OPUS BONE ALP

K964764 · Behring Diagnostics, Inc. · CIN · Jan 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964764
• Device Name: OPUS BONE ALP
• Applicant: Behring Diagnostics, Inc.
• Product Code: CIN · Clinical Chemistry
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.

Device Story

OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) reagent kit used with OPUS immunoassay analyzers. It measures bone alkaline phosphatase (bone ALP) in human serum. The device utilizes a two-site sandwich immunoassay principle with an enzyme-labeled mouse monoclonal antibody. The system is fully automated, performing fluorometric analysis to quantify bone ALP levels. Results assist clinicians in managing patients with Paget's disease. The device provides quantitative data to monitor disease status or treatment response.

Clinical Evidence

Bench testing only. Precision: Intra-assay %CV 2.7-5.23%; Inter-assay %CV 4.57-7.06%. Accuracy by recovery: 98-103%. Correlation: Compared to commercial immunoassay (n=50, range 5.83-115 ng/ml), correlation coefficient r=0.992, slope 1.06, y-intercept 0.77.

Technological Characteristics

In vitro fluorogenic enzyme immunoassay (ELISA). Reagents used with automated fluorometric OPUS analyzer. Employs two-site sandwich immunoassay principle with enzyme-labeled mouse monoclonal antibody. Six-level calibrator system. Tri-level control included.

Indications for Use

Indicated for patients with diagnosed Paget's disease to aid in clinical management via quantitative measurement of bone alkaline phosphatase in human serum.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• Hybritech Tandem-R Ostase

Submission Summary (Full Text)

{0}

Behring Diagnostics Inc.
OPUS® Bone ALP
510(k) Notification
K964764
510(k) Summary for OPUS Bone ALP
JAN 24 1997

1. Manufactures Name, Address, Telephone, and contact person, date of preparation:

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

Preparation date: November 26, 1996

2. Device Name/ Classification:

OPUS Bone ALP: Alkaline Phosphatase or Isoenzmes Test System
Classification Number: Class II (862.1050)

3. Identification of the legally marketed device:

Hybritech Tandem-R Ostase

4. Proposed Device Description:

OPUS Bone ALP is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum.

5. Proposed Device Intended Use:

OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.

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CONFIDENTIAL

{1}

Behring Diagnostics Inc.
OPUS® Bone ALP
510(k) Notification

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

The OPUS Bone ALP assay is substantially equivalent in intended use to results obtained using the Hybritech Tandem-R Ostase. The Hybritech Tandem-R Ostase, like the proposed product, employs the principle of two site or sandwich immunoassay. Both use a labeled antibody for the quantitative measurement of bone ALP in human serum. The OPUS Bone ALP and the Hybritech Tandem-R Ostase are based on a six level calibrator system.

The OPUS Bone ALP differs from the Hybritech Tandem-R Ostase in that the mouse monoclonal antibody is labeled with $^{125}$I in the Hybritech Tandem-R Ostase, while the enzyme labeled antibody is a mouse monoclonal in the OPUS Bone ALP test. Also, the OPUS Bone ALP includes a tri-level control, where as the Hybritech Tandem-R Ostase test includes a bi-level control. Additionally, the OPUS Bone ALP is used with a fully automated fluorometric instrument system, while the Hybritech Tandem-R Ostase uses a gamma counter.

## 7. Proposed Device Performance Characteristics:

### Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 2.7% to 5.23%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.57% to 7.06%.

### Accuracy by Recovery

Recovery was determined by making four dilutions of an elevated Bone AP patient sample into a normal human serum pool. The samples were assayed using OPUS Bone ALP in duplicate. Percent recovery ranged from 98% to 103%.

### Accuracy by Correlation

OPUS Bone ALP was compared to a commercially available immunoassay by evaluation of 50 serum samples ranging from 5.83 to 115 ng/ml. A correlation coefficient of 0.992 was obtained with a y-intercept value of 0.77 and a slope of 1.06.

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CONFIDENTIAL