đź“‹ FDA Reference
Captia R Syphilis-M
Mercia Diagnostics
Summary: The Captia R Syphilis-M is a diagnostic test used to detect syphilis antibodies. It is primarily used by clinicians in laboratories to aid in the diagnosis of syphilis infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K871548 ↗
Decision Date ?
August 7, 1987
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Captia R Syphilis-M was cleared through the FDA 510(k) pathway on August 7, 1987. Manufactured by Mercia Diagnostics, it is classified as a Class 2 device under product code LIP.
What It Is
The Captia R Syphilis-M is a serological test designed to detect antibodies specific to Treponema pallidum, the bacterium responsible for syphilis. It operates as an enzyme immunoassay (EIA), providing qualitative results that help in diagnosing active or past syphilis infections. This test is crucial in clinical settings for early detection and management of syphilis, especially in prenatal screening and high-risk populations.
FDA-Cleared Indications
- Detection of antibodies to Treponema pallidum in human serum or plasma.
- Use as an aid in the diagnosis of syphilis infection.
- Use with appropriate clinical and laboratory findings; the assay does not by itself distinguish active infection from previously treated or past infection.
Clinical Applications
- Laboratory testing of serum or plasma from patients suspected of having syphilis.
- Syphilis screening in clinical laboratory settings.
- Syphilis testing as part of prenatal screening programs.
- Testing in public health and sexually transmitted infection clinics when syphilis is suspected or screening is indicated.
Practical Considerations
- The test uses human serum or plasma specimens and requires appropriate collection, transport, storage, and handling.
- It is an enzyme immunoassay intended for use with compatible laboratory equipment, calibration procedures, and quality-control materials.
- A reactive antibody result may reflect current, past, or treated infection and generally requires interpretation with a nontreponemal test, confirmatory testing, symptoms, and treatment history.
- This is an in vitro diagnostic laboratory assay, not an implanted or patient-worn device; MRI safety, device sizing, and vascular compatibility do not apply.
- Specimen or procedural errors, inadequate controls, and testing outside the manufacturer’s instructions can produce unreliable 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
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 used for?
It is used to detect antibodies to Treponema pallidum, aiding in the diagnosis of syphilis.
What specialties typically use this device?
Infectious disease specialists, laboratory technicians, and public health professionals commonly use this test.
What are the FDA-cleared indications?
The device is indicated for detecting syphilis antibodies to diagnose syphilis in suspected patients.
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.