Search Results

The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin, sodium heparin or K2 EDTA) on the Atellica® CH Analyzer.

Measurements from Atellica® CH High Sensitivity C -Reactive Protein 2 (hCRP2) may be used as an aid in identification of individuals at risk for future cardiovascular disease. Measurement of hCRP2, when used in coniunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.

Device Description

The Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is used for the quantitative determination of C-Reactive protein in human serum and plasma using the Atellica CH analyzer. This device is two ready-to-use reagent packs consisting of 23.1mL Phosphate buffer, polidocanol (1.9g/L), and sodium azide (0.1%) in Pack 1 and 12.3mL Mouse anti-CRP monoclonal antibodies (13mg/L), polystyrene particles (1g/L), human albumin (0.05%) and sodium azide (<0.1%) in Pack 2. This product consists of two (2) kits consisting of 360 tests each for a total of 720 tests.

Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

The system automatically performs the following steps:

1. For serum/plasma, dispenses 30 µL of primary sample and 90 µL of Atellica CH Diluent into a dilution cuvette.
1. Dispenses 100 µL of Reagent 1 into a reaction cuvette.
1. Dispenses 3 µL of pre-diluted sample into a reaction cuvette.
1. Dispenses 45 µL of Reagent 2 into a reaction cuvette.
1. Mixes and incubates the mixture at 37°C.
1. Measures the absorbance after Reagent 2 addition.
1. Reports results.

Atellica CH High-Sensitivity C-Reactive Protein 2 (hCRP2) assay is used in conjunction with the Atellica CH Analyzer and Atellica CH Protein 2 Calibrator (PROT2 CAL)

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Device: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Design Goal)	Reported Device Performance
Detection Capability
Limit of Blank (LoB)	LoB ≤ Limit of Detection (LoD)	0.06 mg/L
Limit of Detection (LoD)	LoD ≤ Limit of Quantitation (LoQ)	0.11 mg/L
Limit of Quantitation (LoQ)	≤ 0.16 mg/L (with < 20% deviation)	0.16 mg/L
Precision	Undefined numerical criteria provided, but demonstrated across various concentration levels.	Repeatability (CV%) range: 0.5% - 2.1%. Within-Lab (CV%) range: 0.8% - 2.5%. (Based on 80 replicates per specimen)
Reproducibility	Undefined numerical criteria provided, but demonstrated across multiple sites/instruments/lots.	Total Reproducibility (CV%) range: 0.9% - 2.5%. (Based on 225 replicates per specimen)
Assay Comparison	Correlation coefficient (r) ≥ 0.950, Slope of 1.00 ± 0.05 (compared to BN ProSpec CardioPhase hsCRP)	r = 0.999, Slope = 0.96 (from y = 0.96x + 0.03 mg/L). Meets criteria for correlation and slope (0.96 is within 1.00 ± 0.05).
Specimen Equivalency	Undefined numerical criteria for regression, but strong correlation visually implied acceptable.	Sodium Heparin vs. Serum: y = 1.07x - 0.02 mg/L (r = 0.998) Potassium EDTA vs. Serum: y = 0.97x - 0.03 mg/L (r = 0.997) Lithium Heparin vs. Serum: y = 1.07x - 0.03 mg/L (r = 0.998). Strong correlations (r values near 1) indicate good equivalency.
Interferences (HIL)	≤ 10% interference from hemoglobin, bilirubin, and lipemia.	Hemoglobin: 0% to 4% bias at 10 g/L Bilirubin, conjugated: -1% bias at 684 µmol/L Bilirubin, unconjugated: -1% to 0% bias at 684 µmol/L Lipemia (Intralipid®): -7% to -4% bias at 30 g/L. All biases are ≤ 10%.
Non-interfering Substances	≤ 10% bias for Rheumatoid factors.	Rheumatoid factors: -1% to 0% bias at 500 IU/mL. All biases are ≤ 10%.
High-Dose Hook Effect	Not explicitly stated as a numerical criterion, but designed to avoid hook effect within reportable range.	High C-reactive protein levels as high as 1300.00 mg/L will read > 9.50 mg/L (which is the upper limit of the measuring interval). This indicates the assay correctly identifies concentrations above the measuring interval and avoids a hook effect within the intended range.

