(41 days)
Assayed for use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of cardiac Troponin I (cTnl). For in vitro use.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS ECi System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).
The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VITROS Immunodiagnostic Products Troponin I Range Verifiers:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary does not contain performance acceptance criteria or a specific study demonstrating that the device meets those criteria in the traditional sense of a clinical or analytical performance study. This submission is for Range Verifiers, which are quality control materials used to verify the calibration range of an existing immunodiagnostic system (VITROS Immunodiagnostic System) for a specific analyte (Troponin I).
Instead of demonstrating a specific diagnostic performance (like sensitivity or specificity), the submission focuses on substantial equivalence to a predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers) based on physical properties and intended use. The "study" here is essentially a comparison study against the predicate device to establish equivalence, rather than a de novo performance study.
Therefore, many of the requested fields cannot be filled as they pertain to performance studies that were not conducted or reported in this 510(k) summary for this specific type of device (range verifiers).
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit acceptance criteria and corresponding performance metrics for the Troponin I Range Verifiers (e.g., accuracy, precision, stability) are not detailed in this 510(k) summary. The summary states that "Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents." This implies that the 'acceptance' was based on the similarity of the new device to the already-cleared predicate device in terms of its characteristics as range verifiers.
| Acceptance Criterion | Reported Device Performance (as implied by equivalence) |
|---|---|
| Intended Use | For use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of cardiac Troponin I. (Matches predicate in function, differs in specific analyte) |
| Matrix | A base matrix of a freeze-dried human serum-based medium spiked with analyte of human origin. (Similar to predicate's freeze-dried human plasma base spiked with human analyte) |
| Levels | Low and high. (Matches predicate) |
| Safety and Effectiveness | Deemed "safe and effective for the stated intended use" based on substantial equivalence to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission concerns range verifiers, which are control materials, not a diagnostic test device with a "test set" of patient data. The comparison was against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There was no "test set" of patient data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
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 a quality control material, not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
Not applicable. No ground truth for diagnostic performance was established for this device; instead, the ground for approval was an assessment of substantial equivalence to an existing legally marketed device (the VITROS FSH Range Verifiers) based on their intrinsic properties as quality control materials.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of an algorithm or diagnostic model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.