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fast hemoglobin control-lyophilized
Isolab
Summary: Fast hemoglobin control-lyophilized by Isolab is a device used in clinical settings for managing hemoglobin levels. It is FDA-cleared under 510k pathway. Current evidence includes studies primarily focused on diabetes-related interventions.
FDA Clearance Information
Pathway
510K
Number
K800794 ↗
Decision Date
April 29, 1980
Product Code
LCP
Device Class
Class 2
Evidence
419 studies
The fast hemoglobin control-lyophilized device by Isolab was cleared by the FDA on April 29, 1980, under the 510k pathway. It is classified as a Class 2 device with product code LCP.
What It Is
The fast hemoglobin control-lyophilized is a device designed to assist in the management of hemoglobin levels in patients. It is used in clinical settings to ensure accurate hemoglobin measurements, particularly in scenarios requiring precise control.
Clinical Applications
This device is commonly used in clinical laboratories and hospitals where accurate hemoglobin level management is critical. It is particularly relevant in settings dealing with conditions such as anemia or polycythemia.
Evidence Summary
The available literature includes five studies, primarily focusing on diabetes-related interventions. These studies are registered on clinical trial platforms, with varying study types and no specified total participant numbers or date ranges.
Reported Outcomes
Published studies report outcomes related to diabetes management, including pharmacokinetics and efficacy of related treatments. However, specific outcomes related to the fast hemoglobin control-lyophilized device itself are not detailed in the provided evidence.
Safety Profile
Reported complications include general safety concerns associated with diabetes treatments, but specific adverse events related to the fast hemoglobin control-lyophilized device are not detailed in the provided studies.
Evidence Limitations
The evidence provided lacks specific data on the fast hemoglobin control-lyophilized device, focusing instead on broader diabetes-related interventions. Further research is needed to directly assess the device's efficacy and safety.
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 fast hemoglobin control-lyophilized?
The device is indicated for use in managing hemoglobin levels, particularly in clinical settings requiring precise control.
What outcomes have been reported in clinical studies?
The studies primarily report on diabetes management outcomes, with no specific outcomes detailed for the device itself.
What complications have been reported?
Safety data from the studies focus on diabetes treatments, with no specific complications reported for the device.
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.