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cromatest syphilis diagnostic
Biotrax
Summary: The Cromatest Syphilis Diagnostic by Biotrax is a diagnostic tool used to detect syphilis infections. It is typically utilized by healthcare professionals in laboratories and clinical settings.
FDA Clearance Information
Pathway
510K
Number
K904496 ↗
Decision Date
July 24, 1991
Product Code
GMQ
Device Class
Class 2
Evidence
419 studies
The Cromatest Syphilis Diagnostic was cleared via the FDA 510k pathway on July 24, 1991. Manufactured by Biotrax, it is classified as a Class 2 device under product code GMQ.
What It Is
The Cromatest Syphilis Diagnostic is an in vitro diagnostic device designed to detect antibodies to Treponema pallidum, the bacterium that causes syphilis. It works by using antigen-antibody reactions to identify the presence of syphilis in a patient's blood sample. This test is crucial for early detection and management of syphilis, which can prevent complications associated with untreated infections.
Clinical Applications
This diagnostic device is commonly used in clinical laboratories and hospitals by pathologists and laboratory technicians. It is essential for screening and confirming syphilis in patients, particularly in sexually transmitted infection (STI) clinics, prenatal care settings, and public health programs. The test is vital for at-risk populations, including those with multiple sexual partners or individuals in areas with high syphilis prevalence.
Indications for Use
The FDA-cleared indications for the Cromatest Syphilis Diagnostic involve its use in detecting syphilis infections in patients. It is intended for individuals suspected of having syphilis or those undergoing routine STI screening.
Practical Considerations
The Cromatest Syphilis Diagnostic is typically compatible with standard laboratory equipment and requires trained personnel to perform the test accurately. Proper sample collection and handling are crucial to ensure reliable results. The device may come in various kit sizes to accommodate different testing volumes.
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 Cromatest Syphilis Diagnostic used for?
It is used to detect syphilis infections by identifying antibodies to Treponema pallidum in blood samples.
What specialties typically use this device?
Pathologists, laboratory technicians, and healthcare providers in STI clinics and public health settings commonly use this device.
What are the FDA-cleared indications?
The device is indicated for detecting syphilis in patients suspected of infection or undergoing routine STI screening.
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.