(63 days)
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K/DEN number not provided.
No
The summary describes a laboratory assay for measuring a specific enzyme concentration and does not mention any AI/ML components or related concepts like image processing, training/test sets, or complex algorithms beyond standard analytical methods.
No
The device is an assay for determining the concentration of a specific enzyme in serum or plasma, which is used for diagnostic purposes, not for treating a condition.
Yes
The device "determines the concentration of creatine kinase MB isoenzyme in serum or plasma," which is a measurement used for diagnostic purposes (e.g., to assess cardiac damage).
No
The device is an in vitro diagnostic (IVD) assay that measures the concentration of a substance in a biological sample (serum or plasma). This involves chemical reagents and likely a physical instrument (the VIDAS instrument) to perform the assay, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA)." This is a measurement performed on biological samples taken from the body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description reiterates the measurement of a substance in serum or plasma, which are biological fluids.
- Performance Studies: The performance studies describe analytical performance characteristics like sensitivity, cross-reactivity, interfering substances, and precision, which are typical evaluations for IVD assays.
The core function of the device is to analyze a biological sample outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA).
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
- Study Type: Sensitivity, Cross-reactivity, Interfering Substances, Precision/Reproducibility
- Sensitivity: The VIDAS CKMB assay is designed to measure creatine kinase MB levels between 0.8 ng/ml and 300 ng/ml. The lowest measurable level of creatine kinase MB (assay sensitivity) that can be distinguished from zero with 95 % probability using the VIDAS assay is 0.8 ng/ml.
- Cross-reactivity: Specificity studies demonstrate that the antibodies used in the VIDAS CKMB assay is specific for Creatine Kinase MB isoform. No crossreactivity is seen with isoforms BB and MM.
- Interfering Substances: No interference in VIDAS CKMB assay performance was seen with serum collected in dry glass tubes with glyceroled cap, tubes containing a separating gel, siliconized tubes, and non-siliconized tubes, tubes containing EDTA and tubes containing heparin. No interference in the VIDAS CKMB assay performance was seen with the range of concentrations of hemoglobin, lipids, or bilirubin tested.
- Precision/Reproducibility:
- Intra-assay precision studies showed coefficients of variation ranging from 3.2 % to 6.2 % over the reportable range of the assay.
- Inter-assay reproducibility over an eight-week time period yields coefficients of variation that do not exceed 7.2 %.
- Inter-assay, inter-instrument reproducibility for five different serum samples in nine assays on different instruments yields coefficients of variation that do not exceed 16.7 %.
- Correlations (Comparison with Predicate): Comparison of the VIDAS CKMB assay with the Ciba-Corning Magic Lite CK-MB assay yields a line with the equation y = 0.83 x + -0.656 and a correlation coefficient of 0.97.
Key Metrics
- Correlation Coefficient: 0.97 (compared to predicate)
- Sensitivity: 0.8 ng/ml
- Intra-assay Coefficient of Variation: 3.2% to 6.2%
- Inter-assay Coefficient of Variation: ≤ 7.2%
- Inter-assay, inter-instrument Coefficient of Variation: ≤ 16.7%
Predicate Device(s)
Identified as substantially equivalent to the Ciba-Corning Magic Lite CK-MB assay. K/DEN number not provided.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
SUMMARY: Safety and Effectiveness Information for VIDAS CKMB Assay
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.
Safety and effectiveness issues relevant to ELFA methodology for quantitative immunochemistry assays such as those for creatine kinase MB may include poor correlations, poor sensitivity, cross-reactivity, interference, or imprecision.
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- Correlations:
a. Comparison of the VIDAS CKMB assay with the Ciba-Corning Magic Lite CK-MB assay yields a line with the equation y = 0.83 x + -0.656 and a correlation coefficient of 0.97.
- Correlations:
b. The calibrator in the kit ensures that the master curve stored by the VIDAS instrument is valid for the shelf life of that kit. The body of data supports the use of a single calibrator run in duplicate for this purpose.
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- Sensitivity: The VIDAS CKMB assay is designed to measure creatine kinase MB levels between 0.8 ng/ml and 300 ng/ml. The lowest measurable level of creatine kinase MB (assay sensitivity) that can be distinguished from zero with 95 % probability using the VIDAS assay is 0.8 ng/ml.
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- Cross-reactivity: Specificity studies demonstrate that the antibodies used in the VIDAS CKMB assay is specific for Creatine Kinase MB isoform. No crossreactivity is seen with isoforms BB and MM.
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- Interfering Substances
a. No interference in VIDAS CKMB assay performance was seen with serum collected in dry glass tubes with glyceroled cap, tubes containing a separating gel, siliconized tubes, and non-siliconized tubes, tubes containing EDTA and tubes containing heparin.
b. No interference in the VIDAS CKMB assay performance was seen with the range of concentrations of hemoglobin, lipids, or bilirubin tested.
5. Precision/Reproducibility
- a. Intra-assay precision studies showed coefficients of variation ranging from 3.2 % to 6.2 % over the reportable range of the assay.
b. Inter-assay reproducibility over an eight-week time period yields coefficients of variation that do not exceed 7.2 %.
c. Inter-assay, inter-instrument reproducibility for five different serum samples in nine assays on different instruments yields coefficients of variation that do not exceed 16.7 %.
When the VIDAS CKMB assay is used as instructed in the package insert, the above statements are true. The package insert should always be consulted along with the Operator's Manual to ensure that the assay is being performed properly. For additional information, references are listed in the package insert.