(40 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for the IDEIA™ PCE Chlamydia immunoassay. It does not contain the detailed study information regarding acceptance criteria or device performance that you are requesting.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means it has been determined to be as safe and effective as a previously cleared device. However, it does not provide the specific performance data, acceptance criteria, or study details that would typically be found in a clinical study report or a more comprehensive submission document.
Therefore, I cannot provide the information requested in your prompt based on the provided text. To answer your questions, I would need a different type of document, such as a detailed clinical study report, a premarket notification summary, or the full 510(k) submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)_
§ 866.3120 Chlamydia serological reagents.
(a)
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 genusChlamydia 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).(b)
Classification. Class I (general controls).