(127 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders.
The Tina-quant Complement C4 Test System is based on the activation of the complement system which takes place via a classical and alternative route. Complement factor C4 participates in activation by the classical route. Human C4 forms a precipitate with a specific antiserum which is determined turbidimetrically.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Tina-quant Complement C4 ver.2 Test System:
This document is a 510(k) summary for a diagnostic test, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might find for a novel therapeutic device. Therefore, some of the requested information (like expert qualifications, adjudication methods, MRMC studies, and detailed ground truth for training) is not explicitly present or directly applicable in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated for substantial equivalence to a predicate device, focusing on analytical performance rather than a specific clinical outcome with acceptance criteria. The "acceptance criteria" here are implied by the comparison to the predicate's performance specifications.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Modified Tina-quant Complement C4 ver.2) | Explanation/Comment |
|---|---|---|
| Intended Use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. | The intended use is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Indication for Use | Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders. | The indication for use is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Analyzer | COBAS Integra analyzers | The analyzer is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Sample Type | Human serum and plasma | The modified device expands the sample type to include "plasma" in addition to "human serum" used by the predicate. This is a modification but considered substantially equivalent as assays often perform similarly on serum and plasma for many analytes. |
| Analytical Sensitivity (Predicate K951595): 0.012 g/L (1.2 mg/dL) | Analytical Sensitivity (Modified Device): 0.04 g/L (4 mg/dL) | The modified device has a higher analytical sensitivity (i.e., a less sensitive detection limit) than the predicate. This is a change, but likely deemed acceptable within the context of clinical utility and substantial equivalence. The document doesn't provide a specific acceptance criterion for deviation from the predicate's sensitivity, but typically a less sensitive assay would need to retain clinical validity for its intended use. |
| Measuring Range (Predicate K951595): 0.06-0.9 g/L (6-90 mg/dL) | Measuring Range (Modified Device): 0.04-1.35 g/L (4-135 mg/dL) | The modified device has a wider measuring range (both lower and higher than the predicate). This is generally a beneficial change, indicating improved analytical capability, assuming accuracy and precision are maintained across this wider range. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for any specific test set related to validation studies. It focuses on the descriptive comparison to the predicate device.
The data provenance is not specified. For in vitro diagnostic devices, studies typically involve human serum and/or plasma samples, which could be collected prospectively or retrospectively from various geographical locations. However, this detail is not present in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For a diagnostic test like C4, the "ground truth" for analytical performance (sensitivity, measuring range) is established through laboratory methods and reference materials, not typically by expert interpretation of individual cases. If clinical correlation studies were performed, expert medical opinion might be involved, but this document does not detail such studies.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary, as it's not relevant for demonstrating analytical performance through comparison to a predicate device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor would it be expected for this type of in vitro diagnostic device (a quantitative immunological assay for C4). MRMC studies are typically performed for imaging devices or other tools where human readers interpret complex data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the testing described implicitly represents a "standalone" performance evaluation. The Tina-quant Complement C4 ver.2 Test System is an automated in vitro diagnostic assay. Its performance (analytical sensitivity, measuring range, etc.) is measured directly by the instrument, without human interpretation of the primary data output. Human "in-the-loop" would involve clinicians interpreting the numerical results, but the device's performance itself is standalone.
7. The Type of Ground Truth Used
For the analytical performance metrics (analytical sensitivity, measuring range), the ground truth is established through:
- Reference materials/calibrators: Known concentrations of C4 used to calibrate the assay and determine its range.
- Performance characteristics of the predicate device: The predicate's established performance serves as the benchmark against which the modified device is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
The provided 510(k) summary does not specify a "training set" size. For an in vitro diagnostic assay, development and optimization would involve various samples, but this is distinct from "training data" in artificial intelligence/machine learning contexts.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" as understood in AI/ML is not applicable here, the method of establishing ground truth for it is also not applicable. The development and validation of an IVD assay involve rigorous analytical studies with characterized samples and reference materials to establish its performance specifications.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).