đź“Š Evidence-Based Reference
lyophilized hdl cholesterol controls
Helena Laboratories
Summary: Lyophilized HDL cholesterol controls by Helena Laboratories are used for clinical lipid testing. Cleared by FDA in 1979, they are primarily used to ensure accuracy in cholesterol measurement. Key evidence includes studies on lipid modulation and cholesterol control.
FDA Clearance Information
Pathway
510K
Number
K792025 ↗
Decision Date
October 30, 1979
Product Code
JJY
Device Class
Class 1
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on October 30, 1979. Manufactured by Helena Laboratories, it is classified as a Class 1 device under product code JJY.
What It Is
Lyophilized HDL cholesterol controls are used in clinical laboratories to calibrate and validate lipid testing equipment. They ensure accurate measurement of HDL cholesterol levels, which is crucial for assessing cardiovascular risk.
Clinical Applications
These controls are commonly used in clinical settings to verify the accuracy of HDL cholesterol assays. They are essential in laboratories performing lipid profiles for cardiovascular risk assessment.
Evidence Summary
The available literature includes 11 studies, primarily randomized controlled trials and prospective studies, conducted between 2014 and 2021. These studies explore the effects of various interventions on HDL cholesterol levels.
Reported Outcomes
Published studies report that lyophilized extracts and dietary interventions can influence HDL cholesterol levels. For instance, high-fat diets supplemented with specific plant extracts have shown to increase HDL cholesterol levels and inhibit adipocyte hypertrophy.
Safety Profile
Reported complications include potential variability in HDL cholesterol measurement accuracy due to differences in assay calibration. No direct adverse events related to the use of lyophilized HDL cholesterol controls were noted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the specific focus on dietary and plant extract interventions. Further research is needed to explore the broader clinical implications and long-term safety of these controls.
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 lyophilized HDL cholesterol controls?
They are indicated for use in clinical laboratories to ensure the accuracy of HDL cholesterol assays, which are critical for cardiovascular risk assessment.
What outcomes have been reported in clinical studies?
Studies have reported that certain dietary interventions can increase HDL cholesterol levels, with lyophilized extracts showing potential benefits in lipid modulation.
What complications have been reported?
Safety data from evidence indicates potential variability in assay calibration, but no direct adverse events related to the controls themselves.
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.