(31 days)
OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of lutenizing hormone (LH) in serum or plasma.
OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate soluiton (4-methylumbellifery|phosphate) are sealed in separate wells within the test module.
The provided text describes a 510(k) premarket notification for the OPUS hLH assay. This document focuses on demonstrating substantial equivalence to a legally marketed device rather than establishing new safety and effectiveness through a rigorous clinical trial with explicit acceptance criteria for diagnostic accuracy metrics. Therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set, specific ground truth for training set) is not typically found in this type of submission for in-vitro diagnostic devices.
However, based on the provided text, I can infer and extract information to address your request as best as possible.
Here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For in-vitro diagnostic assays like OPUS hLH, acceptance criteria are often defined by performance characteristics such as precision, accuracy (correlation and recovery), and interference. The submission usually aims to show that the new device performs comparably to or within acceptable ranges relative to the predicate device or established analytical standards.
| Acceptance Criteria Category | Specific Metric (Implicit) | Acceptance Value (Implicit from comparison to predicate/analytical standards) | Reported Device Performance |
|---|---|---|---|
| Precision | Intra-assay %CV | Acceptable low variability (e.g., typically 0.95 indicating strong agreement) | 0.98 |
| Slope | Close to 1 (e.g., 0.9-1.1) | 1.06 | |
| Y-intercept | Close to 0 (e.g., -5 to 5) | 1.06 | |
| Accuracy (Recovery) | Percent Recovery | Within a generally accepted range (e.g., 90-110%) | 95.3% to 98.1% |
| Interference | Cross-reactivity | Low or negligible (e.g., |
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.