(12 days)
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The Access Cortiosol reagents, Access Cortisol Calibrators and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.
This document is a 510(k) summary for a device modification, specifically a change to the directional insert of the Access Cortisol assay. It does not present a new study with acceptance criteria and device performance results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance for a new study. Instead, it highlights revisions made to existing sections of the device's directional insert:
- Revised: 'Analytical Specificity / Interferences' section for cross-reactivity of the assay with substances similar to cortisol.
- Revised: 'Expected Values' section for urine cortisol concentration in 24-hour urine samples determined by extracted and unextracted methods.
Since this is a submission for a change in labeling (directional insert) and not a new device or significant modification requiring fresh performance studies, no new acceptance criteria or reported device performance data in the typical sense are presented. The core assay performance is presumed to be covered by the predicate device's clearance (K954733).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes changes to existing product information, not a new study requiring a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set and ground truth were established as part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was established.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in-vitro diagnostic immunoassay for cortisol levels, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an in-vitro diagnostic immunoassay, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document deals with revisions to "Analytical Specificity / Interferences" and "Expected Values" for an immunoassay. The ground truth for such revisions would typically be established through biochemical and clinical studies relating to the accuracy of cortisol measurement and its physiological ranges, conducted as part of the initial device development and validation (for the predicate device). However, this document does not detail how the revised information was substantiated.
8. The sample size for the training set
Not applicable. This is not a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not a study involving a training set for an algorithm.
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.