(42 days)
The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer.
The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration.
The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated microparticles. A six-level set of QMS® Vancomycin Calibrators (A through F) i
Here's a summary of the acceptance criteria and study findings for the QMS® Vancomycin assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for QMS® Vancomycin Assay
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for all tests. Instead, it presents study results and implies that the observed performance characteristics were deemed acceptable for substantial equivalence to the predicate device. For the purpose of this table, "Acceptance Criteria (Implied)" are derived from the overall goal of demonstrating equivalency or typical performance expectations for such assays, and "Reported Device Performance" are the results presented in the summary.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable within-run, between-run, between-day, and total CVs for clinical use. | Low Control (7.57 µg/mL): Total CV 8.84% |
| Mid Control (20.79 µg/mL): Total CV 6.21% | ||
| High Control (33.65 µg/mL): Total CV 5.12% | ||
| Accuracy (Recovery) | Mean Percent Recovery close to 100% across the assay range (e.g., 90-110%). | Mean Percent Recovery: 99.61% (ranging from 91.11% to 110.61% across 9 theoretical concentrations from 5.00 to 100.00 µg/mL). |
| Linearity (Dilution) | Mean Percent Recovery close to 100% across the dilution range. | Mean Percent Recovery: 100.17% (ranging from 95.71% to 107.20% across 5 theoretical concentrations from 2.50 to 75.00 µg/mL). |
| R2= 0.9998 (from scatter plot). | ||
| Sensitivity (LDD) | Least Detectable Dose (LDD) must support the claimed lower limit of detection. | LDD: 0.46 µg/mL, supporting a claim of 0.55 µg/mL. |
| Specificity (CDP-I) | Cross-reactivity with the vancomycin metabolite CDP-I should be low (e.g., |
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.