(36 days)
The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The Tina-Quant® Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. In this immunoturbidimetric method, latex-bound anti-myoglobin antibodies react with antigen in the sample to form an antigen/antibody complex which after agglutination can be determined turbidimetrically. The calibrator is C.f.a.s. Myoglobin and the recommended control material is the Myoglobin Control Set.
The Tina-Quant® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. The device aids in the rapid diagnosis of heart and renal disease.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device, performance metrics like precision, measuring range, and lower detection limit are key acceptance criteria. The submission largely compares the performance of the new device to its predicate device rather than explicitly stating specific acceptance criteria thresholds. However, we can infer some criteria from the presented "Within-run precision" and "Between-run precision" values. The method comparison also serves as a crucial criteria, demonstrating agreement with the predicate.
| Characteristic | Acceptance Criteria (Inferred/Compared to Predicate) | Reported Device Performance (Tina-Quant® Myoglobin Gen.2 Test System) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate: quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. | Quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Indications for Use | Substantially equivalent to predicate: Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. | Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. |
| Assay Principle | Substantially equivalent to predicate: Immunoturbidimetry. | Immunoturbidimetry. |
| Instrument Compatibility | Applied to Hitachi family and Integra family analyzers. (Improved compared to predicate which was Hitachi family only). | Hitachi family (including cobas c6000 series) and Integra family analyzers. |
| Reagent Stability (On-board) | Improved/equivalent to predicate's 28 days at 2-8 °C. | 12 weeks opened and refrigerated. (Significantly improved) |
| Reagent Composition | Minor variations in stabilizers in R1, different procedure for coating latex with antibody in R2, but using the same antibody as predicate. Overall, composition should not negatively impact performance. | R1: same except for minor variations in stabilizers; R2: Same antibody but different procedure for coating latex with antibody. |
| Measuring Range | Equivalent or improved compared to predicate (3-560 ug/L, with extended range 3-4500 ng/mL). | Hitachi 902: 30-580 ug/L. Other Hitachi: 20-580 ug/L, 20-5800 ug/L with extended measuring range. (Wider extended range on "Other Hitachi" vs predicate, but higher lower end on Hitachi 902) |
| Lower Detection Limit | Equivalent or lower than predicate (3 ug/L). | Hitachi 902: 10000 ug/L). (Comparable/expanded data on specific interferents, and new pharmaceutical interference data). |
| Method Comparison (Regression) | Demonstrate strong correlation (high 'r' value) and agreement (slope near 1, intercept near 0) with the predicate device using Passing-Bablok regression. | y = Tina-Quant® Myoglobin Gen.2, x = Tina-Quant Myoglobin. Passing-Bablok results: y = 1.016x + 4.3; T = 0.961; r = 0.992. (Strong correlation and good agreement with a slight positive bias and slope slightly above 1). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in the traditional sense of a clinical validation study with patient samples. The performance data presented (precision, measuring range, detection limit, interference, method comparison) come from internal validation studies.
- Precision:
- Within-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates or runs for each concentration.
- Between-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates, runs, or days.
- Method Comparison: The Passing-Bablok regression shows
r = 0.992, indicating a strong correlation. However, the exact number of samples (n) used for this comparison is not provided. - Interference: "No interference from 18 commonly used pharmaceuticals." The number of samples/tests for each interfering substance is not specified.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's an in-vitro diagnostic device submission, the data is typically generated in a controlled laboratory setting (prospective) by the manufacturer, Roche Diagnostics, which is based in Indianapolis, IN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to immunodiagnostic assays like the Tina-Quant® Myoglobin Gen.2 test system. The "ground truth" for quantitative assays is established by reference methods or by the predicate device (as seen in the method comparison). There are no human "experts" establishing a subjective ground truth for myoglobin concentration. The "ground truth" concentrations are determined by the predicate device or a reference method.
4. Adjudication Method for the Test Set
Not applicable for a quantitative in-vitro diagnostic device measuring a biomarker. The measurements are objective numerical values, not subjective interpretations requiring adjudication.
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 device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human "readers" or interpretations in the way an MRMC study evaluates.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone algorithm/test system. It provides a quantitative result without direct human interpretation of complex images or signals. The "algorithm" is the immunoturbidimetric assay itself, which is performed by automated clinical chemistry analyzers. The performance data presented (precision, measuring range, method comparison) are inherently "standalone" performance metrics of the diagnostic test system. The FDA 510(k) clearance process reviews the test system's performance against established criteria and comparison to a predicate device.
7. The Type of Ground Truth Used
For method comparison, the "ground truth" was the measurements obtained from the predicate device, Tina-Quant® Myoglobin Test System (K972513). The regression equation y = 1.016x + 4.3 where x is the predicate's result, indicates this comparison. For other performance characteristics like precision, the "ground truth" is typically the known concentration of controls or calibrators used in the experiments.
8. The Sample Size for the Training Set
Not applicable. This is a traditional immunodiagnostic assay, not a machine learning or AI-based device that requires a "training set" in that context. The "training" of the assay refers to its development and optimization based on chemical and biological principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense. The optimization and validation of the assay's reagents and methods during development would rely on known myoglobin standards and reference methods to ensure accuracy and precision.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).