# K955627: Vidas Chlamydia Blocking Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Oct 7, 1996 after 301 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) cell culture: named in the summary without a submission number

## Indications for use
The VIDAS Chlamydia Blocking (CHB) assay used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.

Source page: https://510kreport.com/device/K955627
Methodology: https://510kreport.com/methodology