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Captia R Syphilis M Modification
Mercia Diagnostics
Summary: The Captia R Syphilis M Modification is a diagnostic device used for the detection of syphilis antibodies. It is primarily used by laboratory professionals in clinical settings to aid in the diagnosis of syphilis infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K904524 ↗
Decision Date ?
December 26, 1990
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Captia R Syphilis M Modification was cleared through the FDA 510(k) pathway on December 26, 1990. It is manufactured by Mercia Diagnostics and is classified as a Class 2 device under product code LIP.
What It Is
The Captia R Syphilis M Modification is a serological test designed to detect antibodies to Treponema pallidum, the bacterium responsible for syphilis. This test is typically performed in a laboratory setting and involves the use of specific reagents to identify the presence of syphilis antibodies in a patient's blood sample. The results can help clinicians confirm a diagnosis of syphilis, guiding appropriate treatment decisions.
FDA-Cleared Indications
- Detection of antibodies to Treponema pallidum in human blood specimens.
- Use as an in vitro diagnostic test to aid in the evaluation of patients for syphilis infection.
Clinical Applications
- Laboratory testing of patients with suspected syphilis infection.
- Testing of individuals with possible exposure to Treponema pallidum.
- Serologic evaluation performed in hospitals, public health laboratories, and sexual health clinics.
- Testing performed as part of a clinician-directed syphilis evaluation, including in pregnancy when syphilis screening is indicated.
Practical Considerations
- This is an in vitro laboratory test, not an implantable or therapeutic device.
- Use the specimen type, collection method, storage conditions, reagents, controls, and interpretation criteria specified in the manufacturer's instructions.
- Testing should be performed by trained laboratory personnel using compatible laboratory equipment.
- A reactive antibody result does not by itself establish the stage or activity of syphilis; clinicians may need additional treponemal and nontreponemal testing and clinical correlation.
- The test has no MRI, implant-size, or vascular-access considerations because it is not placed in the body.
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 Captia R Syphilis M Modification used for?
It is used for detecting antibodies to Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Laboratory professionals in clinical settings, including hospitals and public health clinics, typically use this device.
What are the FDA-cleared indications?
It is indicated for detecting antibodies to the syphilis-causing bacterium in patients suspected of having syphilis or at risk of exposure.
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.