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.

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

AI/ML Overview

This 510(k) premarket notification describes the OPUS CK-MB & Total CK Controls, which are quality control materials, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories are not applicable.

Here's an adaptation of the requested information for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance (OPUS CK-MB & Total CK Controls)
CK-MB Intra-assay Precision (%CV)
Low Level	7.5%
Mid Level	(Not specified, but within the 7.5% to 10.7% range)
High Level	10.7%
Overall Range	7.5% to 10.7%
Total CK Intra-assay Precision (%CV)
Low Level	6.8%
Mid Level	(Not specified, but within the 6.8% to 7.1% range)
High Level	7.1%
Overall Range	6.8% to 7.1%
CK-MB Inter-assay Precision (%CV)
Low Level	7.2%
Mid Level	(Not specified, but within the 7.2% to 9.3% range)
High Level	9.3%
Overall Range	7.2% to 9.3%
Total CK Inter-assay Precision (%CV)
Low Level	5.9%
Mid Level	(Not specified, but within the 5.9% to 6.6% range)
High Level	6.6%
Overall Range	5.9% to 6.6%

Note: The document does not explicitly state "acceptance criteria" values in the traditional sense for diagnostic devices. Instead, it reports the precision performance. For quality control materials, the expectation is generally that the precision falls within acceptable ranges for laboratory use, often defined internally by the manufacturer or by regulatory guidance for QC materials.

2. Sample size used for the test set and the data provenance:

Intra-assay precision: n=20 for each level of the OPUS controls.
Inter-assay precision: Duplicate determinations for each level of control, run twice per day (AM and PM) for five days, totaling n=20.
Data Provenance: Not explicitly stated, but assumed to be prospective data collected by Behring Diagnostics Inc. for the purpose of this submission (manufacturer data). Country of origin is not specified.

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. Its "ground truth" relates to its inherent chemical stability and concentration, which is determined by analytical methods during manufacturing, not by expert interpretation.

4. Adjudication method for the test set:

Not Applicable. As a quality control material, there is no "adjudication" of results in the clinical sense. The performance is based on analytical precision.

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 material, not a diagnostic device, and does not involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a quality control material, not an algorithm or an AI device. The "performance" is its analytical precision.

7. The type of ground truth used:

For quality control materials, the "ground truth" (or target values) for CK-MB and Total CK levels in the controls are established during the manufacturing process through chemical analysis and calibration, likely against reference materials. The document states they contain "known levels of human CK-MB and rabbit skeletal CK."

8. The sample size for the training set:

Not Applicable. This is a quality control material; there is no "training set" in the context of machine learning or diagnostic algorithm development. Its characteristics are determined by manufacturing and quality assurance processes.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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K960075

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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.

Regulation Number and Section

§ 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.