OPUS CK-MB & TOTAL CK CONTROLS

K960275 · Behring Diagnostics, Inc. · JJT · Apr 25, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960275
• Device Name: OPUS CK-MB & TOTAL CK CONTROLS
• Applicant: Behring Diagnostics, Inc.
• Product Code: JJT · Clinical Chemistry
• Decision Date: Apr 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

OPUS CK-MB & Total CK Controls are bovine calf serum-based, tri-level (low, mid, high) quality control materials; contain human CK-MB and rabbit skeletal CK. Used in clinical laboratories to monitor precision/accuracy of OPUS Immunoassay System assays. Provided as lyophilized product; stored at +2° to +8°C. Healthcare providers use control results to verify assay performance and ensure reliable patient testing.

Clinical Evidence

Bench testing only. Precision evaluated on OPUS Immunoassay System. Intra-assay precision (n=20): %CV 7.5-10.7% (CK-MB), 6.8-7.1% (Total CK). Inter-assay precision (n=20): %CV 7.2-9.3% (CK-MB), 5.9-6.6% (Total CK).

Technological Characteristics

Bovine calf serum-based matrix; lyophilized form; contains human CK-MB and rabbit skeletal CK. Designed for use with OPUS Immunoassay System. Storage: +2° to +8°C.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assays in a laboratory setting.

Regulatory Classification

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.

Predicate Devices

• BIORAD Liquichek™ CK-MB Control Levels 1, 2 and 3

Submission Summary (Full Text)

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K960275

Attachment 1

APR 25 1996

# 510(k) Summary of Safety and Effectiveness for OPUS CK-MB & Total CK Controls

1. Manufacturer Name, Address, phone number, contact name and date of preparation:

Manufacturer: Behring Diagnostics Inc.,
151 University Avenue
Westwood, MA 02090
617-320-3153
Contact name: Nancy M Johansen

date of preparation: January 18, 1996

2. Device Name/Classification:

Quality Control Material (assayed)/Class I (862.1660)

3. Identification of the legally marketed device to which the submitter claims equivalence.

BIORAD Liquichek™ CK-MB Control Levels 1, 2 and 3

4. Proposed 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

4. Proposed Device Intended 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.

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attachment

## 5. Medical device to which equivalence is claimed and comparison information:

The OPUS CK-MB & Total CK Controls are substantially equivalent in intended use to 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 assay 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.

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