📋 FDA Reference
Ortho Syphilis-M Antibody Elisa Test
Ortho Diagnostic Systems
Summary: The Ortho Syphilis-M Antibody ELISA Test is a diagnostic tool used to detect antibodies against syphilis. It is primarily used by laboratory technicians and clinicians in diagnostic laboratories.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K883938 ↗
Decision Date ?
December 22, 1988
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Ortho Syphilis-M Antibody ELISA Test was cleared through the FDA 510k pathway on December 22, 1988. Manufactured by Ortho Diagnostic Systems, it is classified as a Class 2 medical device.
What It Is
The Ortho Syphilis-M Antibody ELISA Test is an enzyme-linked immunosorbent assay designed to detect antibodies to Treponema pallidum, the bacterium that causes syphilis. This test uses specific antigens to capture and quantify antibodies present in a patient's serum, providing a reliable diagnosis of syphilis infection. It is a crucial tool in the early detection and management of syphilis, aiding in timely treatment and prevention of disease transmission.
FDA-Cleared Indications
- Detection of antibodies to Treponema pallidum in human serum.
- Use in individuals suspected of having syphilis.
- Use as part of screening for syphilis in populations at risk, according to the product labeling.
Clinical Applications
- Laboratory testing of serum from patients suspected of having syphilis.
- Syphilis screening in at-risk populations.
- Syphilis testing in prenatal screening programs when ordered under applicable clinical protocols.
- Testing performed in sexually transmitted infection clinics and other diagnostic laboratory settings.
Practical Considerations
- The assay requires a properly collected and handled human serum specimen.
- Testing should be performed with compatible ELISA laboratory equipment and according to the manufacturer's instructions.
- A reactive antibody result indicates serologic evidence of exposure or infection but should be interpreted with the patient's history, examination, and other syphilis tests.
- Cross-reactivity and antibodies from previous treponemal infection may affect interpretation; confirmatory or supplemental testing may be needed.
- This is an in vitro laboratory assay, not an implanted or wearable device; MRI safety, device sizing, and vascular compatibility do not apply.
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 the Ortho Syphilis-M Antibody ELISA Test used for?
It is used to detect antibodies against Treponema pallidum, the bacterium that causes syphilis.
What specialties typically use this device?
Laboratory technicians and clinicians in diagnostic laboratories, STI clinics, and prenatal care settings.
What are the FDA-cleared indications?
The test is indicated for detecting syphilis antibodies in individuals suspected of having syphilis or in routine screening of at-risk populations.
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.