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510(k) Data Aggregation
(58 days)
OPUS BONE ALP
OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.
OPUS Bone ALP is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum.
Here's an analysis of the provided text regarding the Behring Diagnostics Inc. OPUS® Bone ALP 510(k) Notification, focusing on acceptance criteria and study details:
Executive Summary:
The provided document describes a 510(k) notification for the OPUS® Bone ALP assay, a fluorogenic enzyme immunoassay for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum, intended as an aid in the management of patients with diagnosed Paget's disease. The study provided focuses on establishing substantial equivalence to a legally marketed device (Hybritech Tandem-R Ostase) through performance characteristics like precision, recovery, and correlation with the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable intra-assay and inter-assay variability for a diagnostic immunoassay. | Intra-assay %CV: 2.7% to 5.23% (3 control levels, 20 replicates each) |
| Inter-assay %CV: 4.57% to 7.06% (3 control levels, 20 replicates over 5 days) | ||
| Recovery | Acceptable percentage recovery indicating accurate measurement across different analyte concentrations. | 98% to 103% (4 dilutions of elevated bone AP sample into normal human serum) |
| Accuracy by Correlation (vs. predicate device) | High correlation coefficient (ideally >0.95), slope close to 1, and y-intercept close to 0 when compared to a legally marketed device. | Correlation coefficient (r): 0.992 |
| y-intercept: 0.77 | ||
| Slope: 1.06 |
Note: The document does not explicitly state numerical acceptance criteria for each metric. The "implied" criteria are based on standard expectations for diagnostic immunoassay performance for 510(k) submissions demonstrating substantial equivalence. The reported performance values fall within generally accepted ranges for such assays.
Detailed Study Information:
The provided document focuses on analytical performance studies for substantial equivalence. It does not describe a study related to clinical acceptance criteria in the sense of a diagnostic outcome (e.g., sensitivity, specificity for disease detection/management). The "acceptance criteria" here refer to analytical performance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Accuracy by Correlation): 50 serum samples
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It implies the data was collected for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. For this type of analytical performance study (especially correlation against a predicate device), "ground truth" as established by expert consensus is not typically used. The accuracy is determined by comparison to an existing, legally marketed device of the same intended use.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study is an analytical performance comparison, not a clinical study requiring adjudication of diagnostic outcomes.
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 immunoassay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance data presented (precision, recovery, and correlation) represents the standalone performance of the OPUS Bone ALP assay system. Since it's an automated immunoassay, it inherently operates as an "algorithm only" system (in the sense of the assay chemistry and instrument processing samples without direct human interpretive intervention beyond loading/unloading and reviewing automated results).
7. The Type of Ground Truth Used
- For Precision and Recovery: The "ground truth" is inherent to the manufacturing and characterization of the control materials and spiked samples.
- For Accuracy by Correlation: The "ground truth" is effectively the results obtained from the Hybritech Tandem-R Ostase, the legally marketed predicate device to which the OPUS Bone ALP assay is claiming substantial equivalence.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This is an immunoassay kit. The development of reagents and optimization would involve internal validation, but a distinct "training set" in the AI sense is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/machine learning model described in this 510(k) notification.
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