# K960850: Access Chlamydia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 4, 1997 after 340 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) Syva MicroTrak® II Chlamydia EIA: named in the summary without a submission number

## Indications for use
The Sanofi Diagnostics Pasteur inc. ACCESS® Chlamydia antigen and blocking assays are qualitative, paramagnetic-particle, chemiluminescent enzyme immunoassays for the direct detection and verification of chiamydia antigen in adult male urethral, female endocervical, and male urine specimens, using the ACCESS® Immunoassay System.

Source page: https://510kreport.com/device/K960850
Methodology: https://510kreport.com/methodology