(57 days)
Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.
Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.
Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.
This document describes the Elecsys ACTH Immunoassay, CalSet, CalCheck, and PreciControl ACTH. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria with acceptance criteria and a study to prove it.
However, based on the provided text, we can extract the reported performance of the device and compare it to the predicate device, which implicitly serves as a benchmark for "acceptance." The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for the Elecsys ACTH system, but rather presents its performance characteristics and compares them to legally marketed predicate devices to establish substantial equivalence.
Here's an attempt to structure the information in the requested format, acknowledging the limitations of the provided text which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
Since no explicit "acceptance criteria" are given for the Elecsys ACTH Immunoassay, the table below presents its reported performance characteristics and compares them to the predicate Immulite ACTH assay, as demonstrating comparable performance to a legally marketed device is the basis for 510(k) clearance. The implied "acceptance criteria" for a 510(k) submission is that the new device performs acceptably and substantially equivalently to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Elecsys ACTH Immunoassay Reported Performance |
|---|---|---|
| Measuring Range | 5 – 1,250 pg/mL | 1 – 2,000 pg/mL |
| Precision (Intra-assay/Within-run) |
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.