CIBA CORNING ACS;180 DPD ASSAY

K963251 · Ciba Corning Diagnostics Corp. · JMM · Oct 15, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963251
• Device Name: CIBA CORNING ACS;180 DPD ASSAY
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: JMM · Clinical Chemistry
• Decision Date: Oct 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1400
• Device Class: Class 1

Indications for Use

The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems

Device Story

Competitive immunoassay using direct chemiluminescent technology; performed on ACS:180 automated system. Input: urine sample. Mechanism: DPD in sample competes with pyridinoline bound to paramagnetic particles for monoclonal mouse anti-DPD antibody labeled with acridinium ester. Output: relative light units (RLUs) inversely proportional to DPD concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in evaluating bone resorption status.

Clinical Evidence

Bench testing only. Method comparison performed on 752 urine samples (range 6-350 nM) against an alternate ELISA method; correlation coefficient r=0.961; regression equation: y=1.05x + 2.13. Total precision (%CV) ranged from 2.84% to 9.76%. Analytical sensitivity (minimum detectable concentration) is 5.0 nM.

Technological Characteristics

Competitive chemiluminescent immunoassay. Components: paramagnetic particles, monoclonal mouse anti-DPD antibody, acridinium ester-labeled goat anti-mouse antibody. Automated system (ACS:180) measures light output (RLUs).

Indications for Use

Indicated for the quantitative measurement of deoxypyridinoline (DPD) in urine samples to assess bone resorption.

Regulatory Classification

Identification

A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Predicate Devices

• Pyrilinks®-D (Metra Biosystems, Inc)

Submission Summary (Full Text)

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Company Confidential
K963251
OCT 15 1996

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitters Information

Contact person: William J. Pignato
Director of Regulatory Affairs

Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]

Date Summary Prepared: August 15, 1996

## 2. Device Information

Proprietary Name: Ciba Corning ACS:180 DPD Assay
Common Name: Assay for Deoxypyridinoline

## 3. Predicate Device Information

Name: Pyrilinks®-D
Manufacturer: Metra Biosystems, Inc

## 4. Device Description

The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pyridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat anti-mouse antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system.

## 5. Statement of Intended Use

The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems

Ciba Corning ACS:180 DPD
August 15, '996
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Company Confidential

## 6. Summary of Technological Characteristics

The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology

## 7. Performance Characteristics

### Sensitivity

The ACS:180 DPD assay measures DPD concentrations up to 350 nM with a minimum detectable concentration of 5.0 nM. Analytical sensitivity is defined as the concentration of DPD that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 20 replicate determinations of the DPD zero standard.

### Method Comparison

For 752 urine samples in the range of 6 to 350 nM, the relationship between ACS:180 DPD and an alternate ELISA method is described by the equation:

$$
\text{ACS:180 DPD} = 1.05 \times (\text{alternate method}) + 2.13
$$

Correlation coefficient (r) = 0.961

### Precision

Total precision (%CV) ranged from 2.84 to 9.76

Ciba Corning ACS:180 DPD
August 15, '996
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