(212 days)
The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.
Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.
Assay procedure:
- Incubate the sample with the anti-sirolimus antibody-coated microparticles.
- Add sirolimus alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
This document describes the performance characteristics and acceptance criteria for the Abbott IMx® Sirolimus Microparticle Enzyme Immunoassay (MEIA) test.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate device or implied by comparison) | Reported Device Performance (IMx® Sirolimus MEIA Test) |
|---|---|---|
| Precision | Within-run CV of 2.2 - 7.0%; Between-run CV of 2.2 - 9.2% (CEDIA® Sirolimus Test) | Total imprecision of ≤ 15% through assay range of 5-22ng/ml |
| Recovery | Recovery of 101 - 112% of expected values (CEDIA® Sirolimus Test) | Mean recovery across samples of 90 - 110% of expected values. |
| Dilution Linearity | Recovery of 91 - 106% of expected values for a single high sample (CEDIA® Sirolimus Test) | Mean recovery across samples of 99 - 115% of expected values. |
| Analytical Sensitivity | 4.0 ng/mL (CEDIA® Sirolimus Test) | ≤ 1.5ng/ml |
| Functional Sensitivity | Not listed (CEDIA® Sirolimus Test) | ≤ 2.5ng/ml |
| Specificity for Parent Compound (Cross-reactivity with metabolites) | 11-hydroxy - 44%; 41-O- and 32-O-Demethyl - 73%; Trihydroxy and 41-O-didemethyl - 14%; 41-desmethyl-hydroxy- 10%; Fraction 2 and 7-O-desmethyl - 8.7%; Isomers of fraction 4 - 22%; Hydroxyl - 7%; N-oxide - 15%; Fraction 6 and isomers of Fraction 7 - 4% (CEDIA® Sirolimus Test) | 11-hydroxy-sirolimus - 37%; 41-O-demethyl-sirolimus - 58%; 7-O-demethyl-sirolimus - 63%; 41-O-demethyl-hydroxyl-sirolimus - 6% |
| Co-Administered Drug Interference |
§ 862.3840 Sirolimus test system.
(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.