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The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.

The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance characteristics and the results obtained for the ADVIA® 1650 Chemistry Myoglobin Assay. Since this is a submission for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the performance levels of the predicate device or generally accepted clinical laboratory standards as guided by CLSI documents. The reported performance of the new device is compared to these.

2. Sample Size Used for the Test Set and Data Provenance:

• Precision:
  • Serum Pool 1: 40 replicates (assayed over 5 days)
  • Control 1, Control 2, Control 3: 80 replicates each (assayed over 20 days)
  • Serum Pool 2, Serum Pool 3, Serum Pool 4: 80 replicates each (assayed over 20 days)
  • Data Provenance: Not explicitly stated, but typically these types of studies are prospective lab studies conducted internally or by contract research organizations (CROs) for the manufacturer. The document doesn't mention country of origin or if samples were from specific patient populations, implying a general laboratory setting for assay validation.
• Linearity/Assay Reportable Range: Nine intermediate levels were created from low and high serum pools, plus two additional low levels. The total number of samples is not explicitly given but would be at least 11.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared serum pools.
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • LoB: 160 replicates of "zero" serum pool.
  • LoD/LoQ: Several serum pools with myoglobin concentration up to 4 x LOD level. (Exact number not specified for these pools).
  • Data Provenance: Not explicitly stated, likely laboratory-prepared or confirmed serum pools.
• Method Comparison (Serum): 71 serum samples. One sample was removed.
  • Data Provenance: Not explicitly stated, but typically these are human patient samples. The country of origin is not specified, and it's not stated whether they were retrospective or prospectively collected for the study, but typically for method comparison, they would be prospectively selected from a relevant patient population.
• Matrix Comparison (Plasma): 64 plasma samples.
  • Data Provenance: Similar to serum comparison, likely human patient samples. Country/retrospective/prospective not specified.
• Analytical Specificity (Interference): Test samples at specific myoglobin concentrations (50, 100, 400 ng/mL) were spiked with various interferents. The number of samples for each interferent type and concentration is not explicitly given but implies multiple measurements.
  • Data Provenance: Not explicitly stated, likely laboratory-prepared spiked samples using various concentrations of human physiological interferents.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This device is a quantitative immunological test system for measuring myoglobin. The "ground truth" for the test set is established by the predicate device (ADVIA Centaur Myoglobin Assay), which is itself a legally marketed device. There is no explicit mention of human experts establishing a "ground truth" for individual patient samples in the way it might be done for an imaging device (e.g., radiologists). The performance is assessed against an established analytical reference method (the predicate).

4. Adjudication Method:

• Not applicable in the typical sense for a diagnostic imaging or clinical decision support device where human experts adjudicate. For analytical assays, the "adjudication" is inherent in the analytical method comparison and statistical analysis against the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation systems where human readers are making diagnoses. This device is an in vitro diagnostic (IVD) assay that provides a quantitative measurement, not an interpretation by a human reader.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, the entire performance evaluation described (precision, linearity, LoB/LoD/LoQ, method comparison, interference) is a standalone (algorithm only) performance study. The ADVIA® 1650 Chemistry Myoglobin assay is an automated system that performs the measurement without direct human interaction in the analytical process after sample loading.

7. Type of Ground Truth Used:

• The primary "ground truth" used for evaluating the new device's performance is the results obtained from the predicate device (ADVIA Centaur Myoglobin Assay) and, for basic analytical characteristics like LoB/LoD/LoQ, established analytical methodologies and industry standards (CLSI guidelines). For interference, the ground truth is the absence of interfering substances, and deviations are measured against that.

8. Sample Size for the Training Set:

• This 510(k) summary is for an in vitro diagnostic (IVD) assay, not a machine learning or AI model in the typical sense that requires explicit "training data" in the submission. The methods (e.g., latex-particle-enhanced immunoturbidimetric) are based on established chemical and immunological principles. Therefore, there is no specific "training set" sample size mentioned or generally applicable in the context of such an IVD submission. The assay's parameters would have been optimized during its development phase, but these aren't typically documented as a "training set" in a 510(k).

9. How the Ground Truth for the Training Set Was Established:

• As there is no "training set" specified in the context of an AI/ML model for this IVD assay, this question is not applicable. The "ground truth" for developing and optimizing such an assay would be based on fundamental chemical/immunological principles and experiments to ensure accurate and precise measurement of myoglobin concentrations.

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