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immulite 2000 syphilis screen test system
Siemens Healthcare Diagnostics
Summary: The Immulite 2000 Syphilis Screen Test System is a diagnostic device used for syphilis screening. It is FDA-cleared and primarily used in clinical laboratories. Key evidence highlights its role in syphilis diagnosis using chemiluminescence immunoassay.
FDA Clearance Information
Pathway
510K
Number
K091361 ↗
Decision Date
December 16, 2009
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The Immulite 2000 Syphilis Screen Test System was cleared by the FDA through the 510(k) pathway on December 16, 2009. It is manufactured by Siemens Healthcare Diagnostics and is classified as a Class 2 device under product code LIP.
What It Is
The Immulite 2000 Syphilis Screen Test System is a diagnostic device that utilizes chemiluminescence immunoassay (CIA) technology for the detection of syphilis antibodies. It is intended for use in clinical laboratories to aid in the diagnosis of syphilis.
Clinical Applications
This device is commonly used in clinical settings for the initial screening of syphilis, particularly in laboratories that employ automated treponemal tests. It is part of syphilis screening algorithms that combine treponemal and nontreponemal tests.
Evidence Summary
The available literature includes two studies evaluating the efficacy of the Immulite 2000 Syphilis Screen Test System. These studies, published between 2011 and 2019, include retrospective and comparative analyses of syphilis screening methods.
Reported Outcomes
Published studies report that the Immulite 2000 Syphilis Screen Test System is effective in the serological diagnosis of syphilis when used as part of a screening algorithm. The studies highlight its role in improving diagnostic accuracy when combined with nontreponemal tests.
Safety Profile
Reported complications include limited efficacy when used alone without a nontreponemal test, as highlighted in the studies. No specific adverse events related to the device itself were reported in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some analyses. Further research is needed to evaluate long-term outcomes and the effectiveness of the device in diverse clinical settings.
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 are the clinical indications for Immulite 2000 Syphilis Screen Test System?
The device is indicated for the serological screening of syphilis in clinical laboratory settings.
What outcomes have been reported in clinical studies?
Studies report improved diagnostic accuracy in syphilis screening when the device is used in combination with nontreponemal tests.
What complications have been reported?
Reported complications include limited efficacy when used without a nontreponemal test, but no specific adverse events were noted.
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.