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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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