OPUS B12 CONTROLS

K962694 · Behring Diagnostics, Inc. · JJX · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962694
• Device Name: OPUS B12 CONTROLS
• Applicant: Behring Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

OPUS B12 Controls consist of liquid, tri-level (low, mid, high) quality control material containing known concentrations of Vitamin B12 (Cyanocobalamin) in a processed Human Serum Albumin matrix with sodium azide preservative. Used exclusively with the OPUS Immunoassay System for the OPUS B12 assay. Laboratory personnel utilize these controls to monitor assay precision and accuracy by comparing observed results against provided lot-specific values. This monitoring ensures the reliability of patient Vitamin B12 testing, aiding clinicians in diagnosing and managing B12-related conditions.

Clinical Evidence

Bench testing only. Precision evaluated on OPUS Immunoassay System. Intra-assay precision (n=18 per level) yielded %CVs of 4.2% to 9.4%. Inter-assay precision (n=20 per level, duplicate determinations twice daily for five days) yielded %CVs of 8.41% to 12.53%.

Technological Characteristics

Liquid, tri-level serum-based matrix. Contains Vitamin B12 (Cyanocobalamin) and sodium azide preservative. Designed for use with OPUS Immunoassay System. No specific ASTM standards cited.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision and accuracy of the OPUS B12 assay in clinical laboratory settings.

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

• OPUS hCG Controls

Submission Summary (Full Text)

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K962694
JUL 22 1996

510(k) Summary of Safety and Effectiveness for OPUS B12 Controls

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

Manufacturer: Behring Diagnostics, Inc.
151 University Avenue
Westwood, MA 02090
617-320-3117
Contact name: Ruth C. Forstadt

Date of preparation: July 9, 1996

2. Device Name/Classification:

OPUS B12 Controls: Quality Control material (assayed)

Classification number: Class 1 (862.1660)

3. 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 day (AM and PM) for five days to total an n=20. %CV's ranged from 8.41% to 12.53% for B12.

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