FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA). It is substantially equivalent to the Ciba-Corning Magic Lite CK-MB assay.

AI/ML Overview

Below is a summary of the acceptance criteria and study information for the VIDAS CKMB assay, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit from Study Findings)	Reported Device Performance
Correlations	Strong correlation with predicate device (Ciba-Corning Magic Lite CK-MB assay), and calibration stability of the master curve.	Correlation coefficient of 0.97 (y = 0.83x - 0.656). Master curve valid for kit shelf life with single calibrator in duplicate.
Sensitivity	Ability to measure CKMB levels between 0.8 ng/ml and 300 ng/ml, with a lowest measurable level distinguishable from zero.	Measures CKMB between 0.8 ng/ml and 300 ng/ml. Lowest measurable level: 0.8 ng/ml (with 95% probability).
Cross-reactivity	Specificity for CKMB isoform, with no cross-reactivity with BB and MM isoforms.	Antibodies specific for CKMB isoform. No cross-reactivity with BB or MM isoforms.
Interfering Substances	No interference from various blood collection tubes or from hemoglobin, lipids, or bilirubin within tested ranges.	No interference from dry glass tubes with glycerolated cap, separating gel tubes, siliconized/non-siliconized tubes, EDTA tubes, heparin tubes. No interference from tested ranges of hemoglobin, lipids, or bilirubin.
Precision/Reproducibility	Acceptable intra-assay, inter-assay, and inter-instrument coefficients of variation (CVs).	Intra-assay CVs: 3.2% - 6.2%.
		Inter-assay CVs (8-week): ≤ 7.2%.
		Inter-assay, inter-instrument CVs (5 samples, 9 assays, different instruments): ≤ 16.7%.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not explicitly state the total number of samples used for all the performance studies.
- For the correlation study, the sample size is not specified beyond "a comparison of the VIDAS CKMB assay with the Ciba-Corning Magic Lite CK-MB assay yields a line...".
- For the inter-assay, inter-instrument reproducibility, 5 different serum samples were used.
- The sample sizes for sensitivity, cross-reactivity, interfering substances, and intra-assay/inter-assay precision are not detailed.
Data Provenance: Not specified. There is no mention of the country of origin of the data, nor whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: This assay measures the concentration of creatine kinase MB isoenzyme. The "ground truth" for quantitative assays like this is typically established by reference methods or established analytical techniques, often using certified calibrators or highly characterized samples, rather than human expert consensus, pathology, or outcomes data. The document refers to a "calibrator in the kit" that ensures the master curve's validity.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or making subjective diagnoses. For a quantitative immunoassay like the VIDAS CKMB, the "ground truth" is determined analytically, and human adjudication is not relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is a diagnostic assay for measuring a biomarker, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Yes (Implicit): The studies described (correlations, sensitivity, cross-reactivity, interference, precision) evaluate the performance of the VIDAS CKMB assay itself, independent of human interpretive input beyond standard laboratory practices for running the assay. The device provides a quantitative result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Analytical Reference / Predicate Device Comparison:
- For correlation, the predicate device (Ciba-Corning Magic Lite CK-MB assay) served as a reference.
- For sensitivity, cross-reactivity, interference, and precision, the ground truth is established by the known concentrations in control samples, precisely prepared interference matrices, and the inherent analytical capabilities of the assay system designed to measure a specific analyte. The calibrator also plays a role in establishing the measurement scale.

8. The sample size for the training set

Not applicable / Not specified: This K962549 Summary describes the validation of a laboratory immunoassay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device typically involves the development and optimization of reagents, antibodies, and the instrument's detection algorithms, which isn't described as a discrete "training set" size in this document.

9. How the ground truth for the training set was established

Not applicable / Not specified: As mentioned above, this is an immunoassay validation, not an AI development report. The "ground truth" for the development of such an assay would likely involve extensive chemical and biological characterization of reagents and numerous experiments to optimize assay parameters. This information is not typically part of a 510(k) summary.

Summary

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.