(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 <10-15%) | 4.56% to 6.32% |
| Inter-assay %CV | Acceptable low variability (e.g., typically <10-15%) | 4.55% to 5.64% | |
| Accuracy (Correlation) | Correlation Coefficient (r) | Close to 1 (e.g., >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., <5-10% depending on analyte) | <0.6% for hOG and hGH |
| No interference detection | No significant impact on results | TSH, FSH, Prolactin |
2. Sample size used for the test set and the data provenance
- Sample Size for Accuracy (Correlation Study): 143 serum samples.
- Sample Size for Precision Studies:
- Intra-assay: 3 serum pools, 20 replicates each.
- Inter-assay: 3 levels of 2 sets of control sera, assayed in triplicate twice a day for 5 days (total of 30 replicates per level/set).
- Sample Size for Recovery Study: Samples assayed "in replicates of three" for different LH concentrations added to a normal human serum pool.
- Data Provenance: The document does not explicitly state the country of origin. It is prospective testing performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is typically not applicable to an in-vitro diagnostic assay submission of this type. The "ground truth" for the test set in the accuracy correlation study is derived from the results of the already commercially available immunoassay (the predicate device) or by established analytical methods for the recovery and interference studies. It does not involve human expert consensus in the same way an imaging AI algorithm might.
4. Adjudication method for the test set
Not applicable for this type of in-vitro diagnostic device performance study. The comparison is between analytical results.
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 is an in-vitro diagnostic device for measuring a hormone, not an AI-assisted diagnostic imaging or human-in-the-loop system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described (precision, accuracy, interference) represent the standalone performance of the OPUS hLH assay system (the "algorithm" in a broad sense, referring to the entire test system's analytical capability) without human interpretation affecting the quantitative measurement itself, beyond standard laboratory procedures.
7. The type of ground truth used
- Accuracy by Correlation: The "ground truth" for comparison was the results obtained from a "commercially available immunoassay" (the Abbott IMX LH test system, which is the predicate device).
- Accuracy by Recovery: The "ground truth" was established by adding known concentrations of LH to a serum pool with a known endogenous LH concentration, allowing for calculation of expected versus recovered values.
- Interference: The "ground truth" was based on established concentrations of potential interfering substances (TSH, FSH, Prolactin, hOG, hGH) and their known impact, or lack thereof, on LH measurements.
8. The sample size for the training set
Not applicable. This is an immunoassay, not a machine learning algorithm that requires a "training set" in the conventional sense. The assay is based on chemical and immunological principles, and its parameters are set during its development and manufacturing, not "trained" on data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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510(k) Summary of Safety and Effectiveness for OPUS hLH
Manufacturer Name, Address, phone number, contact name and date of 1. preparation.
Behring Diagnostics Inc. Manufacturer: 151 University Ave Westwood, MA 02090 / 617-320-3000 Contact name: Ruth C. Forstadt
Date of preparation: July 22, 1996
Device Name/Classification 2.
Reagents for hLH assay OPUS HLH
Classification number: Class II (862.1485)
3. Identification of the legally marketed device to which the submitter claims equivalence.
Abbott IMX LH test system
4. Proposed Device Description
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.
5. Proposed Device Intended Use
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.
Medical device to which equivalence is claimed and comparison 6. information:
The OPUS hLH test system is substantially equivalent in intended use to the Abbott IMX LH test system. Both products are in vítro diagnostic test systems intended for use as a quantitative measurement of human lutenizing hormone (LH) in serum or plasma. The Abbott IMX LH, like the proposed product, employs the principle of two site or sandwich
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immunoassay. Both methods use a labeled antibody for the quantitative measurement of lutenizing hormone (LH) in human serum or plasma. The OPUS hLH and Abbott IMX LH are both based on a six level calibrator system.
The OPUS hLH differs from the Abbott IMX LH in that the solid phase capture antibody is a mouse monoclonal in the Abbott test, while the solid phase capture antibody is a rabbit monoclonal in the OPUS test. Also, the Abbott IMX LH includes a tri-level control, where as the OPUS hLH test system does not include a control.
Proposed Device Performance Characteristics 7.
Precision of the OPUS hLH test system was evaluated on an OPUS Immunoassay System. Intra-assay precision was determined by the evaluation of three serum pools in replicates of 20 each. %CV's ranged from 4.56% to 6.32%.
Inter-assay precision was determined by the evaluation of three levels of two sets of control sera assayed in triplicate twice a day for five days for a total of thirty replicates. %CV's ranged from 4.55% to 5.64%.
No interference was detected by levels of TSH up to 1,000 mIU/L, FSH up to 1,000 mIU/ml and Prolactin up to 1,000 ng/ml when evaluated using OPUS hLH. hOG at levels up to 50,000 mlU/ml and hGH at levels up to 1,000 ng/ml showed less than 0.6% crossreactivity with the OPUS LH assay.
Accuracy by Correlation
OPUS hLH was compared to a commercially available immunoassay by evaluation of 143 serum samples ranging from 0.79-109 mlU/ml. A correlation coefficient of 0.98 was obtained with a y-intercept value of 1.06 and a slope of 1.06.
Accuracy by Recovery
Recovery was determined by adding LH at different concentrations to a normal human serum pool with a known endogenous LH concentration. The samples were assayed using OPUS hLH in replicates of three. Percent recovery ranged from 95.3% to 98.1%.
§ 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.