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This document serves as a summary for the 510(k) premarket notification for the COBAS INTEGRA Glucose HK Gen. 3 Assay, providing details necessary for the determination of its substantial equivalence
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How to fill out cobas integra glucose hk
How to fill out COBAS INTEGRA Glucose HK Gen. 3 Assay
01
Ensure that all necessary materials and reagents are available and within the expiration date.
02
Calibrate the COBAS INTEGRA analyzer according to the manufacturer's instructions.
03
Prepare the samples by ensuring they are mixed well and stored at the correct temperature prior to testing.
04
Place the sample in the designated sample container.
05
Program the analyzer to select the Glucose HK Gen. 3 assay protocol.
06
Load the sample container into the analyzer's sample tray.
07
Initiate the test by following prompts on the analyzer interface.
08
After the test is completed, retrieve and review the results for quality control.
09
Document all results and maintain proper records.
Who needs COBAS INTEGRA Glucose HK Gen. 3 Assay?
01
Healthcare laboratories that require glucose testing for diabetes management.
02
Clinical settings that need to monitor glucose levels in patients.
03
Research facilities conducting studies on glucose metabolism.
04
Pharmaceutical companies involved in diabetes-related drug development.
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People Also Ask about
Is Cobas a PCR?
PCR technology at the point of care The cobas® liat system uses gold-standard PCR technology to provide accurate and actionable results in 20 minutes or less, enabling health care providers to test to treat during a single patient visit.
What is cobas integra?
Cobas Integra: clinical laboratory instrument with continuous and random-access capabilities.
What is the glucose HK test?
The hexokinase method is a diagnostic test that accurately measures glucose concentration in biological fluids. This method is commonly used to estimate plasma glucose levels and is highly accurate and robust.
What does a Cobas machine do?
How the Roche Cobas analyzer works. The Roche e 411 Cobas analyzer employs ECL technology to detect extremely low levels of antigen, yielding high sensitivity and the ability to detect subtle changes in antigen levels. The Roche c 311 Cobas analyzer performs photometric assays and ion-selective electrode measurements.
What is glucose HK Gen 3?
HK3 Gene - Hexokinase 3 Hexokinases phosphorylate glucose to produce glucose-6-phosphate, the first step in most glucose metabolism pathways. This gene encodes hexokinase 3. Similar to hexokinases 1 and 2, this allosteric enzyme is inhibited by its product glucose-6-phosphate.
What is Cobas PCR test?
The cobas® PCR Sample Kit is used to collect and transport specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for specimens. Use this collection kit only with the cobas® 4800 CT/NG Test.
What is Cobas Integra 400 Plus used for?
This analyzer is the perfect solution for our laboratories running up to 400 samples per day. Its broad test menu comprises over 120 assays and applications that consolidate clinical chemistry with specific proteins, therapeutic drug monitoring and drug abuse testing.
What is GLUC3?
GLUC3: ACN 8717. SGLU3: ACN 8668 (STAT, reaction time: 7) Intended use. In vitro test for the quantitative determination of glucose in human serum, plasma, and CSF on Roche/Hitachi cobas c systems. Summary1,2,3.
What is 3 OMG glucose?
The 3-OMG is commonly used as a non-metabolized analogue of glucose by regulating glucose transporter, especially GLUT-4 that regulates the absorption of glucose by insulin into muscle and cells. This study supports the black gram seed with coat as an alternative medicine to regulate blood glucose.
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What is COBAS INTEGRA Glucose HK Gen. 3 Assay?
The COBAS INTEGRA Glucose HK Gen. 3 Assay is a diagnostic test used to measure the concentration of glucose in blood samples, utilizing hexokinase enzymatic methodology for accurate results.
Who is required to file COBAS INTEGRA Glucose HK Gen. 3 Assay?
Healthcare facilities and laboratories that conduct glucose testing as part of patient diagnostics are required to implement and file results using the COBAS INTEGRA Glucose HK Gen. 3 Assay.
How to fill out COBAS INTEGRA Glucose HK Gen. 3 Assay?
To fill out the assay, follow the manufacturer's instructions for sample collection and handling, input patient data and the collected blood sample into the COBAS INTEGRA system, and ensure quality control checks are performed before obtaining results.
What is the purpose of COBAS INTEGRA Glucose HK Gen. 3 Assay?
The purpose of the COBAS INTEGRA Glucose HK Gen. 3 Assay is to provide healthcare professionals with accurate measurements of blood glucose levels for diagnosing and managing conditions such as diabetes.
What information must be reported on COBAS INTEGRA Glucose HK Gen. 3 Assay?
The information that must be reported includes the patient’s glucose concentration level, units of measurement, patient identification details, and the date and time of the test.
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