📋 FDA Reference
Tolvidine Red Unheated Serum Syphillis Card Test
Pre
Summary: The Tolvidine Red Unheated Serum Syphilis Card Test is a diagnostic tool used to detect syphilis in serum samples. It is primarily used by clinicians in laboratory settings to aid in the diagnosis of syphilis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K852751 ↗
Decision Date ?
August 20, 1985
Product Code ?
GMQ
Device Class ?
Class 2
Evidence ?
419 studies
The Tolvidine Red Unheated Serum Syphilis Card Test was cleared through the FDA 510(k) pathway on August 20, 1985. It is manufactured by Pre and classified as a Class 2 device under product code GMQ.
What It Is
The Tolvidine Red Unheated Serum Syphilis Card Test is a serological test designed to detect syphilis antibodies in unheated serum samples. It utilizes toluidine red dye to visually indicate the presence of antibodies, providing a quick and efficient diagnostic tool for syphilis. This test is particularly useful in settings where rapid screening is necessary, such as in public health clinics or during prenatal care.
FDA-Cleared Indications
- To aid in the diagnosis of syphilis by detecting syphilis-associated antibodies in serum.
- For testing unheated serum specimens according to the manufacturer's instructions.
Clinical Applications
- Laboratory evaluation of patients suspected of having syphilis.
- Serologic screening in clinical or public health laboratory workflows.
- Testing serum specimens collected during evaluation for suspected sexually transmitted infection.
- Use as part of a syphilis diagnostic algorithm, with reactive results interpreted alongside clinical findings and confirmatory testing.
Practical Considerations
- The test requires an appropriate unheated serum specimen; collection, handling, storage and testing should follow the manufacturer's instructions.
- A reactive or nonreactive result should not be interpreted in isolation. Clinical findings and additional syphilis serology may be needed to establish or exclude infection.
- This is a laboratory diagnostic test, not a device implanted in the body and not a treatment for syphilis.
- The record does not identify a device size, catheter specification, MRI classification or implantable component; MRI safety labeling is therefore not applicable.
- Performance can be affected by specimen quality, timing of infection, prior treatment and biologic or analytical factors.
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 Tolvidine Red Unheated Serum Syphilis Card Test used for?
It is used to detect syphilis antibodies in serum samples, aiding in the diagnosis of syphilis.
What specialties typically use this device?
This test is commonly used in laboratory medicine, public health, and infectious disease specialties.
What are the FDA-cleared indications?
The test is indicated for detecting syphilis antibodies in serum to aid in diagnosing syphilis.
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.