đź“‹ FDA Reference
dcl - syphilis-g assay catalog no 600-70
Diagnostic Chemicals, Ltd. (Usa)
Summary: The dcl - syphilis-g assay is a diagnostic tool used to detect syphilis infections. It is primarily utilized by laboratory technicians and clinicians in infectious disease settings.
FDA Clearance Information
Pathway
510K
Number
K895965 ↗
Decision Date
December 26, 1990
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The dcl - syphilis-g assay was cleared through the FDA 510(k) pathway on December 26, 1990. It is manufactured by Diagnostic Chemicals, Ltd. and classified as a Class 2 device under product code LIP.
What It Is
The dcl - syphilis-g assay is a serological test designed to detect antibodies against the syphilis-causing bacterium, Treponema pallidum. It functions by identifying specific antibodies in the blood, indicating a current or past infection. This assay is crucial in diagnosing syphilis, a sexually transmitted infection that can cause serious health issues if left untreated.
Clinical Applications
This assay is commonly used in clinical laboratories for the screening and diagnosis of syphilis. It is particularly relevant in sexual health clinics, prenatal care settings, and infectious disease departments. The test is essential for early detection and management of syphilis, especially in pregnant women to prevent congenital syphilis in newborns.
Indications for Use
The FDA-cleared indications for this assay include the detection of syphilis infections in patients. It is used for screening individuals who may be at risk of syphilis, including those with symptoms or known exposure to the infection.
Practical Considerations
The dcl - syphilis-g assay is typically compatible with standard laboratory equipment used for serological testing. It requires proper handling of blood samples and adherence to laboratory protocols to ensure accurate results.
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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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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
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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 dcl - syphilis-g assay used for?
It is used for detecting antibodies against Treponema pallidum, the bacterium responsible for syphilis.
What specialties typically use this device?
Infectious disease specialists, laboratory technicians, and clinicians in sexual health and prenatal care settings.
What are the FDA-cleared indications?
The assay is indicated for the detection of syphilis infections in patients, aiding in diagnosis and management.
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.