2. Sample Size Used for the Test Set and Data Provenance:

Detection Capability:
- LoB: 3 reagent lots, 6 blank samples, 5 replicates per sample = 90 determinations.
- LoD: 495 determinations (270 blank, 225 low-level replicates) using 3 reagent lots.
- LoQ: 5 native low analyte serum samples, 5 replicates each = 25 determinations.
Precision (Repeatability/Within-Lab): 80 replicates per specimen (5 serum samples + 1 QC, total 6 specimens).
Reproducibility (Multi-site/Multi-lot): 225 replicates per specimen (5 serum samples + 3 QCs, total 8 specimens).
Assay Comparison (Method Comparison): 100 patient samples.
Specimen Equivalency: 55 patient samples for each specimen type (Sodium Heparin, Potassium EDTA, Lithium Heparin).
Interferences (HIL & Non-interfering Substances): Not explicitly stated, but typically involves a smaller number of samples spiked with interferents at multiple analyte concentrations.

Data Provenance: Not explicitly stated, but the sample types are human serum and plasma, diluted with Atellica CH diluent (saline) or enriched as needed. This usually implies a mix of commercially sourced and/or in-house collected human samples. There is no information regarding the country of origin or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This device is an in vitro diagnostic test for C-Reactive Protein (CRP) concentration. The "ground truth" for a quantitative assay like this is typically established by:

Reference methods/standards (e.g., ERM-DA474/IFCC for CRP, as mentioned).
Comparative analysis against a legally marketed predicate device (BN ProSpec CardioPhase hsCRP).
Standard preparation and gravimetric/volumetric assurance for spiked samples or known concentrations.

Therefore, "experts" in the sense of clinical reviewers or pathologists establishing a diagnostic ground truth is not applicable here. The accuracy of the measurements is compared against established analytical criteria and methodologies.

4. Adjudication Method for the Test Set:

Not applicable in the context of this type of IVD performance study, as there is no subjective interpretation requiring adjudication of results from different observers. The output is a quantitative value (mg/L).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic tests where human interpretation plays a significant role and AI assistance might influence reader performance. For a quantitative in vitro diagnostic assay like high-sensitivity CRP, the measurement is automated and objective.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies described (Detection Capability, Precision, Reproducibility, Assay Comparison, Specimen Equivalency, Interferences, High-Dose Hook Effect) are all standalone performance evaluations of the Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay as an automated laboratory test on the Atellica CH Analyzer. The device is intended for in vitro diagnostic use, meaning it operates without direct human interpretive input beyond running the test and reading the numerical result.

7. The Type of Ground Truth Used:

The ground truth for this device is established through:

Analytical Standards: The assay is traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference material ERM-DA474/IFCC, which serves as a primary ground truth for CRP concentration.
Predicate Device Comparison: The performance is compared against a legally marketed predicate device (BN ProSpec CardioPhase hsCRP assay), where the predicate's measurements serve as a comparative standard.
Reference Intervals: Expected values for cardiovascular risk prediction are based on established clinical guidelines (Pearson TA et al., 2003).
Spiked Samples: For interference studies, known concentrations of interfering substances are added to samples, and the known concentration of the analyte is the ground truth.

8. The Sample Size for the Training Set:

Not explicitly stated in the 510(k) summary. For a device like this, the "training set" would refer to the samples used during the development and optimization phase of the assay (e.g., reagent formulation, calibration curve development), rather than a machine learning training set. The approval document focuses on the validation or test sets.

9. How the Ground Truth for the Training Set Was Established:

Similar to point 7, the ground truth for potential "training" (development/optimization) would involve analytical standards (like ERM-DA474/IFCC), purified CRP, and well-characterized human serum/plasma samples, often with known CRP concentrations determined by reference methods or gravimetric/volumetric preparation. The goal would be to develop a robust assay that accurately measures CRP across its analytical range.

Ask a Question

Ask a specific question about this device

Page 1 of 1