đź“‹ FDA Reference
Polychaco Fia-Abs Test for Syphilis
Parasitic Disease Consultants
Summary: The Polychaco FIA-ABS Test for Syphilis is a diagnostic tool used to detect syphilis antibodies in patients. It is primarily used by clinicians in infectious disease and sexual health clinics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831296 ↗
Decision Date ?
July 26, 1983
Product Code ?
JWL
Device Class ?
Class 2
Evidence ?
419 studies
The Polychaco FIA-ABS Test for Syphilis was cleared through the FDA 510(k) pathway on July 26, 1983. It is manufactured by Parasitic Disease Consultants and is classified as a Class 2 device.
What It Is
The Polychaco FIA-ABS Test for Syphilis is a fluorescent antibody test designed to detect antibodies against Treponema pallidum, the bacterium responsible for syphilis. This test uses indirect immunofluorescence to identify the presence of specific antibodies in the patient's serum. It is a confirmatory test often used following initial screening tests for syphilis.
FDA-Cleared Indications
- Detection of antibodies to Treponema pallidum in human serum.
- Use in patients suspected of having syphilis infection.
- Confirmation of suspected syphilis after a reactive screening test.
Clinical Applications
- Confirming suspected syphilis infection after a reactive RPR or VDRL result.
- Supporting the laboratory evaluation of patients with clinical findings suggestive of syphilis.
- Testing serum samples in hospital, infectious disease, sexual health, or reference laboratories.
Practical Considerations
- The test uses a serum sample and is performed in a laboratory; it is not an implanted or interventional device.
- Accurate results depend on proper blood collection, serum preparation, storage, and handling according to the laboratory instructions.
- Results should be interpreted with the patient's symptoms, examination findings, medical history, and other syphilis tests.
- A positive antibody result may reflect current or previous infection and does not by itself determine disease activity or treatment response.
- The test has no MRI restrictions, device dimensions, or vascular compatibility requirements because it is an in vitro diagnostic assay.
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 Polychaco FIA-ABS Test for Syphilis used for?
It is used to confirm the presence of syphilis antibodies in patients suspected of having a syphilis infection.
What specialties typically use this device?
Infectious disease specialists, dermatologists, and general practitioners in sexual health clinics commonly use this test.
What are the FDA-cleared indications?
The test is indicated for detecting syphilis antibodies in patients with suspected syphilis infection, especially following positive screening tests.
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.