IDEIA PCE CHLAMYDIA

K033865 · Dakocytomation, Ltd. · LJC · Jan 21, 2004 · Microbiology

Device Facts

• Record ID: K033865
• Device Name: IDEIA PCE CHLAMYDIA
• Applicant: Dakocytomation, Ltd.
• Product Code: LJC · Microbiology
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended Use

DakoCytomation Ltd IDEIA™ PCE Chlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.

Device Story

Modified IDEIA™ Chlamydia Test; modification involves enzyme conjugate and enzyme amplification color development components. Device detects Chlamydia trachomatis; utilizes enzyme-linked immunoassay technology. Intended for clinical laboratory use; provides diagnostic results to healthcare providers for patient management. Modification maintains fundamental scientific technology of previously cleared device.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Immunoassay utilizing dual amplification technology for antigen detection. Form factor is a diagnostic test kit.

Indications for Use

Indicated for the detection of Chlamydia trachomatis.

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).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIVD Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K033865

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
IDEIA™ Chlamydia Test, K911430

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for
Enzyme conjugate and enzyme amplification color development

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics has been provided.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosed

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis the device has been determined to be substantially equivalent to the previously cleared device.