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Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.

Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "CardioImmune Cardiac Marker Control Levels 1, 2, and 3". This document approves the device for market but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it does not detail the specific performance metrics or studies directly validating its performance against acceptance criteria in the manner requested.

Therefore, I cannot provide the information you asked for based on the input text.

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Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.

Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "CardioImmune Cardiac Marker Control Level 1, 2, and 3". It does not contain information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

Instead, the document primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States the intended use of the device.
• Outlines general regulatory information for the manufacturer.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given text.

Ask a specific question about this device

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Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations. The controls are prepared from a human serum matrix with the addition of various constituents. Preservatives and stabilizers are added to maintain product integrity. The liquid matrix eliminates causes of vial to vial variability and, when handled as directed, provides consistency in day-to-day testing.

This document is a 510(k) submission for a medical device (CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3). It does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described for an AI/ML powered medical device.

The document focuses on:

• Establishing substantial equivalence to an existing device (LiquichekTM Cardiac Markers Control, K961828).
• Describing the product's intended use (monitoring test procedures for cardiac marker determinations).
• Providing details on its composition (human serum matrix, preservatives, stabilizers).
• Mentioning its stability (36 months at -20°C, 60 days unopened at 2-8°C, 30 days opened at 2-8°C).
• Product code.

Therefore, I cannot provide the requested information. The document does not contain data related to:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for a test set, or its data provenance.
3. Number/qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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