ACCESS CHLAMYDIA ASSAY

K960850 · Bio-Rad Laboratories, Inc. · LJC · Feb 4, 1997 · Microbiology

Device Facts

• Record ID: K960850
• Device Name: ACCESS CHLAMYDIA ASSAY
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: LJC · Microbiology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended Use

The Sanofi Diagnostics Pasteur Inc. ACCESS® Chlamydia antigen and blocking assays are qualitative, paramagnetic-particle, chemiluminescent enzyme immunoassays for the direct detection and verification of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.

Device Story

ACCESS® Chlamydia Reagents utilize paramagnetic-particle, chemiluminescent enzyme immunoassay technology on the ACCESS® Immunoassay System. Device processes clinical specimens (urethral, endocervical, urine) to detect Chlamydia antigen. System automates assay steps; provides qualitative results to clinicians. Used in laboratory settings to aid in Chlamydia diagnosis. Output assists healthcare providers in identifying infection, enabling timely patient treatment and management.

Clinical Evidence

Clinical study compared ACCESS® Chlamydia to culture/DFA on 2092 urogenital and 572 male urine specimens. Sensitivity ranged 56-100%, specificity 99-100% across populations (high/low risk females, symptomatic/asymptomatic males). Concordance with Syva MicroTrak® II was 98.1% (urogenital) and 95.4% (urine). Precision testing reported total CVs of 11.9-21.1%.

Technological Characteristics

Paramagnetic-particle, chemiluminescent enzyme immunoassay. Utilizes ACCESS® Immunoassay System platform. Qualitative detection method.

Indications for Use

Indicated for qualitative detection and verification of Chlamydia antigen in adult male urethral, female endocervical, and male urine specimens.

Regulatory Classification

Identification

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Predicate Devices

• Syva MicroTrak® II Chlamydia EIA

Submission Summary (Full Text)

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SANOFI DIAGNOSTICS PASTEUR, INC.
1000 LAKE HAZELTINE DRIVE
CHASKA, MINNESOTA 55318-1084 U.S.A.
TEL: [phone]
FEB - 4 1997
sanofi Pasteur
K960850

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
February 29, 1996

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

## 1. General Information

Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318
[phone]
Katia Breslawec

Device Classification Name: Chlamydia Serological Reagents
Device Trade Name: ACCESS® Chlamydia Reagents

## 2. Predicate Device

Syva MicroTrak® II Chlamydia EIA
Syva Company
3403 Yerba Buena Road P.O. Box 49013
San Jose, CA 95161

## 3. Device Description

The Sanofi Diagnostics Pasteur Inc. ACCESS® Chlamydia antigen and blocking assays are qualitative, paramagnetic-particle, chemiluminescent enzyme immunoassays for the direct detection and verification of chlamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.

## 4. Summary of Studies

In clinical studies, the ACCESS® Chlamydia was compared to culture or DFA on 2092 urogenital and 572 male urine specimens. The respective sensitivity, specificity, PPV, and NPV by population category were:

| high risk females | 86% | 99.7% | 96% | 99% |
| --- | --- | --- | --- | --- |
| low risk females | 100% | 100% | 100% | 100% |
| symptomatic males | 93% | 99.7% | 98% | 99% |
| symptomatic males urine | 88% | 99% | 94% | 98% |
| asymptomatic males | 88% | 100% | 100% | 99.5% |
| asymptomatic males urine | 56% | 100% | 100% | 98% |

A comparison to the Syva MicroTrak® II Chlamydia EIA was done on 1518 urogenital and 303 male urine specimens. The concordance was 98.1% and 95.4%, respectively.

Representative data for within run and total precision are 4.2% and 11.9% for negative, 5.6% and 17.5% for low positive, and 3.6% and 21.1% for high positive specimens.

## 5. Conclusion

The Sanofi Diagnostics Pasteur ACCESS® Chlamydia is substantially equivalent to a standard laboratory reference method (cell culture) and to another kit currently in commercial distribution for the direct detection of chlamydia in adult female endocervical, male urethral, and male urine specimens.

Kallested
GeneticSystems
DIAGNOSTICS Pasteur