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PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

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The provided text is a 510(k) premarket notification letter from the FDA to Mitsubishi Kagaku Iatron Inc. regarding their PATHFAST CK-MB-II and PATHFAST Myo-II diagnostic tests. It primarily addresses the regulatory approval of these devices and their intended use. It does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation section.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval and indications for use, not on the detailed technical performance data or study methodology.

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PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings.

PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATHFAST® System.

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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested.

The letter confirms that the PATHFAST hsCRP test is substantially equivalent to legally marketed predicate devices. To provide the requested information, I would need to analyze the actual 510(k) submission document (K083412), which is not provided here.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth was established for the training set.

The provided document is merely the FDA's clearance letter acknowledging the 510(k) submission and its determination of substantial equivalence. The actual performance data and study details would be in the submission itself.

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