(24 days)
The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.
The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.
The provided text describes a 510(k) summary for "OPUS Myoglobin Controls," which are quality control materials. It does not describe a study involving a diagnostic device that detects or diagnoses a condition, nor does it present acceptance criteria and performance data in the typical sense of a diagnostic accuracy study.
Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission for quality control materials.
However, I can extract the closest analogous information regarding "acceptance criteria" (implied performance expectations for a QC material) and "device performance" (results of the precision study).
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intra-assay Precision: Not explicitly stated, but generally, acceptable CVs for QC materials in immunoassays are typically low (e.g., < 10% or < 15%) | Intra-assay Precision (n=20): %CVs ranged from 4.27% to 6.05% for myoglobin. |
| Inter-assay Precision: Not explicitly stated, but generally, acceptable CVs for QC materials in immunoassays are typically low to moderate (e.g., < 15% or < 20%) | Inter-assay Precision (n=8): %CVs ranged from 6.55% to 10.54% for myoglobin. |
Explanation of "Implied" Acceptance Criteria: The document describes the results of the precision studies but does not explicitly state pre-defined acceptance criteria (e.g., "The intra-assay %CV must be less than X%"). However, the reported CVs (4.27% to 10.54%) are generally considered good for immunoassay quality control materials, implying they met the manufacturer's internal performance expectations for precision.
Regarding the other requested points:
- 2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: For intra-assay precision, n=20 for each control level. For inter-assay precision, n=8 (duplicate determinations run twice over 15 days).
- Data Provenance: Not explicitly stated, but implied to be from Behring Diagnostics, Inc. (manufacturer) in Westwood, MA, USA. This would be prospective testing conducted by the manufacturer.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation for ground truth.
- 4. Adjudication method for the test set: Not applicable. See point 3.
- 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 not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For quality control materials, the "ground truth" is the known concentration of the analyte (myoglobin in this case) added to the control, which is then measured by the assay.
- 8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- 9. How the ground truth for the training set was established: Not applicable. See point 8.
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510(k) Summary of Safety and Effectiveness for OPUS Myoglobin Controls
AUG 15 1996
Manufacturer Name, Address, phone number, contact 1. name and date of preparation.
Behring Diagnostics, Inc. Manufacturer: 151 University Avenue Westwood, MA 02090 617-320-3117 Contact name: Ruth C. Forstadt
Date of preparation: July 17, 1996
Name/Classification: 2. Device
OPUS Myoglobin Controls: Quality Control material (assayed)
Class 1 (862.1660) Classification number:
Identification of the legally marketed device to which 3. the submitter claims equivalence.
OPUS hCG Controls
Proposed Device Description: 4 .
The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.
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Proposed Device Intended Use: 5.
The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.
Medical device to which equivalence is claimed and 6. comparison information:
The OPUS Myoglobin Controls are substantially equivalent in intended use to the OPUS hCG Controls. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS Myoglobin Controls, like the OPUS hCG Controls, are a tri-level serum-based matrix control for specific OPUS assays. Both controls are provided with lot specific values and are for use with the OPUS assays only.
The OPUS Myoglobin Controls differ from the OPUS hCG Controls in that the OPUS Myoglobin Controls are for use with the OPUS Myoglobin assay and contain known levels of myoglobin, while the OPUS hCG Controls are for use with the the OPUS hCG assay and contain known levels of hCG. Also, the OPUS Myoglobin control is provided as a lyophilized control while the OPUS hCG controls are provided in a liquid form.
Proposed Device Performance Characteristics: 7.
Precision of the OPUS Myoglobin Controls was evaluated on an OPUS Immunoassay System with the OPUS Myoglobin assay. Intra assay precision was evaluated by running an n=20 with each level of the OPUS control. %CV's ranged from 4.27% to 6.05% for myoglobin.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice over a 15 day period to total an n=8. %CV's ranged from 6.55% to 10.54% for myoglobin.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.