# K063675: Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Sep 24, 2007 after 287 days
- Product code: LJP (Antiserum, Fluorescent, Chlamydia Trachomatis)
- 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
Longest line of descent: 1 generation back to K864389 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864389: Chlamydiae Flourescent Monoclonal Antibody Test, American Micro Scan (1986) Summary page 1.
- K864663: Pathfinder Chlamydia Culture Confirmation System, Kallestad Diag, A Div. of Erbamont, Inc. (1987) Summary page 1.
- K895839: Pathodx Chlamydia Culture Confirmation PKCC1, Diagnostic Products Corp. (1990) Summary page 1.

## Indications for use
The Diagnostic Hybrids' D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative detection of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Performance has not been established with direct patient specimens.

Source page: https://510kreport.com/device/K063675
Methodology: https://510kreport.com/methodology