# K905787: Vidas Chlamydia Assay Vitek Immundiag Assay Syst

- Pathway: 510(k) (Traditional)
- Applicant: Vitek Systems, Inc.
- Decided: Apr 29, 1991 after 123 days
- Product code: LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group))
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 8, 2011 · Not classified · Z-3129-2011: Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.

Source page: https://510kreport.com/device/K905787
Methodology: https://510kreport.com/methodology