(340 days)
Syva MicroTrak® II Chlamydia EIA
Syva MicroTrak® II Chlamydia EIA
No
The summary describes a standard immunoassay system for detecting chlamydia antigen and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) immunoassay designed to detect chlamydia antigen, not to provide therapy or treatment.
Yes
The device is described as performing qualitative immunoassays for the detection of Chlamydia antigen, which is a diagnostic purpose. The performance metrics, such as sensitivity, specificity, PPV, and NPV, further confirm its diagnostic utility in identifying the presence of Chlamydia.
No
The device description explicitly states it is a "paramagneticparticle, chemiluminescent enzyme immunoassay" and uses the "ACCESS® Immunoassay System," indicating it is a hardware-based diagnostic system that utilizes reagents and instrumentation, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "direction of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens". This involves testing biological samples taken from the human body.
- Device Description: The description further clarifies it's a "qualitative, paramagneticparticle, chemiluminescent enzyme immunoassay". Immunoassays are a common type of in vitro diagnostic test.
- Anatomical Site: The specified anatomical sites (urethral, endocervical, urine) are all sources of biological specimens.
- Performance Studies and Key Metrics: The inclusion of performance studies with metrics like Sensitivity, Specificity, PPV, and NPV are standard for evaluating the accuracy of IVD devices.
- Predicate Device: The mention of a predicate device (Syva MicroTrak® II Chlamydia EIA) which is also an EIA for Chlamydia antigen, further confirms its classification as an IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Sanofi Diagnostics Pasteur Inc. ACCESS® Chlamvdia antigen are qualitative, paramagneticparticle, chemiluminescent enzyme immunoassays for the direction of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.
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
adult male urethral, female endocervical, and male urine specimens
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
In clinical studies, the ACCESS® Chlamydia was compared to culture or DFA on 2092 urogenital and 572 male urine specimens.
A comparison to the Syva MicroTrak® II Chlamydia EIA was done on 1518 urogenital and 303 male urine specimens. The concordance was 98.1% and 95.4%, respectively.
Representative data for within run and total precision are 4.2% and 11.9% for negative, 5.6% and 17.5% for low positive, and 3.6% and 21.1% for high positive specimens.
Key Metrics
| high risk females | 86% | 99.7% | 96% | 99% |
|---|---|---|---|---|
| low risk females | 100% | 100% | 100% | 100% |
| symptomatic males | 93% | 99.7% | 98% | 99% |
| symptomatic males urine | 88% | 99% | 94% | 98% |
| asymptomatic males | 88% | 100% | 100% | 99.5% |
| asymptomatic males urine | 56% | 100% | 100% | 98% |
Predicate Device(s)
Syva MicroTrak® II Chlamydia EIA
Reference Device(s)
Not Found
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).
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SANOFI DIAGNOSTICS PASTEUR, INC. 1000 LAKE HAZELTINE DRIVE CHASKA, MINNESOTA 55318-1084 U.S.A. TEL: (612) 448-4848
Image /page/0/Picture/2 description: The image shows the Sanofi Pasteur logo. The logo consists of two stacked rectangles. The top rectangle is white with the word "sanofi" in black, bold letters. The bottom rectangle is black with the word "Pasteur" in white, bold letters.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS February 29, 1996
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
Sanofi Diagnostics Pasteur, Inc.
1. General Information
Applicant's Name and Address:
| | 1000 Lake Hazeltine Drive
Chaska, MN 55318
(612)448-4848
Katia Breslawec | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|--|--|
| Device Classification Name: | Chlamydia Serological Reagents | | |
| Device Trade Name: | ACCESS® Chlamydia Reagents | | |
| 2. Predicate Device | Syva MicroTrak® II Chlamydia EIA
Syva Company
3403 Yerba Buena Road P.O. Box 4901
San Jose, CA 95161 | | |
3. Device Description
The Sanofi Diagnostics Pasteur Inc. ACCESS® Chlamvdia antigen are qualitative, paramagneticparticle, chemiluminescent enzyme immunoassays for the direction of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.
4. Summary of Studies
In clinical studies, the ACCESS® Chlamydia was compared to culture or DFA on 2092 urogenital and 572 male urine specimens. The respective sensitivity, specificity, PPV, and NPV by population category were:
| high risk females | 86% | 99.7% | 96% | 99% |
|---|---|---|---|---|
| low risk females | 100% | 100% | 100% | 100% |
| symptomatic males | 93% | 99.7% | 98% | 99% |
| symptomatic males urine | 88% | 99% | 94% | 98% |
| asymptomatic males | 88% | 100% | 100% | 99.5% |
| asymptomatic males urine | 56% | 100% | 100% | 98% |
A comparison to the Syva MicroTrak® II Chlamydia EIA was done on 1518 urogenital and 303 male urine specimens. The concordance was 98.1% and 95.4%, respectively.
Representative data for within run and total precision are 4.2% and 11.9% for negative, 5.6% and 17.5% for low positive, and 3.6% and 21.1% for high positive specimens.
ર. Conclusion
The Sanofi Diagnostics Pasteur ACCESS® Chlamydia is substantially equivalent to a standard laboratory reference method (cell culture) and to another kit currently in commercial distribution for the direction of chlamydia in adult female endocervical, male urethral, and male urine specimens.