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Enzy-Well Syphilis Igg Model 91106
Diesse Diagnostica Senese S.P.A.
Summary: The Enzy-Well Syphilis IgG Model 91106 is a diagnostic device used to detect IgG antibodies for syphilis. It is primarily used by laboratory technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050590 ↗
Decision Date ?
August 10, 2006
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Enzy-Well Syphilis IgG Model 91106 was cleared through the FDA 510(k) pathway on August 10, 2006. It is manufactured by Diesse Diagnostica Senese S.P.A. and classified as a Class 2 device under product code LIP.
What It Is
The Enzy-Well Syphilis IgG Model 91106 is an enzyme immunoassay designed to qualitatively detect IgG antibodies against Treponema pallidum, the bacterium responsible for syphilis. This device functions by using a microplate format where patient serum is added, and the presence of antibodies is indicated by a color change. It is an essential tool for diagnosing syphilis, especially in cases where early detection is crucial for treatment and prevention of transmission.
FDA-Cleared Indications
- Qualitative detection of IgG antibodies to Treponema pallidum in human serum.
- Use as an aid in the diagnosis of syphilis.
Clinical Applications
- Laboratory testing of serum from patients suspected of having syphilis.
- Serologic evaluation as part of a laboratory workup for syphilis.
- Testing performed in clinical laboratories using enzyme immunoassay equipment and procedures.
Practical Considerations
- This is an in vitro diagnostic assay, not an implantable or therapeutic device.
- The test uses a microplate enzyme immunoassay format and requires compatible laboratory equipment, reagents, controls and calibrated procedures.
- Results should be interpreted with the patient's history, examination and other syphilis serology; a reactive antibody result does not by itself establish disease stage or activity.
- Users should follow the manufacturer's instructions for specimen handling, reagent storage, incubation times, washing and result interpretation.
- It is not an MRI device and has no MRI safety designation.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Enzy-Well Syphilis IgG Model 91106 used for?
It is used to detect IgG antibodies against Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Clinical pathologists and laboratory technicians in hospital and public health laboratory settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for the detection of IgG antibodies to Treponema pallidum in human serum, aiding in the diagnosis of syphilis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.