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The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors.

For in vitro diagnostic use only.

The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System.

The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

The Olympus Alpha-fetoprotein (AFP) Test System is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System.

The provided text is a 510(k) premarket notification acceptance letter for the Olympus AFP Test System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device but does not detail the performance metrics or study design.

Therefore, I cannot provide the requested information based on the provided input.

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System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.

Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

For in vitro diagnostic use.

The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called "The Olympus Direct Bilirubin Reagent (OSR6X181)". This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to fill out the requested table and answer the specific questions about device performance and validation studies.

The letter focuses on regulatory approval based on substantial equivalence, rather than providing the performance data from the studies that supported that equivalence. To answer your questions, I would need access to the actual 510(k) submission, which typically includes the detailed study reports.

Therefore, I cannot provide the requested information based on the input text.

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The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.

The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System.

The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.

The Olympus Total BhCG Test System (OS210303). The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Olympus Total BhCG Test System, confirming its substantial equivalence to a legally marketed predicate device. It defines the device, its intended use, and regulatory information but does not include details on specific performance metrics, acceptance criteria, or a study report.

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The Olympus fT4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. For in vitro diagnostic use only.

The Olympus T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. For in vitro diagnostic use only.

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This document is a 510(k) premarket notification decision letter from the FDA regarding the Olympus FT4 Free thyroxine and Olympus T4 Total thyroxine test systems. It does not contain the specific details about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting.

The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements but does not delve into the technical validation studies.

To answer your questions, you would need to refer to the actual 510(k) premarket notification submission itself, which typically includes detailed study reports, performance data, and other validation information. This letter only provides the FDA's decision based on that submission.

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System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.

Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles

The Olympus D-Dimer Test System, consisting of the Olympus D-Dimer Reagent, Calibrator, and Control, is intended for the quantitative determination of D-Dimer in human plasma on Olympus analyzers. It is designed to aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation.

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary compares the Olympus D-Dimer Test System with the predicate device, Roche Tina-Quant® D-Dimer Test System. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate, with specific performance characteristics indicating acceptable levels.

• Bilirubin up to 20 mg/dL
• Hemolysis up to 500 mg/dL Hemoglobin
• Rheumatoid Factor

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System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers.
Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

In this Olympus procedure: The R1 reagent antibody binds to the M subunit of CK in the serum sample. The B subunit of the enzyme acts on the substrate present in the R2 reagent. CK reversibly catalyzes the transfer of a phosphate group from creatine phosphate to ADP to give creatine and ATP. The ATP is used to produce glucose-6-phosphate and ADP, catalyzed by hexokinase (HK) which requires magnesium ions for maximum activity. The glucose-6-phosphate is oxidized by the action of the enzyme G6P-DH with simultaneous reduction of the coenzyme NADP to give NADPH and 6-phosphogluconate. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample.

Here's an analysis of the provided text regarding the Olympus CK-MB Reagent (OSR6x155), focusing on the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document compares the new Olympus CK-MB (OSR6x155) reagent with a predicate device (Olympus CK-MB OSR6x53). While explicit "acceptance criteria" for performance are not directly stated in the format of a threshold to be met, the comparison with the predicate device implies that performance similar to or better than the predicate is the acceptance standard.

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