VIDAS CHLAMYDIA BLOCKING ASSAY

K955627 · Biomerieux Vitek, Inc. · LJC · Oct 7, 1996 · Microbiology

Device Facts

• Record ID: K955627
• Device Name: VIDAS CHLAMYDIA BLOCKING ASSAY
• Applicant: Biomerieux Vitek, Inc.
• Product Code: LJC · Microbiology
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Indications for Use

The VIDAS Chlamydia Blocking (CHB) assay used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.

Device Story

VIDAS Chlamydia Blocking (CHB) assay; supplemental test for verifying positive/equivocal VIDAS Chlamydia (CHL) assay results. Input: female endocervical and male urethral swab specimens. Principle: fully automated enzyme-linked fluorescent immunoassay (ELFA); detects viable and nonviable Chlamydia antigen. Operation: addition of blocking and reference reagents to VIDAS Chlamydia strips. Output: qualitative antigen detection. Used in clinical laboratory settings. Benefit: faster turnaround (2.5 hours) compared to 48-hour cell culture; provides confirmation of initial screening results.

Clinical Evidence

Performance compared to cell culture. Data provided in Section 8 of submittal (not detailed in summary).

Technological Characteristics

Fully automated enzyme-linked fluorescent immunoassay (ELFA). Requires VIDAS Chlamydia strips, blocking reagents, and reference reagents. Automated processing.

Indications for Use

Indicated for use as a supplemental test to verify positive and equivocal results from female endocervical and male urethral specimens in the VIDAS Chlamydia (CHL) assay.

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).

Reference Devices

• Cell culture

Submission Summary (Full Text)

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K955627

OCT - 7 1996

# SECTION 7
## Summary of Substantial Equivalence

The VIDAS Chlamydia Blocking (CHB) assay used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.

Major similarities include:

1. Both the VIDAS Chlamydia Blocking assay and cell culture detect the presence of viable chlamydial antigens in patient specimens.

Major differences include:

1. Standard cell culture only detects viable antigen in female and male swab specimens. The VIDAS Chlamydia Blocking assay detects both viable and nonviable antigen in female and male swab specimens.

2. The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips. Standard cell culture methodologies are labor intensive and requires confirmation by Giemsa, iodine, or fluorescent antibody staining.

3. Along with the VIDAS Chlamydia assay results for the VIDAS Chlamydia Blocking assay can be obtained within 2 1/2 hours. Cell culture methodologies require at least 48 hours to obtain results.

The data comparing the performance of the VIDAS Chlamydia Blocking assay to that of cell culture can be found in Section 8 of this submittal.