# K936054: Imx Select Chlamydia

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 30, 1996 after 891 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) isolation of C. trachomatis in cell culture: named in the summary without a submission number

## Indications for use
IMx SELECT Chlamydia is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative detection of chlamydial LPS antigen and is indicated for use in testing female endocervical swab specimens, and male urethral swab specimens from symptomatic individuals to identify Chlamydia trachomatis.

Source page: https://510kreport.com/device/K936054
Methodology: https://510kreport.com/methodology