(11 days)
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No
The 510(k) summary describes a liquid quality control material for an immunoassay, with no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a quality control material intended to monitor the precision and accuracy of an assay, not for treating any condition.
No
The device is described as "quality control material to monitor the precision and accuracy of the OPUS B12 assay" and contains "known levels of human Vitamin B12". It is not used to diagnose a patient's condition but rather to ensure the diagnostic assay itself is working correctly.
No
The device description clearly states it is a liquid control material containing human Vitamin B12 in processed Human Serum Albumin, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used "to monitor the precision and accuracy of the OPUS B12 assay." This is a classic function of quality control materials used in laboratory testing.
- Device Description: The description details the composition of the controls, which are liquid materials containing known levels of an analyte (Vitamin B12) in a biological matrix (processed Human Serum Albumin). This is consistent with the nature of IVD quality control materials.
- Performance Studies: The document includes a summary of performance studies evaluating the precision of the controls when used with the specified assay. This type of performance evaluation is standard for IVD devices, particularly quality control materials.
- Predicate Device: The mention of a "Predicate Device(s)" (OPUS hCG Controls) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While the device itself is a control material and not the primary diagnostic assay, it is an essential component used in vitro (outside the body) to ensure the reliability and accuracy of a diagnostic test (the OPUS B12 assay). Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OPUS B12 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS B12 assay.
Product codes
862.1660
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OPUS hCG Controls
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
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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.