(128 days)
The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
The ARCHITECT Tacrolimus Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of tacrolimus in human whole blood.
The ARCHITECT Tacrolimus Whole Blood Precipitation Reagent is for the extraction of tacrolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Tacrolimus Calibrators) to be tested on the ARCHITECT i System.
The ARCHITECT Tacrolimus assay is a delayed one-step immunoassay for the quantitative determination of tacrolimus in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.
Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.
Sample, assay diluent, and anti-tacrolimus coated paramagnetic microparticles are combined to create a reaction mixture. Tacrolimus present in the sample binds to the anti-tacrolimus coated microparticles. After a delay, tacrolimus acridinium-labeled conjugate is added to the reaction mixture. The tacrolimus on the acridinium-labeled conjugate competes for the available binding sites on the microparticles. Following an incubation, the microparticles are washed, and pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).
An indirect relationship exists between the amount of tacrolimus in the RLUs detected by the ARCHITECT i System optics.
Here's a summary of the acceptance criteria and the study details for the ARCHITECT Tacrolimus assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
This document primarily describes performance characteristics rather than explicit acceptance criteria with defined pass/fail thresholds against which the reported performance is compared. However, the reported performance values implicitly define the level of performance deemed acceptable by the manufacturer for substantial equivalence.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Precision | Total precision %CV ≤ 10% |
| Linearity | Mean recovery within 10% of expected result for diluted samples |
| Functional Sensitivity | Lowest ARCHITECT Tacrolimus assay value exhibiting a 20% CV was 0.8 ng/mL (at the upper 95% confidence limit) |
| Analytical Sensitivity (Limit of Detection) | 0.3 ng/mL at 95% confidence (calculated at two standard deviations above ARCHITECT Tacrolimus Calibrator A) |
| Interference | Average recovery observed during the study ranged from 95% to 105% (with various drugs and potentially interfering compounds) |
| Method Comparison (vs. Predicate Device IMx Tacrolimus II) | Intercept (95% CI): 0.37 (0.00 to 0.68) |
| Slope (95% CI): 0.81 (0.75 to 0.88) | |
| Correlation Coefficient: 0.90 | |
| Method Comparison (vs. LC/MS/MS) | Intercept (95% CI): 0.22 (0.02 to 0.48) |
| Slope (95% CI): 1.07 (1.01 to 1.12) | |
| Correlation Coefficient: 0.92 | |
| Specificity (Cross-Reactivity) | M-I: |
§ 862.1678 Tacrolimus test system.
(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.