đź“Š Evidence-Based Reference
sandare lyophilized hemoglobin controls
Sandare Chemical
Summary: Sandare Lyophilized Hemoglobin Controls are used for hemoglobin analysis in clinical laboratories. They provide a standardized control material for accurate testing. Key evidence highlights their role in quality improvement for hemoglobin testing.
FDA Clearance Information
Pathway
510K
Number
K800780 ↗
Decision Date
April 24, 1980
Product Code
JPK
Device Class
Class 2
Evidence
419 studies
The Sandare Lyophilized Hemoglobin Controls were cleared by the FDA via the 510(k) pathway on April 24, 1980. Manufactured by Sandare Chemical, they are classified as Class 2 devices.
What It Is
Sandare Lyophilized Hemoglobin Controls are standardized control materials used in the analysis of hemoglobin levels in clinical settings. They are designed to ensure accuracy and consistency in hemoglobin testing, particularly for conditions like thalassemia.
Clinical Applications
These controls are commonly used in laboratories for the quality assessment of hemoglobin tests, including HbA2 and HbF levels. They are particularly useful in settings where precise hemoglobin quantification is critical, such as in the diagnosis of hemoglobinopathies.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2018 and 2025. These studies focus on the performance and development of hemoglobin control materials.
Reported Outcomes
Published studies report that the use of lyophilized hemoglobin controls improves the accuracy and reliability of hemoglobin testing in clinical laboratories. They are particularly effective in external quality assessment programs, enhancing the precision of HbA2 and HbF measurements.
Safety Profile
Reported complications include the potential for variability in test results if the controls are not properly stored or handled. However, no significant adverse events have been documented in the available studies.
Evidence Limitations
Current evidence is limited by the lack of large-scale, multicenter trials. Further research is needed to explore the long-term stability of these controls and their performance across diverse laboratory settings.
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 Sandare Lyophilized Hemoglobin Controls?
These controls are indicated for use in the quality assessment of hemoglobin testing, particularly for conditions like thalassemia.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy and reliability in hemoglobin testing, with enhanced precision in HbA2 and HbF measurements.
What complications have been reported?
Reported complications include potential variability in test results due to improper storage or handling, but no significant adverse events have been documented.
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.