đź“‹ FDA Reference
Vis-Disk Hcg Eia Lyophilized Jpl-044m
Leeco Diagnostics
Summary: The vis-disk hcg eia lyophilized jpl-044m is a diagnostic device used for detecting human chorionic gonadotropin (hCG) levels. It is primarily used by laboratory technicians and clinicians in diagnostic settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K891095 ↗
Decision Date ?
June 16, 1989
Product Code ?
DHA
Device Class ?
Class 2
Evidence ?
419 studies
The vis-disk hcg eia lyophilized jpl-044m was cleared through the FDA 510(k) pathway on June 16, 1989. Manufactured by Leeco Diagnostics, it is a Class 2 device under product code DHA.
What It Is
The vis-disk hcg eia lyophilized jpl-044m is an enzyme immunoassay (EIA) designed to detect the presence of human chorionic gonadotropin (hCG) in biological samples. This lyophilized assay is commonly used in clinical laboratories to confirm pregnancy or diagnose conditions related to abnormal hCG levels. The device uses a colorimetric detection method to provide quantitative results.
FDA-Cleared Indications
- In vitro qualitative or quantitative detection of human chorionic gonadotropin (hCG) in human specimens, as specified by the product labeling.
- Use as an aid in the laboratory evaluation of pregnancy when hCG testing is clinically indicated.
Clinical Applications
- Laboratory testing of hCG in urine or serum specimens when evaluating a possible pregnancy.
- Measurement of hCG when monitoring a previously established clinical condition for which serial hCG results are ordered.
- Use by trained laboratory personnel with compatible enzyme immunoassay equipment and procedures.
Practical Considerations
- This is a laboratory assay, not an implantable, injectable, or imaging device; MRI safety labeling does not apply in the usual device sense.
- The assay is supplied in lyophilized form and requires reconstitution, specimen preparation, controls, calibration, and storage according to the manufacturer’s instructions.
- Specimen type, reportable range, detection threshold, and whether results are qualitative or quantitative must be confirmed in the original package insert.
- Results can be affected by specimen handling, assay interference, or cross-reactivity with related glycoprotein hormones; unexpected results should be interpreted with clinical findings and, when appropriate, repeat testing.
- The FDA record identifies this as a Class II device cleared through the 510(k) pathway under product code DHA; the 1989 clearance does not by itself establish current availability or current 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 is vis-disk hcg eia lyophilized jpl-044m used for?
It is used for detecting human chorionic gonadotropin (hCG) levels to confirm pregnancy or monitor certain cancers.
What specialties typically use this device?
Obstetrics, gynecology, and oncology specialties typically use this device in clinical laboratory settings.
What are the FDA-cleared indications?
The device is indicated for detecting hCG levels in patients for pregnancy confirmation or monitoring hCG-secreting tumors.
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.