(305 days)
Reagent Kit:
The ARCHITECT Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and EDTA plasma.
The ARCHITECT Galectin-3 assay may be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF). The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.
Calibrators:
The ARCHITECT Galectin-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma.
Controls:
The ARCHITECT Galectin-3 Controls are for the verification of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma.
The ARCHITECT Galectin-3 assay is a two-step immunoassay for the guantitative determination of galectin-3 in human serum or EDTA plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample and M3/38 anti-galectin-3 coated paramagnetic microparticles are combined. Galectin-3 present in the sample binds to the anti-galecin-3 coated microparticles. After washing, 87B5 anti-galectin-3 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).
A direct relationship exists between the amount of galectin-3 in the sample and the RLUs detected by the ARCHITECT i System optics. The kit is composed of the following:
ARCHITECT Galectin-3 Reagent Kit (5P03)
ARCHITECT Galectin-3 Calibrators (5P03-01)
ARCHITECT Galectin-3 Controls (5P03-10)
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Precision | ≤ 10% Total CV for samples 4.0 to 114.0 ng/mL | Total precision for one lot: ≤ 5.8% for all samples. Total reproducibility for two lots: ≤ 4.7% for all samples. (Meets criteria) |
| Linearity/Reportable Range | Based on +/-10% deviation from linearity (%DL) | Linear range: 5.5 to 103.1 ng/mL. (Meets criteria) |
| Detection Limit (LoQ) | ≤ 4.0 ng/mL | LoB: 1.0 ng/mL; LoD: 1.1 ng/mL; LoQ: 2.8 ng/mL. (Meets criteria, as LoQ is ≤ 4.0 ng/mL) |
| Analytical Specificity | Percent cross-reactivity with other human recombinant galectin and collagen proteins 17.8 ng/mL), compared with galectin-3 levels in the low risk category ( 17.8 ng/mL) = 1.753 (95% CI: 1.265 – 2.427), which is statistically significant (p-value implicitly |
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”