(71 days)
IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.
IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer.
The provided document is a 510(k) summary for the IMMULITE® C-Reactive Protein device. It details the device, its intended use, and a performance equivalence study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through a method comparison, where the IMMULITE® C-Reactive Protein device is compared to a commercially available immunoradiometric assay (VIRGO).
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (IMMULITE® vs. VIRGO) |
|---|---|
| Demonstrate quantitative measurement of C-reactive protein (CRP) in serum or plasma. | Achieved. |
| Aid in the evaluation of the amount of injury to body tissues. | Achieved (as supported by method comparison to a predicate device with this intended use). |
| Show strong correlation with a legally marketed predicate device. | Linear regression analysis resulted in r = 0.989. |
| Show comparable mean CRP concentrations to a legally marketed predicate device. | IMMULITE Mean: 0.89 mg/dL |
| VIRGO Mean: 0.87 mg/dL | |
| Regression equation demonstrating close agreement with the predicate. | (IMMULITE) = 1.04 (VIRGO) + 0.01 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 97 patient samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the samples were "patient samples," implying human biological material. The clinical study was conducted by the manufacturer, Diagnostic Products Corporation (DPC), prior to the 510(k) submission date of November 1998.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the study described. The "ground truth" for C-reactive protein measurement is established by the accurate and quantitative result obtained from a reference method or a substantially equivalent predicate device, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The study involves quantitative measurement comparison between two devices, not interpretation or adjudication of results by multiple experts.
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 is not a study involving human readers or AI assistance. It's a method comparison for an in vitro diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the IMMULITE® C-Reactive Protein device. The study directly compared the measurements obtained from the IMMULITE® system against those from the VIRGO C-Reactive Protein Kit using patient samples. The results (linear regression, correlation coefficient, and mean values) demonstrate the standalone performance of the IMMULITE® device in relation to the predicate.
7. The Type of Ground Truth Used
The ground truth was established by comparison to a commercially available immunoradiometric assay (VIRGO), which serves as a legally marketed predicate device. The assumption is that the VIRGO kit provides accurate and reliable measurements of CRP, and therefore, strong correlation with VIRGO demonstrates the IMMULITE® system's ability to measure CRP accurately. This is a common approach for demonstrating substantial equivalence for in vitro diagnostics.
8. The Sample Size for the Training Set
Not applicable. This document describes a performance evaluation study (test set), not the development of a machine learning model that would require a distinct training set. The IMMULITE® device is a chemiluminescent enzyme immunometric assay, a biochemical method, not an AI/ML-based device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for a machine learning model is described.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).