(122 days)
The Audit™ MicroCV™ Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB. Myoglobin, and Troponin I (Tnl) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When Audit™ MicroCVTM Cardiac Markers Linearity Set is used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the analyzers indicated in the labeling. The Audit™ Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCV™ Cardiac Markers Linearity Set is a 5 level quality control solution set containing CKMB, Myoglobin, and Tnl analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI analytes. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
The provided text details a 510(k) premarket notification for the Audit™ MicroCV™ Cardiac Markers Linearity Set. This is a quality control material, not a medical device in the typical sense that uses AI, therefore most of the requested information regarding acceptance criteria for device performance, clinical studies, sample sizes, expert involvement, and ground truth establishment is not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing technical characteristics and stability, rather than establishing specific performance metrics for diagnostic accuracy.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Audit™ MicroCV™ Cardiac Markers Linearity Set) |
|---|---|---|
| Intended Use | To confirm proper calibration, linear operating range, and reportable range for various general chemistry analytes, and for quality control, proficiency testing, and CLIA-directed calibration verification for these analytes. | To confirm the proper calibration, linear operating range, and reportable range of CKMB, Myoglobin, and TnI analytes. For quality control purposes when a linear relationship between five levels for CKMB, Myoglobin, and TnI analytes is demonstrated. |
| Number of Levels per Set | 5 | 5 |
| Contents | 5 x 5mL | 5 x 1mL |
| Matrix | Human Serum | Human Serum |
| Type of Analytes | Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO₂, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, Lactate, LDH, LDL Cholesterol, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, and Uric Acid. | CKMB, Myoglobin, and Troponin I (TnI) |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C for 48 months | 2 to 8° C for 18 months |
| Open Bottle Stability | 7 days at 2 to 8° C | 5 days at 2 to 8° C |
Key takeaway on Acceptance Criteria: The acceptance criteria for this device are primarily demonstrated through substantial equivalence to the predicate device, K042318 (Audit™ MicroCV™ General Chemistry Linearity Set), in terms of intended use, number of levels, matrix, form, and the principle of linearity. The reported performance aligns with these characteristics, with explicit differences noted in analytes, stability durations, and contents volume. The submission does not define specific numerical performance thresholds (e.g., accuracy, precision) for the analytes within the linearity set itself, as its purpose is to verify the linearity of separate diagnostic analyzers.
Regarding the Study That Proves the Device Meets Acceptance Criteria:
The provided document describes the basis for FDA clearance (510(k)) which relies on demonstrating substantial equivalence. The "study" in this context refers to the data generated to support the claims of stability and the comparison to the predicate.
- Stability Studies: The document explicitly mentions that "Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Cardiac Markers Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
- Open Vial Stability: 5 days when stored tightly capped at 2-8 C.
- Shelf Life: 18 months at 2 - 8º C.
- Note: Real time studies are ongoing to support the shelf life of this product."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. For stability studies of linearity sets, this typically involves multiple lots, multiple vials per lot, and testing at various time points.
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd. in Carlsbad, CA, USA. The data is retrospective in that it was collected prior to submission, but the "real-time studies are ongoing" comment indicates some prospective elements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a linearity set (a quality control material). Its "ground truth" is defined by its manufacturing process and the characterized concentrations of the analytes within each level. It is not a diagnostic device requiring expert interpretation of results for clinical ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As a quality control material, there is no clinical "test set" in the sense of patient data requiring adjudication. The characterization would follow standard analytical chemistry and quality control protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The Type of Ground Truth Used
- For the stability studies, the "ground truth" for the analyte concentrations at different time points would be established by analytical measurements using validated methods and reference materials (if applicable) at the time of manufacture and at various points during its shelf life. Linearity would be assessed by comparing the measured values across the five levels to an expected linear relationship.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set for an AI/ML algorithm is involved.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.