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lyophilized g-hb quik column control
Helena Laboratories
Summary: The Lyophilized G-Hb Quik Column Control by Helena Laboratories is a device used in laboratory settings for quality control of hemoglobin assays. It is primarily used by laboratory technicians and clinical pathologists.
FDA Clearance Information
Pathway
510K
Number
K791135 ↗
Decision Date
June 28, 1979
Product Code
LCP
Device Class
Class 2
Evidence
419 studies
The Lyophilized G-Hb Quik Column Control was cleared through the FDA 510k pathway on June 28, 1979, by Helena Laboratories. It is classified as a Class 2 medical device under product code LCP.
What It Is
The Lyophilized G-Hb Quik Column Control is a laboratory device used to ensure the accuracy and reliability of hemoglobin assay results. It is a lyophilized product, meaning it is freeze-dried for stability and long shelf life. This control is crucial for laboratories to maintain quality assurance in hemoglobin testing, which is vital for diagnosing and monitoring conditions like anemia and diabetes.
Clinical Applications
This device is commonly used in clinical laboratories, particularly in settings where hemoglobin testing is routine, such as hospitals and diagnostic centers. It is essential for ensuring the precision of hemoglobin A1c tests, which are critical for managing diabetic patients. Laboratory technicians and clinical pathologists use this control to validate the performance of hemoglobin assays, ensuring accurate patient results.
Indications for Use
The FDA indications suggest that this device is intended for use in quality control of hemoglobin assays. It is particularly relevant for patients undergoing testing for conditions like anemia and diabetes, where accurate hemoglobin measurement is crucial.
Practical Considerations
The device is typically available in a lyophilized form, requiring reconstitution before use. It is compatible with various hemoglobin assay systems, but users should verify compatibility with their specific equipment. Proper technique in reconstitution and handling is important to maintain the integrity of the control.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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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
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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 Lyophilized G-Hb Quik Column Control used for?
It is used for quality control in hemoglobin assays to ensure accurate and reliable test results.
What specialties typically use this device?
Clinical pathologists and laboratory technicians in hospital and diagnostic laboratory settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in quality control of hemoglobin assays, ensuring accurate measurement in conditions like anemia and diabetes.
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.