(97 days)
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No
The document describes quality control materials for an immunoassay system and does not mention any AI/ML components or functionalities.
No
The device is described as quality control material for monitoring precision and accuracy of an assay, not for treating a disease or condition.
No
The device is described as "quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assay," not to diagnose patients.
No
The device description explicitly states the controls are "bovine calf serum based controls consisting of three levels... containing known levels of human CK-MB and rabbit skeletal CK," indicating a physical, biological material, 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 "intended for use as quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assay." This indicates that the device is used in vitro (outside the body) to assess the performance of another diagnostic assay.
- Device Description: The description mentions that the controls are "bovine calf serum based controls containing known levels of human CK-MB and rabbit skeletal CK." This further confirms that the device is a reagent or material used in a laboratory setting for diagnostic purposes.
Quality control materials used to monitor the performance of diagnostic assays are a common type of IVD.
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Intended Use / Indications for Use
The OPUS CK-MB & Total CK Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assay.
Product codes
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Device Description
The OPUS CK-MB & Total CK Controls are bovine calf serum based controls consisting of three levels (low, mid and high) containing known levels of human CK-MB and rabbit skeletal CK
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
An n=20 with each level of the OPUS controls was used for intra-assay precision evaluation. Duplicate determinations for each level of control were run twice per day (AM and PM) for five days to total an n=20 for inter-assay precision evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision of the OPUS CK-MB & Total CK Controls was evaluated on an OPUS Immunoassay System with the OPUS CK-MB and Total CK assays.
Intra assay precision: n=20 with each level of the OPUS controls. %CV's ranged from 7.5% to 10.7% for CK-MB and 6.8% to 7.1% for Total CK.
Inter assay precision: n=20 (duplicate determinations for each level of control twice per day for five days). %CV's ranged from 7.2% to 9.3% for CK-MB and 5.9% and 6.6% for Total CK.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
%CV (Coefficient of Variation)
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.
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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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APR 2 5 1996
510(k) Summary of Safety and Effectiveness for OPUS CK-MB & Total CK Controls
Manufacturer Name, Address, phone number, contact name and date 1. preparation: of
Behring Diagnostics Inc., Manufacturer: 151 University Avenue Westwood, MA 02090 617-320-3153 Contact name: Nancy M Johansen
date of preparation: January 18, 1996
Device Name/Classification: 2.
Quality Control Material (assayed)/Class I (862.1660)
Identification of the legally marketed device to which the submitter 3. claims equivalence.
BIORAD Liquichek™ CK-MB Control Levels 1, 2 and 3
Proposed Device Description: 4.
The OPUS CK-MB & Total CK Controls are bovine calf serum based controls consisting of three levels (low, mid and high) containing known levels of human CK-MB and rabbit skeletal CK
Proposed Device Intended Use: 4.
The OPUS CK-MB & Total CK Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assay.
CODDOS
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5. Medical device to which equivalence is claimed and comparison information:
The OPUS CK-MB & Total CK Controls are substantially equivalent in intended use t o the BIORAD Liquichek™ CK-MB Controls. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS CK-MB & Total CK Controls like the Liquichek™ CK-MB Controls are a tri-level serum-based matrix controls for specific cardiac assays. Both controls are provided with lot specific values. The OPUS CK-MB & Total CK Controls and the Liquichek™ CK-MB Controls both contain two analytes. Both the OPUS CK-MB & Total CK Controls and the Liquichek™ CK-MB Controls are provided with known values for Behring OPUS Immunoassay System.
The Behring Diagnostics' OPUS CK-MB & Total CK Controls differ from the BIORAD Liquichek™ CK-MB Controls in that the OPUS CK-MB & Total CK Controls can be stored at +2° to +8°C, while the BIORAD controls must be stored at -10° to -20°C. Also the OPUS CK-MB & Total CK Control is provided as lyophilized control while the Liquichek™ CK-MB Controls are provided in liquid form.
6. Proposed Device Performance Characteristics:
Precision of the OPUS CK-MB & Total CK Controls was evaluated on an OPUS Immunoassay System with the OPUS CK-MB and Total CK assays. Intra assav precision was evaluated by running an n=20 with each level of the OPUS controls. %CV's ranged from 7.5% to 10.7% for CK-MB and 6.8% to 7.1% for Total CK.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice per day (AM and PM) for five days to total an n=20. %CV's ranged from 7.2% to 9.3% for CK-MB and 5.9% and 6.6% for Total CK.