to "verify positive and equivocal results" and for "qualitative detection of Chlamydia antigen," which directly relates to diagnosing a condition.
No
The device description explicitly states it is a "fully automated enzyme-linked fluorescent immunoassay (ELFA)" and requires the addition of "blocking and reference reagents" to "VIDAS Chlamydia strips." This indicates a physical assay with reagents and strips, 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 used to "verify positive and equivocal results from female endocervical and male urtheral specimens" in another assay (VIDAS Chlamydia (CHL) assay). This involves testing biological specimens in vitro (outside the body) to provide information about a patient's health status (presence of Chlamydia antigen).
- Device Description: The description details an "enzyme-linked fluorescent immunoassay (ELFA)," which is a common laboratory technique used for in vitro diagnostic testing.
- Anatomical Site: The specimens are taken from specific anatomical sites (female endocervical and male urethral), indicating the analysis of biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The VIDAS Chlamydia Blocking (CHB) assay used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.
Product codes
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Device Description
The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips.
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
female endocervical and male urtheral
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
The data comparing the performance of the VIDAS Chlamydia Blocking assay to that of cell culture can be found in Section 8 of this submittal.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).
0
OCT - 7 1996
SECTION 7 Summary of Substantial Equivalence
The VIDAS Chlamydia Blocking (CHB) assay used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.
Major similarities include:
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- Both the VIDAS Chlamydia Blocking assay and cell culture detect the presence of viable chlamydial antigens in patient specimens.
Major differences include:
- Both the VIDAS Chlamydia Blocking assay and cell culture detect the presence of viable chlamydial antigens in patient specimens.
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- Standard cell culture only detects viable antigen in female and male swab specimens. The VIDAS Chlamydia Blocking assay detects both viable and nonviable antigen in female and male swab specimens.
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- The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips. Standard cell culture methodologies are labor intensive and requires confirmation by Giemsa, iodine, or fluorescent antibody staining.
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- Along with the VIDAS Chlamydia assay results for the VIDAS Chalmydia Blocking assay can be obtained within 2 1/2 hours. Cell culture methodologies require at least 48 hours to obtain results.
The data comparing the performance of the VIDAS Chlamydia Blocking assay to that of cell culture can be found in Section 8 of this submittal.