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Syphilis Igg Human Serum Controls
Pyramid Biological
Summary: Syphilis IgG human serum controls by Pyramid Biological are used for serological testing of syphilis. FDA cleared via 510k pathway. Key evidence highlights non-invasive diagnostic methods for neurosyphilis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K960493 ↗
Decision Date ?
June 17, 1996
Product Code ?
LIP
Device Class ?
Class 2
Evidence ?
419 studies
The syphilis IgG human serum controls were cleared by the FDA through the 510k pathway on June 17, 1996. Manufactured by Pyramid Biological, the device is classified as Class 2 under product code LIP.
What It Is
The device consists of human serum controls designed to aid in the serological testing for syphilis by detecting IgG antibodies. It is intended for use in clinical laboratories to support the diagnosis of syphilis.
FDA-Cleared Indications
- For use as controls in serological testing for syphilis.
- For monitoring the performance of assays that detect IgG antibodies associated with Treponema pallidum infection.
Clinical Applications
- Quality control during laboratory serological testing for syphilis.
- Verification that a syphilis IgG antibody assay is performing as expected.
- Supporting laboratory testing used in the evaluation of suspected syphilis infection.
- Use by trained clinical laboratory personnel according to the assay manufacturer’s instructions.
Evidence Summary
The literature includes 10 studies, ranging from 2019 to 2024, covering various diagnostic approaches for syphilis, including non-invasive methods for neurosyphilis. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report advancements in non-invasive diagnostic methods for neurosyphilis, such as the use of immunoassays to detect specific antibodies. Other studies highlight the differentiation of syphilis stages using IgG and IgM levels.
Safety Profile
Reported complications include potential false-positive results in serological testing, which can be mitigated by specific dissociation techniques. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to validate non-invasive diagnostic methods and to explore long-term outcomes of serological testing.
Practical Considerations
- This is an in vitro laboratory control, not a therapeutic product or a device implanted in a patient.
- Use the control only with compatible assays and according to the product labeling and testing system instructions.
- Store, handle, mix, and dispose of the serum according to the manufacturer’s instructions and applicable biosafety procedures.
- Because the material is human-derived, laboratories should use appropriate precautions for potentially infectious biological materials.
- The FDA record does not identify a body size, vessel size, MRI restriction, or procedural contraindication; expiration and stability depend on the specific product labeling.
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 are the clinical indications for syphilis IgG human serum controls?
The device is indicated for the serological diagnosis of syphilis, particularly in confirming Treponema pallidum infection.
What outcomes have been reported in clinical studies?
Studies report successful differentiation of syphilis stages and the development of non-invasive diagnostic methods for neurosyphilis.
What complications have been reported?
Safety data indicate potential false-positive results, which can be addressed with specific laboratory techniques.
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.