(11 days)
The OPUS B12 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS B12 assay.
The OPUS B12 Controls are liquid controls containing known levels of human Vitamin B12 (Cyanocobalamin) in processed Human Serum Albumin with sodium azide as a preservative. The control is provided at three levels (low, mid and high). The OPUS B12 Control is only for use with the OPUS B12 assay and has not been evaluated for use with other assays.
The provided text describes a 510(k) summary for OPUS B12 Controls, which are quality control materials. The information is focused on demonstrating the precision of these controls, not on validating a diagnostic device's ability to detect or diagnose a condition. Therefore, many of the requested categories in the prompt (e.g., "acceptance criteria and reported device performance" as typically applied to diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "stand-alone study," "type of ground truth" for diagnosis, "training set size") are not applicable or cannot be extracted from this document as the device in question is a quality control material and not a diagnostic algorithm.
However, I can extract information related to the device's performance as a control material, which is precision.
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intra-assay Precision (%CV) | Not explicitly stated but generally expected to be low for quality control materials to ensure consistency within a single run. | Ranged from 4.2% to 9.4% for B12 |
| Inter-assay Precision (%CV) | Not explicitly stated but generally expected to be low for quality control materials to ensure consistency across different runs. | Ranged from 8.41% to 12.53% for B12 |
Study Proving Device Meets Acceptance Criteria (Precision Study):
- Study Design: The precision of the OPUS B12 Controls was evaluated using an OPUS Immunoassay System with the OPUS B12 assay.
- Intra-assay precision: Evaluated by running n=18 for each level of the OPUS control.
- Inter-assay precision: Evaluated by running duplicate determinations for each level of control twice per day (AM and PM) for five days, totaling an n=20.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Intra-assay: n=18 for each control level (low, mid, high).
- Inter-assay: n=20 for each control level (duplicate determinations over 5 days).
- Data Provenance: Not specified, but given it's a product from Behring Diagnostics, Inc. in Westwood, MA, it's likely U.S.-based. The study appears to be prospective, as it involved actively running the controls.
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. This device is a quality control material, not a diagnostic algorithm that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for a control material is its precisely manufactured concentration of the analyte, which is then measured for precision.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 a quality control product, 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 a quality control product, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these controls would be the known, manufactured concentrations of Vitamin B12 within the control materials at each level (low, mid, high). The study evaluated how precisely the OPUS B12 assay measured these known concentrations.
8. The sample size for the training set
- Not Applicable. This product is a control material and does not involve an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
{0}------------------------------------------------
JUL 22 1996
510(k) Summary of Safety and Effectiveness for OPUS B12 Controls
Manufacturer Name, Address, phone number, contact 1. name and date of preparation.
Manufacturer: Behring Diagnostics, Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Contact name: Ruth C. Forstadt
Date of preparation: July 9, 1996
2. Name/Classification: Device
OPUS B12 Controls: Quality Control material (assayed)
Classification number: Class 1 (862.1660)
- Identification of the legally marketed device to which the submitter claims equivalence.
OPUS hCG Controls
4. Proposed Device Description:
The OPUS B12 Controls are liquid controls containing known levels of human Vitamin B12 (Cyanocobalamin) in processed Human Serum Albumin with sodium azide as a preservative. The control is provided at three levels (low, mid and high). The OPUS B12 Control is only for use with the OPUS B12 assay and has not been evaluated for use with other assays.
0000000
{1}------------------------------------------------
5. Proposed Device Intended Use:
The OPUS B12 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS B12 assay.
6. Medical device to which equivalence is claimed and comparison information:
The OPUS B12 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 B12 Controls like the OPUS hCG Controls are a tri-level serum-based matrix controls for specific OPUS assays. Both controls are provided with lot specific values and are for use with the OPUS assays only.
The OPUS B12 Controls differ from the OPUS hCG Controls in that the OPUS B12 Controls are for use with the OPUS B12 assay and contain known levels of Vitamin B12 while the OPUS hCG Controls are for use with the OPUS hCG assay and contain known levels of hCG.
7. Proposed Device Performance Characteristics:
Precision of the OPUS B12 Controls was evaluated on an OPUS Immunoassay System with the OPUS B12 assay. Intra assay precision was evaluated by running an n=18 with each level of the OPUS control. %CV's ranged from 4.2% to 9.4% for B12.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice per dav (AM and PM) for five days to total an n=20. %CV's ranged from 8.41% to 12.53% for B12.
§ 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.