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The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The test is carried out by means of the ProciseDx Analyzer.

Measurement of CRP aids in evaluation of injury to body tissues, inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point of care use.

Device Description

The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance energy transfer (FRET) signal to detect and quantify CRP. FRET is a process in which a donor molecule, in an excited state, transfers excitation energy to an acceptor fluorophore when the two are brought into close proximity. Upon excitation at a characteristic wavelength the energy absorbed by the donor is transferred to the acceptor, which in turn emits light energy. The level of light emitted from the acceptor fluorophore is directly proportional to the degree of donor/acceptor complex formation.

The Procise CRP assay format is designed as a competitive format. A monoclonal anti-CRP antibody and exogenous CRP antigen are labeled with donor and acceptor fluorophores, respectively. The monoclonal antibody specific for CRP is labelled with the donor fluorophores and the CRP antigen is labelled with the acceptor fluorophore. Similar to other competitive assay formats, as the concentration of CRP increases a proportional decrease in the signal is observed.

AI/ML Overview

The Procise CRP Assay Kit, ProciseDx Instrument, and ProciseDx Calibration Cartridge (K201256) is a device for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. It is intended to aid in the evaluation of injury to body tissues, infection, and inflammatory disorders.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state "acceptance criteria" in a quantified table for all performance characteristics. Instead, it presents the results of individual studies and implicitly expects them to demonstrate substantial equivalence to the predicate device and meet typical analytical performance standards for in vitro diagnostic devices. Below is a summary of the performance characteristics obtained from the studies. For qualitative criteria like specificity, "No significant interference" serves as the reported performance, implying it met an internal acceptance threshold. For quantitative metrics like precision, the reported values are the performance.

Performance Characteristic	Acceptance Criteria (Implicit/Typical for IVD)	Reported Device Performance (Procise CRP)
Precision (Within-Laboratory)	Typically low Coefficient of Variation (CV%) for various CRP concentrations. Expected to be within acceptable limits for clinical diagnostic use.	Sample 1 (5.9 mg/L): Total SD=0.4, %CV=7.4
Sample 2 (9.2 mg/L): Total SD=0.8, %CV=8.6
Sample 3 (35.5 mg/L): Total SD=1.6, %CV=4.4
Sample 4 (75.1 mg/L): Total SD=4.6, %CV=6.1
Sample 5 (93.5 mg/L): Total SD=6.4, %CV=6.8
Sample 6 (125.6 mg/L): Total SD=10.0, %CV=8.0
Precision (Between-site)	Typically low Coefficient of Variation (CV%) across different sites. Expected to be within acceptable limits for clinical diagnostic use.	Sample 1 (7.27 mg/L): Total SD=0.6, %CV=7.6
Sample 2 (25.3 mg/L): Total SD=2.0, %CV=7.8
Sample 3 (72.7 mg/L): Total SD=6.5, %CV=9.0
QC1 (5.53 mg/L): Total SD=0.6, %CV=10.0
QC2 (48.7 mg/L): Total SD=4.5, %CV=9.3
Linearity	Linear regression R² value close to 1, slope close to 1, and intercept close to 0 within the measuring range.	Range (3.6 - 161.0 mg/L): Slope = 0.99 (95% CI: 0.97 – 1.00), Intercept = 0.05 (95% CI: -0.94 – 1.05), R² = 1.00
Analytical Specificity/Interference	Mean bias

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