📋 FDA Reference
Stanbio Syphilis Rpr Test No 1170
Stanbio Laboratory
Summary: The Stanbio Syphilis RPR Test No 1170 is a diagnostic tool used for the detection of syphilis. It is primarily used by laboratory technicians and healthcare providers in clinical settings to screen for syphilis infection.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K880144 ↗
Decision Date ?
May 23, 1988
Product Code ?
GMQ
Device Class ?
Class 2
Evidence ?
419 studies
The Stanbio Syphilis RPR Test No 1170 was cleared through the FDA 510(k) pathway on May 23, 1988. It is manufactured by Stanbio Laboratory and is classified as a Class 2 device under product code GMQ.
What It Is
The Stanbio Syphilis RPR Test No 1170 is a rapid plasma reagin (RPR) test used to detect non-treponemal antibodies in the blood, indicative of a syphilis infection. The test involves mixing a patient's serum or plasma with a reagent containing carbon particles. If antibodies are present, they cause the particles to clump, indicating a positive result. This test is commonly used for initial syphilis screening due to its simplicity and rapid results.
FDA-Cleared Indications
- Qualitative detection of reagin antibodies in human serum or plasma.
- Screening individuals for possible syphilis infection.
Clinical Applications
- Initial laboratory screening for syphilis.
- Testing patients with signs or symptoms that may be associated with syphilis.
- Screening people at increased risk for sexually transmitted infections.
- Syphilis screening in prenatal care when indicated by clinical or public health protocols.
- Public health and clinical laboratory testing of serum or plasma specimens.
Practical Considerations
- The test uses human serum or plasma and requires trained laboratory personnel and appropriate specimen handling.
- The assay is a nontreponemal screening test; reactive results generally require confirmation with a treponemal-specific test according to the laboratory's diagnostic algorithm.
- A reactive result does not by itself prove active syphilis, and false-positive or false-negative results can occur; interpretation should account for symptoms, history, and other laboratory findings.
- The test is an in-vitro diagnostic kit, not an implantable or patient-contact device, so MRI compatibility, vessel size, and implant duration do not apply.
- Reagents should be stored, handled, and used according to the current manufacturer labeling, including requirements for expiration, contamination control, and laboratory quality procedures.
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 Stanbio Syphilis RPR Test No 1170 used for?
It is used for the detection of syphilis by identifying non-treponemal antibodies in the blood.
What specialties typically use this device?
Infectious disease specialists, general practitioners, and obstetricians, particularly in STI clinics and prenatal care settings.
What are the FDA-cleared indications?
The test is indicated for the qualitative detection of reagin antibodies in human serum or plasma to screen for syphilis infection.
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.