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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.

Not Found

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.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size for the test set used in performance evaluations (e.g., precision, method comparison, interfering substances). It refers generically to "samples" for precision and provides a "Range" for method comparison without indicating the number of individual patient samples.
The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement, and its performance is assessed against established analytical methods and reference standards, not against expert human interpretation of images or other diagnostic findings.

4. Adjudication Method for Test Set

Not applicable. Clinical test performance is determined by a quantitative measurement against a comparative method.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not a medical imaging or diagnostic aid that involves human reader interpretation.

6. Standalone (Algorithm Only) Performance

Yes, the performance characteristics (Precision, Assay Range, Analytical Sensitivity, Method Comparison, Interfering Substances, Stability) represent the standalone performance of the Olympus D-Dimer Test System, as measured on Olympus analyzers, without human intervention in the result generation beyond operating the instrument.

7. Type of Ground Truth Used

The ground truth for evaluating the Olympus D-Dimer Test System implicitly relies on:

• A commercially available assay (predicate device, Roche Tina-Quant® D-Dimer) for method comparison. This assay itself would have been validated against a traceable standard.
• In-house Master Calibrator: The Olympus D-Dimer Test System is traceable to an in-house Master Calibrator.
• Defined concentrations/levels: For precision studies, specific "samples" (likely control materials or spiked plasma) are used with known D-Dimer concentrations. For interfering substances, known concentrations of bilirubin, hemoglobin, rheumatoid factor, heparin, and lipids are added to samples.

8. Sample Size for the Training Set

Not applicable. This is an analytical immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI/ML algorithms. The development and optimization of the reagent and assay would involve various experimental and testing phases, but these are not referred to as training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is performed using a 6-point calibration curve, which is described as being traceable to an in-house Master Calibrator and aligned with another commercially available test system. This establishes the analytical accuracy of the measurements.

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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.

Summary of Acceptance Criteria and Performance:

• Precision: For AU400/400e, the new device shows higher CV% values (less precise) than the predicate for all samples. For AU600/640/640e and AU2700/5400, the new device generally shows lower (better) CV% values than the predicate. Without explicit thresholds, it's hard to say if the higher CVs on AU400/400e meet acceptance, but the improvements on other instruments are positive.
• Assay Range: The new device matches the predicate's assay range.
• Sensitivity: The new device shows a larger change in absorbance per U/L, suggesting potentially better sensitivity than the predicate.
• Method Comparison: The R2 value of 1.000 for the new device is excellent, indicating strong linearity and agreement with the predicate. The slope and intercept are also very close, demonstrating substantial equivalence in performance. The range is comparable although slightly different.
• Interfering Substances: The performance varies. For bilirubin, the new device sometimes shows a higher percentage interference but often allows for higher concentrations of bilirubin (e.g., 40 mg/dL vs 24 mg/dL on AU2700/5400). For lipemia, the new device generally shows a higher percentage of interference but also allows for much higher concentrations of intralipid (e.g., 900 mg/dL vs 200 mg/dL on AU600/640/640e). These differences would need to be evaluated against specific clinical requirements for acceptable interference.

2. Sample Size Used for the Test Set and Data Provenance

The document provides specific data points for precision (using 3 samples per instrument type, but the number of replicates for each sample is not specified). For method comparison, a range of 12-1860 U/L is given, implying a comparison against samples across this range, but the exact number of individual samples is not stated.

Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that it's a submission by "Olympus Life and Material Science Europa GmbH" from Ireland, it's likely the testing was conducted in Europe. The context suggests a prospective laboratory study to generate performance data for the new reagent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device. This document describes an in vitro diagnostic (IVD) reagent for quantitative determination of a biomarker (CK-MB). The "ground truth" or reference method for such devices is typically an established laboratory method (e.g., the predicate device or a recognized standard method like the IFCC or Szasz method mentioned). The accuracy is determined by analytical performance against these methods or known concentrations, not by expert consensus on visual assessment or clinical interpretation.

4. Adjudication Method for the Test Set

This section is not applicable to this type of device. Adjudication refers to processes like multiple reviewers resolving discrepancies, which is common in image interpretation or clinical decision-making. For an IVD reagent, performance is objectively measured against analytical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable to this type of device. MRMC studies are typically for medical imaging or interpretation devices where human readers are involved. This device is an automated laboratory reagent.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is essentially what the performance data presented represents. The "device" (reagent) is used on automated Olympus analyzers to produce quantitative results. The performance characteristics (precision, sensitivity, method comparison, interference) are measurements of the reagent's analytical performance on these instruments, without human interpretation influencing the numerical result.

7. The Type of Ground Truth Used

The ground truth for evaluating the Olympus CK-MB Reagent (OSR6x155) is based on:

• Comparison to a legally marketed predicate device: Olympus OSR6X53 CK-MB method (K971817). The performance of the new reagent is directly compared side-by-side with this predicate.
• Theoretical extinction coefficients: The calibration of the new device is based on the theoretical extinction coefficient for NADPH, while the predicate used NADP. This indicates a reliance on established chemical principles for quantification.
• Modification of established methods: The new procedure is described as a "modification of the IFCC method," which is a widely recognized standard for CK measurements. The predicate was a modification of the Szasz method, another established method. This implies that the 'ground truth' is tied to these established analytical methodologies.

8. The Sample Size for the Training Set

The document does not provide information about a "training set." For an IVD reagent, development typically involves optimizing the chemical formulation and reaction conditions. While there's an R&D phase where different formulations are tested, there isn't a "training set" in the sense of machine learning algorithms. The performance characteristics presented are from verification and validation testing, not a dataset used to "train" the reagent.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" for this type of device in the context of machine learning, this question is not applicable. The "ground truth" for the development of such reagents would involve rigorous chemical and analytical testing against known standards and established reference methods to ensure accurate and reliable measurements.

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