đź“‹ FDA Reference
Syphilis Bio-Enzabead Kit
Biometics Laboratory Products
Summary: The Syphilis Bio-EnzaBead Kit is an FDA-cleared diagnostic tool used to detect treponemal antibodies in patients suspected of having syphilis. It is primarily used by laboratory professionals in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K820934 ↗
Decision Date ?
June 10, 1982
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The Syphilis Bio-EnzaBead Kit was cleared through the FDA 510(k) pathway on June 10, 1982. Manufactured by Biometics Laboratory Products, it is classified as a Class 2 device under product code LIP.
What It Is
The Syphilis Bio-EnzaBead Kit is an enzyme-linked immunosorbent assay (ELISA) designed to detect antibodies against Treponema pallidum, the bacterium responsible for syphilis. This diagnostic kit uses a bead-based format to capture and identify specific antibodies in patient serum samples, providing a reliable method for confirming syphilis infection.
FDA-Cleared Indications
- Detection of treponemal antibodies in serum from patients suspected of having syphilis.
- Use as an in vitro diagnostic test in clinical laboratory settings to aid in the diagnosis of syphilis infection.
Clinical Applications
- Serologic testing of patients with suspected syphilis infection.
- Laboratory evaluation of serum for antibodies to Treponema pallidum.
- Testing in infectious disease and sexual health laboratory settings when syphilis is part of the diagnostic evaluation.
- Use by trained laboratory personnel with standard equipment for the assay procedure.
Practical Considerations
- The kit is intended for serum specimens and requires standard laboratory equipment and trained personnel for the assay procedure.
- Reagents must be handled and stored according to the manufacturer’s labeling to preserve test performance.
- Results should be interpreted with the patient’s clinical history and other syphilis testing because treponemal antibodies may persist after prior infection and treatment.
- This is an in vitro diagnostic laboratory kit, not an implantable or therapeutic device; MRI compatibility and device sizing do not apply.
- A reactive result does not by itself establish active untreated infection; confirmatory and nontreponemal testing may be needed according to current clinical protocols.
Related Literature
The linked study evaluated the Syphilis Bio-EnzaBead Kit's performance in detecting treponemal antibodies compared to the standard fluorescent treponemal antibody absorption test. The study involved 600 specimens, demonstrating the kit's reliability in identifying syphilis infection. However, the study's limitations include its reliance on historical samples and the need for further validation in diverse populations.
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 Syphilis Bio-EnzaBead Kit used for?
It is used for detecting treponemal antibodies in patients suspected of having syphilis.
What specialties typically use this device?
Infectious disease specialists, laboratory technicians, and sexual health clinicians typically use this device.
What are the FDA-cleared indications?
The kit is indicated for detecting treponemal antibodies in patients suspected of syphilis infection, aiding in diagnosis.
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.