Glucocard R W Onyx Blood Glucose Monitoring System
Arkray Factory
FDA Clearance Information
The Glucocard R W Onyx Blood Glucose Monitoring System was cleared through the FDA 510(k) pathway on April 10, 2019. Manufactured by Arkray Factory, it is classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- For quantitative measurement of glucose in fresh capillary whole blood samples.
- For use by people with diabetes and healthcare professionals to monitor blood glucose levels.
- For use with blood samples obtained from a fingerstick or other labeled capillary sampling site.
- For in vitro diagnostic use; it is not intended to diagnose diabetes by itself.
Clinical Applications
- Self-monitoring of blood glucose by people with diabetes.
- Blood glucose checks in outpatient or primary care settings.
- Blood glucose measurement in diabetes management programs.
- Use by healthcare professionals when evaluating a patient's current blood glucose level.
- Monitoring glucose trends to support treatment decisions made with a healthcare professional.
Practical Considerations
- The meter requires compatible Glucocard test strips and an appropriate small blood sample; users should follow the current instructions for use.
- The usual sampling method is a fingerstick using a sterile lancet. Hand washing, adequate drying, correct strip storage, and proper blood application help reduce inaccurate readings.
- This is a glucose-monitoring device, not a continuous glucose monitor and not a replacement for laboratory testing when confirmatory testing is clinically necessary.
- It is not an implanted device and has no MRI-related implant restrictions. Keep the meter, strips, and lancets dry and within their labeled storage conditions.
- Do not use a glucose result alone to make urgent treatment decisions when the reading does not match symptoms; repeat the test or seek medical advice according to the patient's care plan.
Linked Studies (20)
Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.
American heart journal
RCT|prospective|retrospective|case Series|other View Source →OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.
Gels (Basel, Switzerland)
View Source →The resolute Onyx in TIA management (ROTIA).
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →Spinal tumor embolization with Onyx: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.
Pediatric neurosurgery
RCT|prospective|retrospective|case Series|other View Source →The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.
World neurosurgery
RCT|prospective|retrospective|case Series|other View Source →Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.
Clinical neurology and neurosurgery
View Source →Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.
Operative neurosurgery (Hagerstown, Md.)
RCT|prospective|retrospective|case Series|other View Source →Onyx™ Cast Fragmentation After Embolization of Endoleaks.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.
Turkish journal of orthodontics
RCT|prospective|retrospective|case Series|other View Source →Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.
Medical dosimetry : official journal of the American Association of Medical Dosimetrists
Retrospective View Source →Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.
Journal of neurointerventional surgery
Case Series View Source →Percutaneous transorbital embolization of a carotid cavernous fistula.
Proceedings (Baylor University. Medical Center)
RCT|prospective|retrospective|case Series|other View Source →Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).
Cardiology journal
RCT|prospective|retrospective|case Series|other View Source →Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Glucocard R W Onyx Blood Glucose Monitoring System used for?
It is used to measure blood glucose levels in patients with diabetes for effective management of their condition.
What specialties typically use this device?
Endocrinologists, diabetologists, primary care physicians, and patients themselves commonly use this device.
What are the FDA-cleared indications?
The device is indicated for monitoring blood glucose levels in patients with diabetes to assist in managing their condition.