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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, symbolizing care and protection. The seal is in black and white.

JAN 2 1 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jennie Oates Regulatory Compliance Officer DakoCytomation Ltd. Denmark House, Angel Drove Ely, Cambridgeshire United Kingdom CB7 4ET

k033865 Re:

Trade/Device Name: IDEIA™ PCE Chlamydia Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: Class I Product Code: LJC Dated: December 5, 2003 Received: December 24, 2003

Dear Ms. Oates:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave review a jd have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abo battler in to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimer to provisions of the recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may), ates s royisions of the Act include requirements for annual registration, listing of general controll pro factive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rise is charized (1) in the major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA be round in further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I fouse oe arribed a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must of any I vierall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice SPAC Part 8679, the complex systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sagarths

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K033865

Device Name: IDEIA™ PCE Chlamydia

Indications For 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.

× Prescription Use _ (Part 21 CFR 801 Subpart D)

-

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO33863 510(k)_