# K032330: CT OIA

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Biostar, Inc.
- Decided: Mar 2, 2004 after 217 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. The FDA summary names its predicate without a number.
- (no number) Thermo Biostar Chlamydia OIA: named in the summary without a submission number

## Indications for use
The Thermo Electron CT OIA assay is an Optical InmunoAssay (OlA) test for the rapid, qualitative detection of chlamydial antigen from female endocervical swab specimens. This test is intended for in vitro diagnostic use as an aid in identifying the presence of Chlamydia trachomatis antigen. The assay is intended for in vitro diagnostic use with symptomatic females in populations at risk for sexually transmitted diseases. CT OIA test results are presumptive evidence for either the presence or absence of C. trachomatis. Definitive laboratory evidence for the presence/ absence of C. trachomatis would need additional testing. CT OIA test results should not preclude empiric treatment of women with overt symptoms of PID. Performance for use in asymptomatic male and female populations has not been established.

Source page: https://510kreport.com/device/K032330
Methodology: https://510kreport.com/methodology