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Intended for use with Olympus reagents for the establishment of reference points used in the determination of values for specific constituents found in human serum. The five constituents are ceruloplasmin, alpha-l-acidglycoprotein, alpha-2-macroglobulin, haptoglobin, and beta-2-microglobulin.

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This document is a marketing clearance letter from the FDA for the Olympus® Serum Protein Multicalibrator 2. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would.

The letter states that the device is "substantially equivalent" to predicate devices, which is the basis for its 510(k) clearance. This type of clearance generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to prove performance against pre-defined acceptance criteria for a novel technology.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as:

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

Are typically found in performance studies for diagnostic devices (especially those involving AI/ML) that are subject to more rigorous performance evaluations, often for PMA applications or novel 510(k) devices that don't have suitable predicates for substantial equivalence.

In summary, this document is a regulatory clearance based on substantial equivalence, not a performance study report with acceptance criteria.

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The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Serum Protein Multicalibrator. This document is a regulatory approval letter and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided.

Therefore, I cannot extract the requested information. The document only states that the FDA has determined the device is "substantially equivalent" to previously marketed devices.

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The Olympus Serum Protein Multicalibrator is designed for use in Olympus automated clinical chemistry analyzers for IgG, IgA, IgM, C3, C4, Transferrin, Ferritin, CRP, and ASO determinations.

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The provided document is an FDA 510(k) clearance letter for the "Olympus Serum Protein Multi Calibrator." This letter generally does not contain detailed information about acceptance criteria or specific study results for device performance as you've requested.

The 510(k) process primarily demonstrates substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While the submission for a 510(k) would include performance data to support substantial equivalence, the clearance letter itself is a summary of the FDA's decision and does not elaborate on the specific studies.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.

To obtain this information, you would typically need to consult the original 510(k) submission documentation, which is often much more extensive than the clearance letter. This documentation would contain the test plans, results, and analyses that supported the claims of the device manufacturer and led to the FDA's clearance.

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