Search Results
Found 1 results
510(k) Data Aggregation
(345 days)
BGM Galectin-3 is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or EDTA-plasma by enzyme-linked immunosorbant assay (ELISA) on a microtiter plate platform to be used in conjunction with clinical evaluation as an aid in assessing prognosis of patients diagnosed with chronic heart failure (HF). BGM Galectin-3 is indicated for prescription use only.
BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorbant assay (ELISA) for the quantitative determination of galectin-3 levels in human serum and plasma. BGM Galectin-3 consists of a rat monoclonal anti-mouse galectin-3 antibody coated microtiter plate serving as the solid phase capture antibody and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-human galectin-3 antibody functioning as the liquid phase tracer antibody for detecting bound galectin-3.
In the testing procedure, galectin-3 in the standard, control, or patient specimen binds to the immobilized capture antibody; after a wash step, bound galectin-3 is detected by the addition of HRP-labeled anti-galectin-3 antibody. Following a second wash step, the presence of bound galectin-3 is demonstrated by an enzymatic blue color development resulting from the addition of tetramethylbenzidene (TMB) solution as the substrate. Color development is stopped by adding sulfuric acid, changing the color to yellow. Color intensity is read at an absorbance of 450 nm using a colorimetric reader. The absorbance is proportional to the galectin-3 levels in the samples, and test results of the samples are determined using a calibration curve derived from the standards.
BGM Galectin-3 contains the microtiter plate, reagents, assayed quality control materials and standards required to perform analyses on serum or EDTA-plasma samples.
This document describes the analytical and clinical performance of the BGM Galectin-3™ assay.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but the "Summary of Performance Data" section describes various tests and their outcomes. For clinical performance, the focus is on hazard ratios and cumulative probabilities.
Here's an integrated table derived from the provided text, using reported outcomes as evidence of meeting implicit acceptance criteria:
| Feature / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Internal) | Estimates of within-run, run-to-run, day-to-day and total precision met acceptance criteria. | Within-run imprecision: 2.1-5.7% CV (from 6.1-72.2 ng/mL) |
| Total imprecision: 4.2-12.0% CV (from 6.1-72.2 ng/mL) | ||
| Precision (Clinical Labs) | Results from each CLIA laboratory within acceptable limits for within-run and total imprecision. | Lab A: Within-run CV% 2.9-5.0%, Total CV% 6.0-14.6% |
| Lab B: Within-run CV% 2.3-5.4%, Total CV% 7.2-16.9% | ||
| Lab C: Within-run CV% 3.0-7.3%, Total CV% 5.6-9.4% | ||
| Linearity | Linearity demonstrated across a clinically meaningful range. | Demonstrated between 1.4 and 94.8 ng/mL (R-squared = 0.9985, equation y = 0.9905x - 0.41) |
| Dilution Parallelism | Support for specified dilution. | Supports ten-fold sample dilution only (1:10). Samples > 94.8 ng/mL should not be diluted beyond 1:10. |
| High Dose Hook Effect | No significant hook effect. | No high dose hook effect at galectin-3 levels up to 500 ng/mL. |
| Sample Matrices Equivalence | Equivalence between serum and EDTA-plasma demonstrated. | Strong correlation between matched serum and EDTA-plasma samples (R-squared = 0.96, regression y = 0.96x + 0.72) |
| Detection Limit (LoB/LoD/LoQ) | Defined and characterized according to CLSI EP17-A. | LoB: 0.86 ng/mL |
| LoD: 1.13 ng/mL | ||
| LoQ: 1.32 ng/mL (CV 10.4%) | ||
| Cross-Reactivity | No significant cross-reactivity with specified related substances. | Mean % cross-reactivity at or below 0.3% for galectins 1, 4, 7, 8, 9, 12, collagen I and III (at 500 ng/mL). |
| Interfering Substances | No significant interference (within +/-10%) from specified endogenous and common pharmaceutical substances. | No significant interference: Conjugated Bilirubin (up to 16.8 mg/dL), Unconjugated Bilirubin (up to 40.3 mg/dL), Albumin (up to 12 g/dL), Triglycerides (up to 3000 mg/dL), Cholesterol (up to 747 mg/dL), Creatinine (up to 5 mg/dL), Purified Hemoglobin (up to 500 mg/dL), and 34 common pharmaceutical substances. |
| Interfering Substances (Warning) | Identify substances causing significant interference. | Significant interference: Whole blood cell lysate (hemolyzed specimens contraindicated), Human anti-mouse antibodies (HAMA) (specimens with HAMA contraindicated), Rheumatoid Factor (RF > 50 IU/mL), High levels of gamma globulins (> 2.5 g/dL). |
| Clinical Efficacy (Prognosis) | Galectin-3 levels significantly associated with increased risk of adverse outcomes in HF patients. | Hazard Ratios (Adj.) for > 17.8ng/mL (vs ≤ 17.8ng/mL): |
- All-cause mortality & hospitalization: 1.35-1.46 (p=0.004-0.006)
- Cardiovascular mortality: 1.91-2.33 (p=0.002- 25.9 ng/mL).
These two sets effectively serve as the "training" or "derivation" sets for the clinical interpretation of the assay.
9. How the Ground Truth for the Training Set Was Established:
- Reference Range: Established from 1,099 apparently healthy subjects. "Healthy" implies the absence of known heart disease. The exact methods for confirming "healthy" status are not detailed but would typically involve medical history, physical examination, and possibly other diagnostic tests.
- Cutoff Value Derivation: Derived from 582 individuals with HF. The document implies these cutoffs were determined by analyzing the association between galectin-3 levels and adverse outcomes within this derivation cohort. The specific methodology for deriving these cutoffs (e.g., statistical methods like ROC curve analysis or survival analysis) is not explicitly detailed in this summary, but they are subsequently validated in a separate, larger cohort. "HF" diagnosis would be established by clinical criteria, but the specific validation method for that diagnosis is not given.
Ask a specific question about this device
Page 1 of 1