đź“‹ FDA Reference
dcl syphilis-m catalog no 600-80
Diagnostic Chemicals, Ltd. (Usa)
Summary: The dcl syphilis-m is a diagnostic device used for detecting syphilis infections. It is typically used by healthcare professionals in laboratory settings to aid in the diagnosis of syphilis.
FDA Clearance Information
Pathway
510K
Number
K895964 ↗
Decision Date
January 8, 1991
Product Code
LIP
Device Class
Class 2
Evidence
419 studies
The dcl syphilis-m, manufactured by Diagnostic Chemicals, Ltd., received FDA clearance via the 510k pathway on January 8, 1991. It is classified as a Class 2 device under the product code LIP.
What It Is
The dcl syphilis-m is a diagnostic test designed to detect antibodies to the bacterium Treponema pallidum, the causative agent of syphilis. This device works by utilizing specific reagents that react with patient samples to indicate the presence of syphilis antibodies. It is an essential tool in the laboratory diagnosis of syphilis, providing clinicians with critical information for patient management.
Clinical Applications
This device is commonly used in clinical laboratories and public health settings to screen for syphilis, particularly in sexually transmitted infection (STI) clinics, hospitals, and community health centers. It is used by laboratory technicians and healthcare providers to confirm syphilis infection in patients who present with symptoms or have been identified as at risk through screening programs.
Indications for Use
The dcl syphilis-m is indicated for use in the detection of syphilis antibodies in human serum or plasma. It is used to diagnose syphilis in patients who may present with symptoms or are part of routine screening, especially in high-risk populations.
Practical Considerations
The device typically requires standard laboratory equipment for processing and analysis. Compatibility with other diagnostic systems should be verified, and proper training in handling and interpreting results is essential for accurate diagnosis. Regular calibration and maintenance of laboratory equipment are recommended to ensure reliability.
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
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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
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 dcl syphilis-m used for?
The dcl syphilis-m is used to detect antibodies to Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
This device is typically used in laboratory medicine, infectious disease, and public health specialties.
What are the FDA-cleared indications?
The device is cleared for the detection of syphilis antibodies in human serum or plasma, 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.