(48 days)
In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.
Acceptance Criteria and Study for N Antisera to Human Complement Factors (C3c, C4)
This submission describes the acceptance criteria and the study that proves the device meets those criteria for the N Antisera to Human Complement Factors (C3c, C4). The primary focus of this submission is to demonstrate equivalence in performance when expanding the intended use to include heparinized or EDTA plasma as specimen types, in addition to serum.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Serum to Plasma Equivalence | Correlation coefficient between serum and heparinized plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
| Serum to Plasma Equivalence | Correlation coefficient between serum and EDTA plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the test set (number of patient samples) is not explicitly stated in the provided document. The study performed "method comparisons" to demonstrate equivalence.
The data provenance (country of origin, retrospective or prospective) is not explicitly stated. However, given it's a 510(k) submission for a device marketed by Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), it's likely a controlled, prospective validation study conducted in a laboratory setting, potentially using samples from a relevant patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The ground truth for this device is not established by expert clinical review of images or diagnoses. Instead, the accuracy of the device is assessed by its ability to quantitatively determine complement factors, where established laboratory methods serve as the reference for comparison.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical data (e.g., imaging studies) where multiple experts resolve discrepancies. For quantitative assays like this, agreement is assessed statistically.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not relevant for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. This submission focuses on the analytical performance of a quantitative assay.
6. Standalone (Algorithm Only) Performance Study
This is an in vitro diagnostic assay, not an algorithm or AI system in the traditional sense. The "device" itself is the reagent. Therefore, a "standalone algorithm performance" study is not applicable. The performance is intrinsically linked to the assay's ability to accurately measure the target analytes. The study explicitly focuses on the analytical performance of the assay and its reagents in different sample matrices.
7. Type of Ground Truth Used
The ground truth for the test set was established by comparison to serum measurements using the current, legally marketed N Antisera to Human Complement Factors (C3c and C4) assays.
The study essentially compares the quantitative results obtained from heparinized or EDTA plasma samples with the quantitative results obtained from serum samples (which represent the established "ground truth" or reference for this assay type). The correlation coefficients of 0.98-0.99 indicate that the measurements in plasma are highly consistent with those in serum.
8. Sample Size for the Training Set
This information is not applicable. This device is a reagent for a quantitative diagnostic assay. It does not employ machine learning or AI models that require a "training set" in the conventional sense. The "learning" or optimization of the assay's performance would occur during its initial development and validation stages through extensive analytical testing, not through a "training set" like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of in vitro diagnostic device, as explained in point 8.
§ 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).