(238 days)
IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.
The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MP: Magnetic particles coated with mouse monoclonal anti-ACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
- R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative.
- R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
The provided text describes the performance characteristics of the IDS ACTH II assay, which is an automated in vitro diagnostic device for the quantitative determination of ACTH in human K2 and K3 EDTA plasma. The study aims to demonstrate that the device meets the acceptance criteria for various analytical performance parameters.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate column for each test. Instead, it describes the methodology used to determine each performance characteristic and then presents the results. Based on the context and the nature of these studies, the reported values often serve as the demonstrated "performance" which, by the conclusion of the 510(k) summary, are deemed sufficient to support substantial equivalence. For analytical characteristics like Linearity, Interference, and Cross-Reactivity, the document does specify thresholds for acceptable performance.
| Performance Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Analytical Limits | ||
| Limit of Blank (LoB) | (Determined according to CLSI EP17-A) | 0 pg/mL |
| Limit of Detection (LoD) | (Determined according to CLSI EP17-A) | 1 pg/mL |
| Limit of Quantitation (LoQ) | Lowest concentration with within-laboratory precision CV ≤ 20% | 3 pg/mL |
| Precision | (Evaluated according to CLSI EP05-A3) | Repeatability (Within Run/Within Laboratory): CVs for various concentrations range from 0.9% to 14.5% (Within Run) and 1.7% to 26.8% (Within Laboratory). Reproducibility (Between sites/systems): CVs for various concentrations range from 1.2% to 14.4% (Repeatability) and 4.4% to 24.8% (Reproducibility). Reproducibility (Between lots): CVs for various concentrations range from 0.6% to 20.8% (Between-Run), 1.1% to 35.2% (Between-Day), and 3.2% to 50.5% (Reproducibility). |
| Linearity | Allowable Deviation of Linearity (ADL) of ≤±16.3% or ≤±4 pg/mL for concentrations below 20 pg/mL. | The IDS ACTH II is linear across the analytical measuring interval of 4 to 1000 pg/mL, within the allowable deviation of linearity. |
| Analytical Specificity (Interference) | No significant interference: ≤±10% bias (Cholesterol ≤±15%) | No significant interference ( |
§ 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.