(147 days)
In vitro diagnostic reagents for the quantitative determination of a2-macroglobulin in human serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of a>-macroglobulin may aid in the diagnosis of blood clotting or clot lysis disorders.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The provided text describes a 510(k) submission for the "N Antisera to Human α2-Macroglobulin" device. However, it only presents a single performance characteristic related to the device, with no mention of specified acceptance criteria.
Therefore, the following information is based on the limited data available and significant gaps exist due to the absence of the requested details in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Correlation coefficient of 0.98 for equivalent performance between serum and heparinized plasma. |
2. Sample Size Used for the Test Set and Data Provenance
The text states, "To demonstrate equivalence in measurement between serum and heparinized plasma, a method comparison was performed." It does not specify the sample size used for this study or the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study described is a method comparison for an in vitro diagnostic reagent, not a diagnostic imaging device requiring expert interpretation of images for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. The study described is a method comparison for an in vitro diagnostic reagent. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting diagnostic images or clinical outcomes, which is not applicable here.
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. This type of study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks (e.g., image interpretation), which is not the function of this in vitro diagnostic reagent.
6. If a Standalone Performance Study was Done
The reported "correlation coefficient of 0.98" refers to a comparison between serum and heparinized plasma samples using the device. While this demonstrates the device's consistency across different sample types, it is a method comparison for equivalence, not a standalone performance study against a definitive gold standard for α2-macroglobulin measurement. The document states it is "substantially equivalent to the N Antisera to Human α2-Macroglobulin currently marketed (K860894)," implying its performance is compared to an existing device rather than assessed in absolute terms.
7. The Type of Ground Truth Used
The ground truth used for the method comparison appears to be the measurements obtained from the same N Antisera to Human α2-Macroglobulin assay, specifically comparing its performance when used with serum versus heparinized plasma. The objective was to demonstrate equivalence in measurement between these two sample types. There is no mention of an external gold standard (e.g., pathology, outcomes data) for the α2-macroglobulin levels themselves, but rather an internal consistency check for different sample matrices.
8. The Sample Size for the Training Set
Not applicable. The device described is an in vitro diagnostic reagent—an immunological test system—not a machine learning or AI-based device that typically requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.