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hemohlobin a2 control-lyophilized
Isolab
Summary: The Hemoglobin A2 Control-Lyophilized by Isolab is a diagnostic control used in laboratory settings to ensure the accuracy of hemoglobin A2 measurements. It is primarily used by clinical laboratory professionals.
FDA Clearance Information
Pathway
510K
Number
K801410 ↗
Decision Date
July 21, 1980
Product Code
JPD
Device Class
Class 2
Evidence
419 studies
The Hemoglobin A2 Control-Lyophilized by Isolab was cleared through the FDA 510k pathway on July 21, 1980. It is classified as a Class 2 device under product code JPD.
What It Is
The Hemoglobin A2 Control-Lyophilized is a laboratory control product used to verify the accuracy and precision of hemoglobin A2 testing in clinical laboratories. This lyophilized control is reconstituted and run alongside patient samples to ensure the reliability of hemoglobin electrophoresis or chromatography assays. It is essential for maintaining quality control in diagnostic testing for hemoglobinopathies.
Clinical Applications
This device is commonly used in clinical laboratories that perform hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) to diagnose hemoglobin disorders such as beta-thalassemia. It is used by laboratory technicians and pathologists to ensure test accuracy, particularly in settings where precise quantification of hemoglobin A2 is critical for patient diagnosis and management.
Indications for Use
The FDA indications for this device involve its use as a quality control measure in the laboratory testing of hemoglobin A2 levels. It is intended for use in patients undergoing evaluation for hemoglobinopathies, ensuring accurate diagnostic results.
Practical Considerations
The Hemoglobin A2 Control-Lyophilized is typically provided in a format that requires reconstitution before use. It is compatible with various hemoglobin testing platforms, and users should follow specific reconstitution and storage instructions to maintain its stability and effectiveness.
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
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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 Hemoglobin A2 Control-Lyophilized used for?
It is used as a quality control measure in laboratory testing to ensure accurate hemoglobin A2 measurements.
What specialties typically use this device?
Clinical laboratory professionals, particularly those specializing in hematology and pathology, use this device.
What are the FDA-cleared indications?
It is indicated for use as a quality control in laboratory testing of hemoglobin A2 levels, particularly in diagnosing hemoglobinopathies.
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.