# K033865: Ideia Pce Chlamydia

- Pathway: 510(k) (Special)
- Applicant: Dakocytomation, Ltd.
- Decided: Jan 21, 2004 after 40 days
- Product code: LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group))
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DakoCytomation Ltd IDEIA T M PCEChlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.

Source page: https://510kreport.com/device/K033865
Methodology: https://510kreport.com/methodology