(520 days)
Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit
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No
The device description and performance studies describe a standard ELISA immunoassay for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond reading absorbance values.
No.
This device is an in vitro diagnostic (IVD) test used to detect antibodies, which helps diagnose a condition, but it is not used to treat or prevent a disease.
Yes
The device is an "immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum," which is indicative of its use in identifying infection. The description states it "may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum," directly linking it to the diagnosis of syphilis. Furthermore, its classification for "in vitro diagnostic use only" explicitly defines its diagnostic purpose.
No
The device description clearly outlines a laboratory-based immunoassay (ELISA) kit, which involves physical reagents, microplates, and a spectrophotometer for reading absorbance. This is a hardware-dependent in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
- Device Description: The description details a method for detecting antibodies in human serum/plasma, which are biological samples taken from the body and tested in vitro (outside the body).
- Testing of Human Samples: The performance studies describe testing human serum samples from various patient groups.
These points clearly indicate that the device is intended for diagnostic testing performed on biological samples in vitro.
N/A
Intended Use / Indications for Use
- For in vitro diagnostic use only. 1.
- ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the 2. qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique.
- The test may be used in conjunction with non-treponemal testing to provide 3. serological evidence of infection with T. pallidum.
Product codes
LIP
Device Description
ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum/ plasma. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum.
Mentions image processing
Not Found
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
A total of 525 samples were collected and tested to study the performance of the ENZY-WELL SYPHILIS laG kit.
FIRST group: 125 serum samples from both pediatric and adult male and female patients with syphilis.
SECOND group: 300 negative sera; 150 of these serum samples came from clinical sources and/or from a blood donor facility and 150 samples from normal donors.
THIRD group: 100 samples from subjects with no known history or serological evidence of syphilis and suspected for different kinds of infective or clinical pathology.
Summary of Performance Studies
Comparison studies, precision studies, interference and specificity studies, expected values were performed.
Performance was evaluated at Azienda Ospedaliera Umberto I (Ancona).
CLINICAL SAMPLE CORRELATION: A total of 525 samples were collected and tested.
First group (125 syphilitic sera): no disagreement between two comparative testing methods. The reference method FTA-ABS was not used.
Second group (300 syphilis-negative sera): one sample not in agreement. It was equivocal with ENZY-WELL SYPHILIS IgG and negative with CAPTIA Syphilis - G. The confirmatory FTA-ABS test was negative (also negative with TPHA and VDRL test).
Percent agreement positive = 100 %. 95% CI: 100%
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
Attachment no.5 to the December 9,2005 Letter
AUG 1 0 2006
Page 119
Appendix C
510(k) Summary of Safety and Effectiveness
| Name | DIESSE Diagnostica Senese SpA | |
|---|---|---|
| Address | Via delle Rose 10, 53035 Monteriggioni | |
| SI | ||
| Tel. 39-0577-587111 | ||
| Fax 39-0577-318690 | ||
| Contact Person | Dr. Francesco Cocola | |
| Phone Number | 39-0577-587143 | |
| Fax Number | 39-0577-318379 |
The Following section is included as required by the Safe Medical Device Act (SMDA) 1990. 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned 510(k) Number is: K050590 Applicant
| Date
| Prepared | February 4, 2004 |
|---|---|
| Name | DIESSE Diagnostica Senese SpA |
| Address | Via delle Rose 10, 53035 Monteriggioni SI, Italy |
| Tel. 011-39-0577- 587111 | |
| Fax 011-39-0577-318690 | |
| Contact | |
| Person | Dr. Francesco Cocola |
| Phone | |
| Number | 39-0577-587143 |
| Fax Number | 39-0577-318379 |
Device information
| Trade Name | ENZY-WELL SYPHILIS IgG |
|---|---|
| Classification | |
| Name | Enzyme linked immunosorbent assay, Treponema pallidum |
| Equivalent Device |
Equivalent Device
Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit
Device Description
ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum/ plasma. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum.
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Principle of the assay
The ENZY-WELL SYPHILIS IgG test is based on the ELISA technique (Enzyme-linked immunosorbent assay). Diluted patient sample is incubated in microplate wells coated with T. pallidum. During this incubation specific immunoglobulins, if present, bind to the antigen on the well. After washing, to eliminate unbound proteins, a second incubation is performed with the conjugate, composed of human IgG monoclonal antibodies labeled with peroxidase. After washing to remove unbound conjugate from the wells, the substrate is added, which will react to produce color in the presence of the peroxidase. An acidic solution is added to stop the reaction and the absorbance of the developed color is read at 450 nm
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| 3/9 |
Performance Characteristic
Comparison studies, precision studies, interference and specificity studies, expected values were performed. Performance was evaluated at Azienda Ospedaliera Umberto I (Ancona).
CLINICAL SAMPLE CORRELATION
A total of 525 samples were collected and tested to study the performance of the ENZY-WELL SYPHILIS laG kit.
FIRST group: 125 serum samples from both pediatric and adult male and female patients with syphilis.
SECOND group: 300 negative sera; 150 of these serum samples came from clinical sources and/or from a blood donor facility and 150 samples from normal donors.
THIRD group: 100 samples from subjects with no known history or serological evidence of syphilis and suspected for different kinds of infective or clinical pathology.
In the first group of the 125 syphilitic sera there was no disagreement between two comparative testing methods; therefore the reference method FTA-ABS was not used. In the second group of the 300 syphilis-negative sera there was one sample not in agreement. It was equivocal with the ENZY-WELL SYPHILIS IgG test and negative with the CAPTIA Syphilis - G test. The confirmatory FTA-ABS test was negative (it was also negative with TPHA and VDRL test).
Table n°1
Results obtained with ENZYWELL vs. Captia Syphills-G, testing 127(First Group ) Syphilitic sera:
| CAPTIA Syphilis - G | ||||
|---|---|---|---|---|
| Negative | Equivocal | Positive | ||
| ENZY- | ||||
| WEL | ||||
| SYPHI | ||||
| LIS IgG | Negative | 0 | 0 | 0 |
| Equivocal | 0 | 0 | 0 | |
| Positive | 0 | 0 | 125 |
Results:
Percent agreement positive = 100 %. 95% CI: 100%