(40 days)
Not Found
Not Found
No
The summary describes an immunoassay for detecting a specific antigen and contains no mention of AI or ML technology.
No
The device is an immunoassay for detecting Chlamydia antigen, which is a diagnostic purpose, not a therapeutic one. It identifies a condition rather than treating or preventing it.
Yes
The device is described as an immunoassay for the qualitative detection of Chlamydia lipopolysaccharide antigen, which is used to identify the presence of a specific condition or disease, thus serving a diagnostic purpose.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect the presence of a substance. This involves physical reagents and laboratory procedures, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines." This describes a test performed on samples taken from the human body in vitro (outside the body) to diagnose or detect a specific condition (Chlamydia).
- Sample Type: The samples used (swabs and urine) are biological specimens taken from a human.
- Detection Method: Immunoassays are a common type of in vitro diagnostic test.
Therefore, based on the provided information, the DakoCytomation Ltd IDEIA™ PCE Chlamydia device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LJC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urethral and endocervical swabs and male urines.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
Page 2
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
2
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)_