# K982210: Modification of Syva Microtrak II Chlamydia Eia

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Jul 9, 1998 after 16 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 no predicate by number.

## Indications for use
The Syva MicroTrak II Chlamydia EIA is an enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens. The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist

Source page: https://510kreport.com/device/K982210
Methodology: https://510kreport.com/methodology